Postoperative PainERPOSPNCT06195176
Randomized Clinical Trial: Effect of an Exercise Routine on Postoperative Shoulder Pain in Laparoscopic Hysterectomy
A study testing Shoulder exercises and Hand exercises in people with Postoperative Pain and Laparoscopic Hysterectomy for Benign Conditions, run by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes at 1 site in Mexico.
Trial summary
This is a clinical trial aimed at understanding the impact of a shoulder exercise routine on postoperative shoulder pain in patients who have undergone laparoscopic hysterectomy. Main Questions: 1. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Postoperative Pain, Laparoscopic Hysterectomy for Benign Conditions
- What is being tested?
- Shoulder exercises and Hand exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteMexico
- Study dates
- 20 Jan 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing uncomplicated total laparoscopic hysterectomy at INPer for benign pathology.
- Mixed anesthesia.
- Placement of shoulder pads on the surgical table during surgery.
- Adults who agree to participate and sign informed consent.
Who cannot join
- Patients with preoperative shoulder pain.
- Patients who had intraabdominal CO2 pressure greater than 15 mm Hg during surgery.
- Patients who received a postoperative analgesia pump.
- Patients participating in another protocol
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
National Institute of Perinatology
Mexico City, Mexico City, 11000
Andrea A Olguin-Ortega, MD, 5555209900 ext. 221, olguin.andrea@gmail.com
Enrique Reyes-Muñoz, PhD, 5555209900 ext. 307, dr.enriquereyes@gmail.com
About this study
Official title: Randomized Clinical Trial: Effect of an Exercise Routine on Postoperative Shoulder Pain in Total Laparoscopic Hysterectomy
This is a clinical trial aimed at understanding the impact of a shoulder exercise routine on postoperative shoulder pain in patients who have undergone laparoscopic hysterectomy.
Main Questions:
Read more
- Does implementing a shoulder exercise routine immediately after laparoscopic hysterectomy reduce postoperative shoulder pain?
Brief Explanation: We want to see if doing shoulder exercises right after laparoscopic hysterectomy can help reduce the pain they might feel in their shoulders. This kind of pain can happen because of the gas used during the surgery. Using exercises could be a cost-effective and easy way to help patients recover better after the surgery.
Hypothesis: We think that doing shoulder exercises right after laparoscopic hysterectomy will lower the amount of shoulder pain patients experience after the surgery.
Objective: Our goal is to find out if a shoulder exercise routine can make a difference in how much shoulder pain patients have right after laparoscopic hysterectomy.
How We'll Do It: This study aims to evaluate the impact of a shoulder exercise routine on reducing postoperative shoulder pain in women who have undergone total laparoscopic hysterectomy at the National Institute of Perinatology. Recognizing the high prevalence and intensity of post-laparoscopy shoulder pain, the study compares the effectiveness of shoulder exercises to hand exercises in managing this pain. Patients, selected based on specific inclusion and exclusion criteria, will be randomly assigned to either the shoulder or hand exercise group. The exercise regimen involves performing specific movements at regular intervals during the immediate postoperative period, except at night. Pain intensity will be measured using a Visual Analog Scale at various intervals postoperatively. The study controls for several variables, including visceral and incisional pain, duration of pneumoperitoneum, analgesic use, and patient characteristics like BMI and comorbidities, to ensure a comprehensive understanding of the exercises' effectiveness. The hypothesis tests whether shoulder exercises can reduce shoulder pain more effectively than hand exercises. This research could have significant implications for enhancing recovery and pain management strategies post-laparoscopy.
Read the detailed description
Main Objective
To evaluate the effect of a shoulder exercise routine versus a hand exercise routine on the intensity of shoulder pain in women postoperatively following total laparoscopic hysterectomy at the National Institute of Perinatology
Specific Objectives:
- Describe the frequency and intensity of shoulder pain in women postoperatively following total laparoscopic hysterectomy.
- Determine the effect of the shoulder exercise routine versus a hand exercise routine on the intensity of shoulder pain in women postoperatively following total laparoscopic hysterectomy.
- Evaluate the adjusted effect of the proposed intervention on pain after identifying potential confounding variables. Postoperative management will be similar in both intervention groups, so we do not expect to make adjustments. In the event that confounding variables are identified, we will address them accordingly.
Hypothesis:
H0 (Null Hypothesis): Shoulder exercises in the postoperative period do not reduce shoulder pain by at least one point on the Visual Analog Scale compared to a hand exercise routine.
Description of the Procedure
Only patients scheduled for surgery at 8:00 AM will be considered to ensure that the exercise routine has a consistent duration for all patients during the postoperative period. Inclusion criteria involve patients receiving mixed anesthesia, and all patients will be positioned on the surgical table with shoulder pads and a hip angulation of 15 degrees with inflatable leg supports. Patients with negative pressure drains will be excluded from the study. The principal investigator will be blinded to the randomization group, and patient assessments will be conducted by another investigator.
Once a patient agrees to participate in the project and signs the informed consent authorization, they will be randomized into one of the treatment groups. Randomization will be done using opaque, sealed envelopes contained in a box. Each envelope will specify the assigned intervention group. An equal number of envelopes for both intervention groups will be prepared in advance and shuffled. Patients will choose an envelope. The box with envelopes will be safeguarded by the principal investigator using a simple randomization method generated by envelopes from an Excel-generated number table, distributed in sets of 8 until reaching the total of 112 patients.
Patients randomized to the exercise routine group will be instructed, upon recovery, about the exercise routine. The routine consists of lifting the shoulders as high as possible towards the ears, holding for 3 seconds, and then resting. This should be repeated 10 times at the beginning of each hour during the immediate postoperative period while on the hospital ward. The routine will be suspended during the night. The procedure will be standardized, as the principal investigator will personally explain and demonstrate it to all involved individuals who are responsible for explaining it to the patients. Telephone and in-person reminders will be made, and pain in the shoulders, incisions, and perineum will be recorded upon leaving the recovery room, at 6 hours and 24 hours postoperatively, as well as during the follow-up consultations on day 7 and day 30 post-surgery.
A data recording sheet with a visual analog scale from 0 to 10, representing the pain graphically, will be used to document pain levels upon leaving recovery, at 6 and 24 hours postoperatively, along with the time and dosage of analgesics and any rescue analgesics used. Additionally, patient adherence to the exercise routine will be recorded, allowing them to document their hospitalization days and the hours of the day when they perform the exercises.
Population: Patients postoperatively following uncomplicated total laparoscopic hysterectomy for benign conditions in the Department of Gynecology at INPer (National Institute of Perinatology).
Sample Type: Random consecutive cases, generated using a random number table in Excel.
Sample Size: Calculated using a formula for the difference in means of independent samples, considering a reported Visual Analog Scale (VAS) taing into account an VAS score reported at 6 hours postoperative witha mean in the experimental group of 3.0 (SD +-2.0) and the control group of 4.5 (SD +2.0) with a two tailed hypothesis, and statistical power 80% and an alphe error of 0.05% the sudy requiered a sample size of 28 per group plus 15% of possible dropout rate, the result is 33 patients per group and 66 in the total sample.
Sampling Type: Random consecutive cases.
Definition of Units of Observation: Patients postoperatively following uncomplicated total laparoscopic hysterectomy in the Department of Gynecology at INPer.
Definition of Control Group: Patients postoperatively following uncomplicated total laparoscopic hysterectomy in the Department of Gynecology at INPer, randomized to the control group, which will perform a series of hand exercises.
Inclusion Criteria:
- Patients undergoing uncomplicated total laparoscopic hysterectomy at INPer for benign pathology.
- Mixed anesthesia.
- Placement of shoulder pads on the surgical table during surgery.
- Adults who agree to participate and sign informed consent.
Exclusion Criteria:
- Patients with preoperative shoulder pain.
- Patients who had intraabdominal CO2 pressure greater than 15 mm Hg during surgery.
- Patients who received a postoperative analgesia pump.
- Patients participating in another protocol.
Elimination Criteria:
- Patients with postoperative complications requiring reoperation or Intensive Care Unit admission x Dependent Variable:
Shoulder pain referred by the patient on a Visual Analog Scale (VAS) ranging from 0 to 10, at 6 hours, 24 hours, and 7 days postoperatively. The VAS is a tool used to help a person assess the intensity of certain sensations and feelings, such as pain. It consists of a straight line where one end represents the absence of pain, and the other end represents the worst imaginable pain. The patient marks a point on the line that corresponds to the amount of pain they feel in their shoulders.
Exercise Routine:
Two groups will be formed for the exercise routine:
- Shoulder Exercises Operational Definition:
- Lift the shoulders as high as possible toward the ears.
- Maintain this position for 3 seconds.
- Rest.
- Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital ward.
- Suspend during the night.
- Hand Exercises
Operational Definition:
- Open and close the hands, making a fist and applying force.
- Maintain this position for 3 seconds.
- Rest.
- Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital ward.
- Suspend during the night.
Control Variables:
- Visceral Pain Control Operational Definition:
- Visceral pain (not at the surgical incision site) referred by the patient on a Visual Analog Scale (VAS) ranging from 0 to 10, at 6 hours, 24 hours, and 7 days postoperatively. The VAS is a tool used to help a person assess the intensity of certain sensations and feelings, such as pain. It consists of a straight line where one end represents the absence of pain, and the other end represents the worst imaginable pain. The patient marks a point on the line that corresponds to the amount of pain they feel.
- Incisional Pain Control
Operational Definition:
- Pain at the surgical incision site referred by the patient on a Visual Analog Scale (VAS) ranging from 0 to 10, at 6 hours, 24 hours, and 7 days postoperatively. The VAS is a tool used to help a person assess the intensity of certain sensations and feelings, such as pain. It consists of a straight line where one end represents the absence of pain, and the other end represents the worst imaginable pain. The patient marks a point on the line that corresponds to the amount of pain they feel
Control Variables:
- Duration of Neumoperitoneum Operational Definition:
- Time in minutes of the duration of CO2 insufflation during the surgical event.
- Average Neumoperitoneum Pressure Operational Definition:
- Average pressure in millimeters of mercury (mm Hg) of CO2 used during the surgical procedure.
- Use of Intravenous Analgesics in Immediate Postoperative Period Operational Definition:
- Use of intravenous analgesics in the immediate postoperative period. This variable includes specific analgesics administered and their administration schedule.
- Rescue Analgesic in Postoperative Period Operational Definition:
- Use of an additional intravenous analgesic for uncontrolled pain in the immediate postoperative period.
- Surgical Drainage Operational Definition:
- Placement of any type of negative pressure drainage in the abdominal cavity.
- Age Operational Definition:
- The age of the patient in years.
- Body Mass Index (BMI) Operational Definition:
- BMI is a measure of the association between a person's weight and height, calculated as weight in kilograms divided by height in square meters. Control Variables (Continued):
- Comorbidities
Operational Definition:
- Existence of a chronic disease in the patient at the time of surgery. This variable includes specific chronic diseases such as hypertension, diabetes, kidney disease, cardiovascular disease, psychiatric conditions, lung disease, immunosuppression, chronic pain syndrome, and other chronic diseases.
- Chronic Pain Syndrome
Operational Definition:
- Presence of chronic pain that can range from mild to severe and persists or evolves for a long period of time (3 months or more).
- Treatment with Psychotropic Drugs
Operational Definition:
- Use of medications for the treatment of mental illnesses or alterations of the psychic sphere.
- Depression
Operational Definition:
- Assessed using a self-administered questionnaire with 14 items, divided into two subscales of seven items each: one for anxiety (odd-numbered items) and one for depression (even-numbered items). Responses are scored on a Likert scale ranging from 0 to 3, resulting in a minimum score of 0 and a maximum score of 21 for each subscale. Based on the scale, it is determined if the person has symptoms of anxiety or depression, to what extent, and whether it constitutes a clinical diagnosis. The scale is validated in Mexico.
- Anxiety
Operational Definition:
- Assessed using the same questionnaire as for depression (15), with a Likert scale ranging from 0 to 3. The presence and level of anxiety symptoms are determined based on the scores.
- Surgeon
Operational Definition:
- The gynecologist trained in gynecological endoscopic surgery who performs the total laparoscopic hysterectomy at the National Institute of Perinatology. The study includes various surgeons who perform these procedures.
- Bleeding
Operational Definition:
- Blood loss during the surgical procedure, measured in milliliters (mL).
- Adherence to Exercises
Operational Definition:
- Adherence to the exercise routine, measured as a percentage of exercises completed during the hospitalization.
T A) Independent Variable: Exercise Routine, Two Groups will be Formed
- Shoulder Exercises Operational Definition: Lift the shoulders as high as possible towards the ears, hold for 3 seconds, and rest. Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital floor. Suspend during the night.
- Hand Exercises Operational Definition: Open and close the hands while making a fist, hold for 3 seconds, and rest. Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital floor.
- Dependent Variable: Shoulder Pain Reported by the Patient on a Visual Analog Scale (VAS) from 0 to 10, at 6 hours, 24 hours, and 7 days post-surgery.
- Type of Variable: Quantitative Continuous
- Measurement Level: 0-10
- Control Variables: Bleeding, Surgeon, Anxiety, Depression, Treatment with Psychotropic Drugs, Chronic Pain Syndrome, Comorbidities, Body Mass Index, Age, Surgical Drainage, Rescue Analgesic Use, Standard Analgesic Regimen, CO2 Insufflation Pressure, Duration of Pneumoperitoneum
.
- Independent Variable: Exercise Routine, Two Groups will be Formed
- Shoulder Exercises Operational Definition: Lift the shoulders as high as possible towards the ears, hold for 3 seconds, and rest. Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital floor. Suspend during the night.
- Hand Exercises Operational Definition: Open and close the hands while making a fist, hold for 3 seconds, and rest. Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital floor.
- Dependent Variable: Shoulder Pain Reported by the Patient on a Visual Analog Scale (VAS) from 0 to 10, at 6 hours, 24 hours, and 7 days post-surgery.
- Type of Variable: Quantitative Continuous
- Measurement Level: 0-10
- Control Variables: Bleeding, Surgeon, Anxiety, Depression, Treatment with Psychotropic Drugs, Chronic Pain Syndrome, Comorbidities, Body Mass Index, Age, Surgical Drainage, Rescue Analgesic Use, Standard Analgesic Regimen, CO2 Insufflation Pressure, Duration of Pneumoperitoneum
- Being tested
- Shoulder exercises, Hand exercises
- Keywords
- LAPAROSCOPIC HYSTERECTOMY, SHOULDER PAIN, EXERCISE, POSTOPERATIVE PAIN
- Medical subject headings
- Pain, Postoperative, Shoulder Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder exercisesOther
Operational Definition:
- Lift the shoulders as high as possible toward the ears.
- Maintain this position for 3 seconds.
- Rest.
- Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital ward.
- Suspend during the night.
Hand exercisesOther
Operational Definition:
- Open and close the hands, making a fist and applying force.
- Maintain this position for 3 seconds.
- Rest.
- Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital ward.
- Suspend during the night.
| Study group | Role | What they receive |
|---|---|---|
| SHOULDER EXERCISES | Experimental | Patients randomized to the exercise routine group will be instructed, upon recovery, about the exercise routine. The routine consists of lifting the shoulders as high as possible towards the ears, holding for 3 seconds, and then resting. This should be repeated 10 times at the beginning of each hour during the immediate postoperative period while on the hospital ward. The routine will be suspended at night. The procedure will be standardized, as the principal investigators will personally explain and demonstrate it to all involved individuals who are responsible for explaining it to the patients. In-person reminders will be made, and pain in the shoulders, incisions, and abdomen will be recorded at 6 hours and 24 hours postoperatively, as well as during the follow-up consultations on day post-surgery Receives: Other: Shoulder exercises |
| HAND EXERCISES | Sham comparator | Patients randomized to the exercise routine group will be instructed, upon recovery, about the exercise routine. The sham routine consists of tightly opening and closing the hands, holding for 3 seconds, and then resting. This should be repeated 10 times at the beginning of each hour during the immediate postoperative period while on the hospital ward. The routine will be suspended at night. The procedure will be standardized, as the principal investigator will personally explain and demonstrate it to all individuals responsible for instructing the patients. In-person reminders will be issued, and pain in the shoulders, incisions, and abdomen will be recorded at 6 hours and 24 hours postoperatively, as well as during the follow-up consultations on the 7th day after surgery. Receives: Other: Hand exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder pain
Shoulder pain referred by the patient on a Visual Analog Scale (VAS) ranging from 0 to 10. The VAS is a tool used to help a person assess the intensity of certain sensations and feelings, such as pain. It consists of a straight line where one end represents the absence of pain, and the other end represents the worst imaginable pain. The patient marks a point on the line that corresponds to the amount of pain they feel in their shoulders.
Measured: 6 hours, 24 hours, and 7 days postoperatively
Secondary outcomes (2)
Visceral Pain
Visceral pain referred by the patient on a Visual Analog Scale (VAS) ranging from 0 to 10. The VAS is a tool used to help a person assess the intensity of certain sensations and feelings, such as pain. It consists of a straight line where one end represents the absence of pain, and the other end represents the worst imaginable pain. The patient marks a point on the line that corresponds to the amount of pain they feel in the abdomen (not in the incisions).
Measured: 6 hours, 24 hours, and 7 days postoperatively
Incisional Pain
Incisional pain referred by the patient on a Visual Analog Scale (VAS) ranging from 0 to 10. The VAS is a tool used to help a person assess the intensity of certain sensations and feelings, such as pain. It consists of a straight line where one end represents the absence of pain, and the other end represents the worst imaginable pain. The patient marks a point on the line that corresponds to the amount of pain they feel in the incisions.
Measured: 6 hours, 24 hours, and 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start20 Jan 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Andrea Alicia Olguin Ortega, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195176
- Sponsor's protocol ID
- 2022-1-40
- Acronym
- ERPOSP
- Status last verified
- Apr 2024
- First submitted
- 22 Dec 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Yang SC, Chang KY, Wei LF, Shyr YM, Ho CM. To drain or not to drain: the association between residual intraperitoneal gas and post-laparoscopic shoulder pain for laparoscopic cholecystectomy. Sci Rep. 2021 Jun 1;11(1):7447. doi: 10.1038/s41598-021-85714-4.
PubMed 34059697Lee DH, Song T, Kim KH, Lee KW. Incidence, natural course, and characteristics of postlaparoscopic shoulder pain. Surg Endosc. 2018 Jan;32(1):160-165. doi: 10.1007/s00464-017-5651-5. Epub 2017 Jun 22.
PubMed 28643053Wada S, Fukushi Y, Nishimura M, Matsumoto S, Takimoto K, Imai K, Ota H, Tsuzuki Y, Nakajima A, Fujino T. Analysis of risk factors of postlaparoscopic shoulder pain. J Obstet Gynaecol Res. 2020 Feb;46(2):310-313. doi: 10.1111/jog.14156. Epub 2020 Jan 20.
PubMed 31958892van Dijk J, Dedden SJ, Geomini P, van Kuijk S, van Hanegem N, Meijer P, Bongers MY. Randomised controlled trial to estimate reduction in pain after laparoscopic surgery when using a combination therapy of intraperitoneal normal saline and the pulmonary recruitment manoeuvre. BJOG. 2018 Oct;125(11):1469-1476. doi: 10.1111/1471-0528.15207. Epub 2018 Apr 15.
PubMed 29498786Reeve J, Stiller K, Nicol K, McPherson KM, Birch P, Gordon IR, Denehy L. A postoperative shoulder exercise program improves function and decreases pain following open thoracotomy: a randomised trial. J Physiother. 2010;56(4):245-52. doi: 10.1016/s1836-9553(10)70007-2.
PubMed 21091414Klein I, Kalichman L, Chen N, Susmallian S. A pilot study evaluating the effect of early physical therapy on pain and disabilities after breast cancer surgery: Prospective randomized control trail. Breast. 2021 Oct;59:286-293. doi: 10.1016/j.breast.2021.07.013. Epub 2021 Jul 21.
PubMed 34340163Tanner TN, Hall BR, Oran J. Pneumoperitoneum. Surg Clin North Am. 2018 Oct;98(5):915-932. doi: 10.1016/j.suc.2018.06.004.
PubMed 30243453Yamamoto-Furusho JK, Sarmiento-Aguilar A, Garcia-Alanis M, Gomez-Garcia LE, Toledo-Maurino J, Olivares-Guzman L, Fresan-Orellana A. Hospital Anxiety and Depression Scale (HADS): Validation in Mexican Patients with Inflammatory Bowel Disease. Gastroenterol Hepatol. 2018 Oct;41(8):477-482. doi: 10.1016/j.gastrohep.2018.05.009. Epub 2018 Jun 21. English, Spanish.
PubMed 29937084Bastamizad N, Abbasi P, Salari N, Jalali R. Comparing the Effect of Incentive Spirometry and Deep Breathing Exercises on the Level of Shoulder Pain and Nausea Following Laparoscopic Cholecystectomy Surgery: A Clinical Trial Study. Gastroenterol Nurs. 2023 Jan-Feb 01;46(1):14-22. doi: 10.1097/SGA.0000000000000720. Epub 2023 Jan 10.
PubMed 36706138Zeeni C, Chamsy D, Khalil A, Abu Musa A, Al Hassanieh M, Shebbo F, Nassif J. Effect of postoperative Trendelenburg position on shoulder pain after gynecological laparoscopic procedures: a randomized clinical trial. BMC Anesthesiol. 2020 Jan 29;20(1):27. doi: 10.1186/s12871-020-0946-9.
PubMed 31996139Choi JB, Kang K, Song MK, Seok S, Kim YH, Kim JE. Pain Characteristics after Total Laparoscopic Hysterectomy. Int J Med Sci. 2016 Jul 5;13(8):562-8. doi: 10.7150/ijms.15875. eCollection 2016.
PubMed 27499688
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial: Effect of an Exercise Routine on Postoperative Shoulder Pain in Total Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT06195176
- Acronym / sponsor ID
- ERPOSP / 2022-1-40
- Keywords
- LAPAROSCOPIC HYSTERECTOMY, SHOULDER PAIN, EXERCISE, POSTOPERATIVE PAIN
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los ReyesOther government
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a clinical trial aimed at understanding the impact of a shoulder exercise routine on postoperative shoulder pain in patients who have undergone laparoscopic hysterectomy.
Main Questions:
- Does implementing a shoulder exercise routine immediately after laparoscopic hysterectomy reduce postoperative shoulder pain?
Brief Explanation: We want to see if doing shoulder exercises right after laparoscopic hysterectomy can help reduce the pain they might feel in their shoulders. This kind of pain can happen because of the gas used during the surgery. Using exercises could be a cost-effective and easy way to help patients recover better after the surgery.
Hypothesis: We think that doing shoulder exercises right after laparoscopic hysterectomy will lower the amount of shoulder pain patients experience after the surgery.
Objective: Our goal is to find out if a shoulder exercise routine can make a difference in how much shoulder pain patients have right after laparoscopic hysterectomy.
How We'll Do It: This study aims to evaluate the impact of a shoulder exercise routine on reducing postoperative shoulder pain in women who have undergone total laparoscopic hysterectomy at the National Institute of Perinatology. Recognizing the high prevalence and intensity of post-laparoscopy shoulder pain, the study compares the effectiveness of shoulder exercises to hand exercises in managing this pain. Patients, selected based on specific inclusion and exclusion criteria, will be randomly assigned to either the shoulder or hand exercise group. The exercise regimen involves performing specific movements at regular intervals during the immediate postoperative period, except at night. Pain intensity will be measured using a Visual Analog Scale at various intervals postoperatively. The study controls for several variables, including visceral and incisional pain, duration of pneumoperitoneum, analgesic use, and patient characteristics like BMI and comorbidities, to ensure a comprehensive understanding of the exercises' effectiveness. The hypothesis tests whether shoulder exercises can reduce shoulder pain more effectively than hand exercises. This research could have significant implications for enhancing recovery and pain management strategies post-laparoscopy.
Detailed description
Main Objective
To evaluate the effect of a shoulder exercise routine versus a hand exercise routine on the intensity of shoulder pain in women postoperatively following total laparoscopic hysterectomy at the National Institute of Perinatology
Specific Objectives:
- Describe the frequency and intensity of shoulder pain in women postoperatively following total laparoscopic hysterectomy.
- Determine the effect of the shoulder exercise routine versus a hand exercise routine on the intensity of shoulder pain in women postoperatively following total laparoscopic hysterectomy.
- Evaluate the adjusted effect of the proposed intervention on pain after identifying potential confounding variables. Postoperative management will be similar in both intervention groups, so we do not expect to make adjustments. In the event that confounding variables are identified, we will address them accordingly.
Hypothesis:
H0 (Null Hypothesis): Shoulder exercises in the postoperative period do not reduce shoulder pain by at least one point on the Visual Analog Scale compared to a hand exercise routine.
Description of the Procedure
Only patients scheduled for surgery at 8:00 AM will be considered to ensure that the exercise routine has a consistent duration for all patients during the postoperative period. Inclusion criteria involve patients receiving mixed anesthesia, and all patients will be positioned on the surgical table with shoulder pads and a hip angulation of 15 degrees with inflatable leg supports. Patients with negative pressure drains will be excluded from the study. The principal investigator will be blinded to the randomization group, and patient assessments will be conducted by another investigator.
Once a patient agrees to participate in the project and signs the informed consent authorization, they will be randomized into one of the treatment groups. Randomization will be done using opaque, sealed envelopes contained in a box. Each envelope will specify the assigned intervention group. An equal number of envelopes for both intervention groups will be prepared in advance and shuffled. Patients will choose an envelope. The box with envelopes will be safeguarded by the principal investigator using a simple randomization method generated by envelopes from an Excel-generated number table, distributed in sets of 8 until reaching the total of 112 patients.
Patients randomized to the exercise routine group will be instructed, upon recovery, about the exercise routine. The routine consists of lifting the shoulders as high as possible towards the ears, holding for 3 seconds, and then resting. This should be repeated 10 times at the beginning of each hour during the immediate postoperative period while on the hospital ward. The routine will be suspended during the night. The procedure will be standardized, as the principal investigator will personally explain and demonstrate it to all involved individuals who are responsible for explaining it to the patients. Telephone and in-person reminders will be made, and pain in the shoulders, incisions, and perineum will be recorded upon leaving the recovery room, at 6 hours and 24 hours postoperatively, as well as during the follow-up consultations on day 7 and day 30 post-surgery.
A data recording sheet with a visual analog scale from 0 to 10, representing the pain graphically, will be used to document pain levels upon leaving recovery, at 6 and 24 hours postoperatively, along with the time and dosage of analgesics and any rescue analgesics used. Additionally, patient adherence to the exercise routine will be recorded, allowing them to document their hospitalization days and the hours of the day when they perform the exercises.
Population: Patients postoperatively following uncomplicated total laparoscopic hysterectomy for benign conditions in the Department of Gynecology at INPer (National Institute of Perinatology).
Sample Type: Random consecutive cases, generated using a random number table in Excel.
Sample Size: Calculated using a formula for the difference in means of independent samples, considering a reported Visual Analog Scale (VAS) taing into account an VAS score reported at 6 hours postoperative witha mean in the experimental group of 3.0 (SD +-2.0) and the control group of 4.5 (SD +2.0) with a two tailed hypothesis, and statistical power 80% and an alphe error of 0.05% the sudy requiered a sample size of 28 per group plus 15% of possible dropout rate, the result is 33 patients per group and 66 in the total sample.
Sampling Type: Random consecutive cases.
Definition of Units of Observation: Patients postoperatively following uncomplicated total laparoscopic hysterectomy in the Department of Gynecology at INPer.
Definition of Control Group: Patients postoperatively following uncomplicated total laparoscopic hysterectomy in the Department of Gynecology at INPer, randomized to the control group, which will perform a series of hand exercises.
Inclusion Criteria:
- Patients undergoing uncomplicated total laparoscopic hysterectomy at INPer for benign pathology.
- Mixed anesthesia.
- Placement of shoulder pads on the surgical table during surgery.
- Adults who agree to participate and sign informed consent.
Exclusion Criteria:
- Patients with preoperative shoulder pain.
- Patients who had intraabdominal CO2 pressure greater than 15 mm Hg during surgery.
- Patients who received a postoperative analgesia pump.
- Patients participating in another protocol.
Elimination Criteria:
- Patients with postoperative complications requiring reoperation or Intensive Care Unit admission x Dependent Variable:
Shoulder pain referred by the patient on a Visual Analog Scale (VAS) ranging from 0 to 10, at 6 hours, 24 hours, and 7 days postoperatively. The VAS is a tool used to help a person assess the intensity of certain sensations and feelings, such as pain. It consists of a straight line where one end represents the absence of pain, and the other end represents the worst imaginable pain. The patient marks a point on the line that corresponds to the amount of pain they feel in their shoulders.
Exercise Routine:
Two groups will be formed for the exercise routine:
- Shoulder Exercises Operational Definition:
- Lift the shoulders as high as possible toward the ears.
- Maintain this position for 3 seconds.
- Rest.
- Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital ward.
- Suspend during the night.
- Hand Exercises
Operational Definition:
- Open and close the hands, making a fist and applying force.
- Maintain this position for 3 seconds.
- Rest.
- Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital ward.
- Suspend during the night.
Control Variables:
- Visceral Pain Control Operational Definition:
- Visceral pain (not at the surgical incision site) referred by the patient on a Visual Analog Scale (VAS) ranging from 0 to 10, at 6 hours, 24 hours, and 7 days postoperatively. The VAS is a tool used to help a person assess the intensity of certain sensations and feelings, such as pain. It consists of a straight line where one end represents the absence of pain, and the other end represents the worst imaginable pain. The patient marks a point on the line that corresponds to the amount of pain they feel.
- Incisional Pain Control
Operational Definition:
- Pain at the surgical incision site referred by the patient on a Visual Analog Scale (VAS) ranging from 0 to 10, at 6 hours, 24 hours, and 7 days postoperatively. The VAS is a tool used to help a person assess the intensity of certain sensations and feelings, such as pain. It consists of a straight line where one end represents the absence of pain, and the other end represents the worst imaginable pain. The patient marks a point on the line that corresponds to the amount of pain they feel
Control Variables:
- Duration of Neumoperitoneum Operational Definition:
- Time in minutes of the duration of CO2 insufflation during the surgical event.
- Average Neumoperitoneum Pressure Operational Definition:
- Average pressure in millimeters of mercury (mm Hg) of CO2 used during the surgical procedure.
- Use of Intravenous Analgesics in Immediate Postoperative Period Operational Definition:
- Use of intravenous analgesics in the immediate postoperative period. This variable includes specific analgesics administered and their administration schedule.
- Rescue Analgesic in Postoperative Period Operational Definition:
- Use of an additional intravenous analgesic for uncontrolled pain in the immediate postoperative period.
- Surgical Drainage Operational Definition:
- Placement of any type of negative pressure drainage in the abdominal cavity.
- Age Operational Definition:
- The age of the patient in years.
- Body Mass Index (BMI) Operational Definition:
- BMI is a measure of the association between a person's weight and height, calculated as weight in kilograms divided by height in square meters. Control Variables (Continued):
- Comorbidities
Operational Definition:
- Existence of a chronic disease in the patient at the time of surgery. This variable includes specific chronic diseases such as hypertension, diabetes, kidney disease, cardiovascular disease, psychiatric conditions, lung disease, immunosuppression, chronic pain syndrome, and other chronic diseases.
- Chronic Pain Syndrome
Operational Definition:
- Presence of chronic pain that can range from mild to severe and persists or evolves for a long period of time (3 months or more).
- Treatment with Psychotropic Drugs
Operational Definition:
- Use of medications for the treatment of mental illnesses or alterations of the psychic sphere.
- Depression
Operational Definition:
- Assessed using a self-administered questionnaire with 14 items, divided into two subscales of seven items each: one for anxiety (odd-numbered items) and one for depression (even-numbered items). Responses are scored on a Likert scale ranging from 0 to 3, resulting in a minimum score of 0 and a maximum score of 21 for each subscale. Based on the scale, it is determined if the person has symptoms of anxiety or depression, to what extent, and whether it constitutes a clinical diagnosis. The scale is validated in Mexico.
- Anxiety
Operational Definition:
- Assessed using the same questionnaire as for depression (15), with a Likert scale ranging from 0 to 3. The presence and level of anxiety symptoms are determined based on the scores.
- Surgeon
Operational Definition:
- The gynecologist trained in gynecological endoscopic surgery who performs the total laparoscopic hysterectomy at the National Institute of Perinatology. The study includes various surgeons who perform these procedures.
- Bleeding
Operational Definition:
- Blood loss during the surgical procedure, measured in milliliters (mL).
- Adherence to Exercises
Operational Definition:
- Adherence to the exercise routine, measured as a percentage of exercises completed during the hospitalization.
T A) Independent Variable: Exercise Routine, Two Groups will be Formed
- Shoulder Exercises Operational Definition: Lift the shoulders as high as possible towards the ears, hold for 3 seconds, and rest. Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital floor. Suspend during the night.
- Hand Exercises Operational Definition: Open and close the hands while making a fist, hold for 3 seconds, and rest. Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital floor.
- Dependent Variable: Shoulder Pain Reported by the Patient on a Visual Analog Scale (VAS) from 0 to 10, at 6 hours, 24 hours, and 7 days post-surgery.
- Type of Variable: Quantitative Continuous
- Measurement Level: 0-10
- Control Variables: Bleeding, Surgeon, Anxiety, Depression, Treatment with Psychotropic Drugs, Chronic Pain Syndrome, Comorbidities, Body Mass Index, Age, Surgical Drainage, Rescue Analgesic Use, Standard Analgesic Regimen, CO2 Insufflation Pressure, Duration of Pneumoperitoneum
.
- Independent Variable: Exercise Routine, Two Groups will be Formed
- Shoulder Exercises Operational Definition: Lift the shoulders as high as possible towards the ears, hold for 3 seconds, and rest. Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital floor. Suspend during the night.
- Hand Exercises Operational Definition: Open and close the hands while making a fist, hold for 3 seconds, and rest. Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital floor.
- Dependent Variable: Shoulder Pain Reported by the Patient on a Visual Analog Scale (VAS) from 0 to 10, at 6 hours, 24 hours, and 7 days post-surgery.
- Type of Variable: Quantitative Continuous
- Measurement Level: 0-10
- Control Variables: Bleeding, Surgeon, Anxiety, Depression, Treatment with Psychotropic Drugs, Chronic Pain Syndrome, Comorbidities, Body Mass Index, Age, Surgical Drainage, Rescue Analgesic Use, Standard Analgesic Regimen, CO2 Insufflation Pressure, Duration of Pneumoperitoneum
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHOULDER EXERCISES | Experimental | Other: Shoulder exercisesPatients randomized to the exercise routine group will be instructed, upon recovery, about the exercise routine. The routine consists of lifting the shoulders as high as possible towards the ears, holding for 3 seconds, and then resting. This should be repeated 10 times at the beginning of each hour during the immediate postoperative period while on the hospital ward. The routine will be suspended at night. The procedure will be standardized, as the principal investigators will personally explain and demonstrate it to all involved individuals who are responsible for explaining it to the patients. In-person reminders will be made, and pain in the shoulders, incisions, and abdomen will be recorded at 6 hours and 24 hours postoperatively, as well as during the follow-up consultations on day post-surgery |
| HAND EXERCISES | Sham comparator | Other: Hand exercisesPatients randomized to the exercise routine group will be instructed, upon recovery, about the exercise routine. The sham routine consists of tightly opening and closing the hands, holding for 3 seconds, and then resting. This should be repeated 10 times at the beginning of each hour during the immediate postoperative period while on the hospital ward. The routine will be suspended at night. The procedure will be standardized, as the principal investigator will personally explain and demonstrate it to all individuals responsible for instructing the patients. In-person reminders will be issued, and pain in the shoulders, incisions, and abdomen will be recorded at 6 hours and 24 hours postoperatively, as well as during the follow-up consultations on the 7th day after surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing uncomplicated total laparoscopic hysterectomy at INPer for benign pathology.
- Mixed anesthesia.
- Placement of shoulder pads on the surgical table during surgery.
- Adults who agree to participate and sign informed consent.
Key exclusion criteria (4 listed)
- Patients with preoperative shoulder pain.
- Patients who had intraabdominal CO2 pressure greater than 15 mm Hg during surgery.
- Patients who received a postoperative analgesia pump.
- Patients participating in another protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shoulder exercisesOperational Definition: * Lift the shoulders as high as possible toward the ears. * Maintain this position for 3 seconds. * Rest. * Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital ward. * Suspend during the night. | Other | SHOULDER EXERCISES |
| Hand exercisesOperational Definition: * Open and close the hands, making a fist and applying force. * Maintain this position for 3 seconds. * Rest. * Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital ward. * Suspend during the night. | Other | HAND EXERCISES |
Primary outcome
Shoulder pain
Time frame: 6 hours, 24 hours, and 7 days postoperatively
Shoulder pain referred by the patient on a Visual Analog Scale (VAS) ranging from 0 to 10. The VAS is a tool used to help a person assess the intensity of certain sensations and feelings, such as pain. It consists of a straight line where one end represents the absence of pain, and the other end represents the worst imaginable pain. The patient marks a point on the line that corresponds to the amount of pain they feel in their shoulders.
2 secondary outcomes
Visceral Pain
Time frame: 6 hours, 24 hours, and 7 days postoperatively
Incisional Pain
Time frame: 6 hours, 24 hours, and 7 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 34059697Yang SC, Chang KY, Wei LF, Shyr YM, Ho CM. To drain or not to drain: the association between residual intraperitoneal gas and post-laparoscopic shoulder pain for laparoscopic cholecystectomy. Sci Rep. 2021 Jun 1;11(1):7447. doi: 10.1038/s41598-021-85714-4.
- Background: PubMed 28643053Lee DH, Song T, Kim KH, Lee KW. Incidence, natural course, and characteristics of postlaparoscopic shoulder pain. Surg Endosc. 2018 Jan;32(1):160-165. doi: 10.1007/s00464-017-5651-5. Epub 2017 Jun 22.
- Background: PubMed 31958892Wada S, Fukushi Y, Nishimura M, Matsumoto S, Takimoto K, Imai K, Ota H, Tsuzuki Y, Nakajima A, Fujino T. Analysis of risk factors of postlaparoscopic shoulder pain. J Obstet Gynaecol Res. 2020 Feb;46(2):310-313. doi: 10.1111/jog.14156. Epub 2020 Jan 20.
- Background: PubMed 29498786van Dijk J, Dedden SJ, Geomini P, van Kuijk S, van Hanegem N, Meijer P, Bongers MY. Randomised controlled trial to estimate reduction in pain after laparoscopic surgery when using a combination therapy of intraperitoneal normal saline and the pulmonary recruitment manoeuvre. BJOG. 2018 Oct;125(11):1469-1476. doi: 10.1111/1471-0528.15207. Epub 2018 Apr 15.
- Background: PubMed 21091414Reeve J, Stiller K, Nicol K, McPherson KM, Birch P, Gordon IR, Denehy L. A postoperative shoulder exercise program improves function and decreases pain following open thoracotomy: a randomised trial. J Physiother. 2010;56(4):245-52. doi: 10.1016/s1836-9553(10)70007-2.
- Background: PubMed 34340163Klein I, Kalichman L, Chen N, Susmallian S. A pilot study evaluating the effect of early physical therapy on pain and disabilities after breast cancer surgery: Prospective randomized control trail. Breast. 2021 Oct;59:286-293. doi: 10.1016/j.breast.2021.07.013. Epub 2021 Jul 21.
- Background: PubMed 30243453Tanner TN, Hall BR, Oran J. Pneumoperitoneum. Surg Clin North Am. 2018 Oct;98(5):915-932. doi: 10.1016/j.suc.2018.06.004.
- Background: PubMed 29937084Yamamoto-Furusho JK, Sarmiento-Aguilar A, Garcia-Alanis M, Gomez-Garcia LE, Toledo-Maurino J, Olivares-Guzman L, Fresan-Orellana A. Hospital Anxiety and Depression Scale (HADS): Validation in Mexican Patients with Inflammatory Bowel Disease. Gastroenterol Hepatol. 2018 Oct;41(8):477-482. doi: 10.1016/j.gastrohep.2018.05.009. Epub 2018 Jun 21. English, Spanish.
- Background: PubMed 36706138Bastamizad N, Abbasi P, Salari N, Jalali R. Comparing the Effect of Incentive Spirometry and Deep Breathing Exercises on the Level of Shoulder Pain and Nausea Following Laparoscopic Cholecystectomy Surgery: A Clinical Trial Study. Gastroenterol Nurs. 2023 Jan-Feb 01;46(1):14-22. doi: 10.1097/SGA.0000000000000720. Epub 2023 Jan 10.
- Background: PubMed 31996139Zeeni C, Chamsy D, Khalil A, Abu Musa A, Al Hassanieh M, Shebbo F, Nassif J. Effect of postoperative Trendelenburg position on shoulder pain after gynecological laparoscopic procedures: a randomized clinical trial. BMC Anesthesiol. 2020 Jan 29;20(1):27. doi: 10.1186/s12871-020-0946-9.
- Results publication: PubMed 27499688Choi JB, Kang K, Song MK, Seok S, Kim YH, Kim JE. Pain Characteristics after Total Laparoscopic Hysterectomy. Int J Med Sci. 2016 Jul 5;13(8):562-8. doi: 10.7150/ijms.15875. eCollection 2016.
- Individual participant dataSharing planned: Yes
Related trials for Postoperative Pain
Recruiting
US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy
Postoperative Pain
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Recruiting
Tramadol Versus Morphine for Postoperative Pain Relief Following Laparoscopic Abdominal Surgery
Multimodal Analgesia, Tramadol
Recruiting
TEAS Timing for Gastrectomy Recovery (TEAS-TIME Trial)
Gastric Cancer (GC), Stomach Neoplasms
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder exercises and Hand exercises in people with Postoperative Pain and Laparoscopic Hysterectomy for Benign Conditions, run by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANDREA A OLGUIN-ORTEGA, MD (+5255209900 ext. 397, olguin.andrea@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder pain (time frame: 6 hours, 24 hours, and 7 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06195176, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.