Shoulder PainNCT04129385
Post Laparoscopy Shoulder Pain and Postoperative Trendelenburg Position
A study testing 20 degree Trendelenburg position in people with Shoulder Pain, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
Laparoscopic surgery has become a standard of care for many gynecological surgeries due to its lower morbidity, pain and cost compared to open techniques. Unfortunately, the use of carbon dioxide (CO2) to insufflate the abdomen is a major contributor to post operative shoulder pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- 20 degree Trendelenburg position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Mar 2016to 28 Jun 2018
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients
- Age: 18 years to 60 years, American Society of Anesthesiologist physical status (ASA) 1 or 2
- Diagnostic or operative gynecologic laparoscopy {4 port sites, three 5 mm trocars (suprapubic, right and left iliac fossa) and one 10 mm trocar (umbilical)} between one and 3 hours duration.
- Abdominal incisions less than 1.5 cm.
- Steady abdominal insufflation pressure of 14 mm Hg following a gradual insufflation over a 5-minute period.
- Insufflation at a steady maximal flow of 30 l/min
Who cannot join
- Conversion to laparotomy.
- Abdominal insufflation pressure more than 14 mm Hg.
- Medical drug allergy to paracetamol, ketoprofen and/or tramadol.
- Presence of gastro-esophageal reflux (GERD)
- Pregnancy
- Patient with Thrombophilias and or at high risk of Deep Vein Thrombosis (DVT)
- Obesity body mass index (BMI) greater than 40
- One day surgery patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Postoperative Trendelenburg Position on Shoulder Pain After Gynecological Laparoscopic Procedures.
Laparoscopic surgery has become a standard of care for many gynecological surgeries due to its lower morbidity, pain and cost compared to open techniques. Unfortunately, the use of carbon dioxide (CO2) to insufflate the abdomen is a major contributor to post operative shoulder pain. Shoulder pain post laparoscopy is common and it is a major cause of patient dissatisfaction. The aim of our study is to evaluate the efficacy of positioning the patient in Trendelenburg, post operatively for 24 hours, on shoulder pain reduction. Our hypothesis is based on the assumption that complete CO2 deflation is not possible and that Trendelenburg positioning will help displace CO2 from the sub diaphragmatic area thus reducing the diaphragmatic and phrenic nerve irritation causing pain.
Read the detailed description
A prospective randomized controlled study with 54 patients in each of the two arms. Group S (control) will undergo the standard laparoscopic procedure and the patients will be placed in supine head up position postoperatively. In group T (interventional); the patients will be positioned in Trendelenburg position once fully awake and cooperative in the post-anesthesia case unit (PACU) and will remain in this position for the first 24 hours postoperatively. Postoperative NRS(numeric rating scale) score for shoulder pain and nausea will be collected at arrival to PACU, \& 4, 6, 12 and 24 hours postoperatively. In addition, total amount of rescue pain and nausea medication used by the patient will be recorded. Data collected will be analyzed and compared between the two groups. The independent t- test will be used to compare postoperative shoulder pain, with NRS scores treated as continuous variable, between the two groups.
- Conditions
- Shoulder Pain
- Being tested
- 20 degree Trendelenburg position
- Keywords
- laparoscopy, shoulder pain, trendelenburg position
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 degree Trendelenburg positionProcedure or surgery
The patients in the intervention group will be placed in trendelenburg position postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Group S | No intervention | Control group (Group S: 54 patients); this group will undergo the standard laparoscopic procedure (the procedure is done in Trendelenburg position). While in Trendelenburg position and prior to wound closure and with laparoscopic port valves open, the patient's abdomen will be passively deflated. The patients will be placed in supine head up position in the post anesthesia care unit (PACU). |
| Group T | Experimental | Intervention group (Group T: 54 patients); the patients will be subject to the same maneuver as in arm 1 prior to wound closure but will be positioned in a 20 degree Trendelenburg position once fully awake and cooperative in the PACU and will remain in this position for the first 24 hours post operatively, even after they are transferred to their rooms on the American University of Beirut Medical Center (AUBMC) floors. The maximum time allowed in a straight-up position will be three 15-minute intervals over a 24-hour period (the first interval being a clear fluids intake at 12 hours postoperatively). Receives: Procedure: 20 degree Trendelenburg position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder pain (12 hours)
Pain score (measured using a 0-10 numerical scale) at 12 hours
Measured: 12 hours after laparoscopic surgery
Secondary outcomes (6)
Shoulder pain
Pain score (measured using a 0-10 numerical scale)
Measured: at arrival to post anesthesia care unit (PACU), 4, 6, and 24 hours, after laparoscopic surgery
Presence of nausea
Presence or absence of nausea (yes/no)
Measured: at arrival to PACU, 4, 6, 12 and 24 hours, after laparoscopic surgery
Severity of Nausea
Nausea score (measured using a 0-10 numerical scale)
Measured: at arrival to PACU, 4, 6, 12 and 24 hours, after laparoscopic surgery
Rescue pain medication
Time to first rescue pain medication (minutes)
Measured: within first 24 hours after laparoscopic surgery
Total rescue pain medication
Total rescue pain medication during first 24 hours
Measured: within first 24 hours after laparoscopic surgery
Patient satisfaction
Patient satisfaction with surgical experience (measured using a 0-10 numerical scale)
Measured: 24 hours post laparoscopic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start1 Mar 2016
- Primary completion20 Jun 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Shoulder 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Nassif, American University of Beirut Medical Center
- Investigators
- Joseph Nassif, M.D., Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129385
- Sponsor's protocol ID
- AmericanUBMC1
- Status last verified
- Oct 2019
- First submitted
- 28 Jun 2019
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Barnett JC, Hurd WW, Rogers RM Jr, Williams NL, Shapiro SA. Laparoscopic positioning and nerve injuries. J Minim Invasive Gynecol. 2007 Sep-Oct;14(5):664-72; quiz 673. doi: 10.1016/j.jmig.2007.04.008. No abstract available.
PubMed 17848335Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. doi: 10.1093/bja/79.3.369. No abstract available.
PubMed 9389858Madsen MR, Jensen KE. Postoperative pain and nausea after laparoscopic cholecystectomy. Surg Laparosc Endosc. 1992 Dec;2(4):303-5.
PubMed 1341550Coventry DM. Anaesthesia for laparoscopic surgery. J R Coll Surg Edinb. 1995 Jun;40(3):151-60.
PubMed 7616466Korell M, Schmaus F, Strowitzki T, Schneeweiss SG, Hepp H. Pain intensity following laparoscopy. Surg Laparosc Endosc. 1996 Oct;6(5):375-9.
PubMed 8890423Jackson SA, Laurence AS, Hill JC. Does post-laparoscopy pain relate to residual carbon dioxide? Anaesthesia. 1996 May;51(5):485-7. doi: 10.1111/j.1365-2044.1996.tb07798.x.
PubMed 8694166Kojima Y, Yokota S, Ina H. Shoulder pain after gynaecological laparoscopy caused by arm abduction. Eur J Anaesthesiol. 2004 Jul;21(7):578-9. doi: 10.1017/s0265021504267126. No abstract available.
PubMed 15318475Lepner U, Goroshina J, Samarutel J. Postoperative pain relief after laparoscopic cholecystectomy: a randomised prospective double-blind clinical trial. Scand J Surg. 2003;92(2):121-4.
PubMed 12841551Berberoglu M, Dilek ON, Ercan F, Kati I, Ozmen M. The effect of CO2 insufflation rate on the postlaparoscopic shoulder pain. J Laparoendosc Adv Surg Tech A. 1998 Oct;8(5):273-7. doi: 10.1089/lap.1998.8.273.
PubMed 9820719Pergialiotis V, Vlachos DE, Kontzoglou K, Perrea D, Vlachos GD. Pulmonary recruitment maneuver to reduce pain after laparoscopy: a meta-analysis of randomized controlled trials. Surg Endosc. 2015 Aug;29(8):2101-8. doi: 10.1007/s00464-014-3934-7. Epub 2014 Nov 1.
PubMed 25361653Sharami SH, Sharami MB, Abdollahzadeh M, Keyvan A. Randomised clinical trial of the influence of pulmonary recruitment manoeuvre on reducing shoulder pain after laparoscopy. J Obstet Gynaecol. 2010;30(5):505-10. doi: 10.3109/01443611003802313.
PubMed 20604657Nezhat, C. and F. Nezhat, Nezhat's Operative Gynecologic Laparoscopy and Hysteroscopy2008: Cambridge University Press.
Suginami R, Taniguchi F, Suginami H. Prevention of postlaparoscopic shoulder pain by forced evacuation of residual CO(2). JSLS. 2009 Jan-Mar;13(1):56-9.
PubMed 19366542Zeeni 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 31996139
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Postoperative Trendelenburg Position on Shoulder Pain After Gynecological Laparoscopic Procedures.
- ClinicalTrials.gov ID
- NCT04129385
- Acronym / sponsor ID
- AmericanUBMC1
- Conditions
- Shoulder Pain
- Keywords
- laparoscopy, shoulder pain, trendelenburg position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 16 Oct 2019 (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.
Laparoscopic surgery has become a standard of care for many gynecological surgeries due to its lower morbidity, pain and cost compared to open techniques. Unfortunately, the use of carbon dioxide (CO2) to insufflate the abdomen is a major contributor to post operative shoulder pain. Shoulder pain post laparoscopy is common and it is a major cause of patient dissatisfaction. The aim of our study is to evaluate the efficacy of positioning the patient in Trendelenburg, post operatively for 24 hours, on shoulder pain reduction. Our hypothesis is based on the assumption that complete CO2 deflation is not possible and that Trendelenburg positioning will help displace CO2 from the sub diaphragmatic area thus reducing the diaphragmatic and phrenic nerve irritation causing pain.
Detailed description
A prospective randomized controlled study with 54 patients in each of the two arms. Group S (control) will undergo the standard laparoscopic procedure and the patients will be placed in supine head up position postoperatively. In group T (interventional); the patients will be positioned in Trendelenburg position once fully awake and cooperative in the post-anesthesia case unit (PACU) and will remain in this position for the first 24 hours postoperatively. Postoperative NRS(numeric rating scale) score for shoulder pain and nausea will be collected at arrival to PACU, \& 4, 6, 12 and 24 hours postoperatively. In addition, total amount of rescue pain and nausea medication used by the patient will be recorded. Data collected will be analyzed and compared between the two groups. The independent t- test will be used to compare postoperative shoulder pain, with NRS scores treated as continuous variable, between the two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | No intervention | –Control group (Group S: 54 patients); this group will undergo the standard laparoscopic procedure (the procedure is done in Trendelenburg position). While in Trendelenburg position and prior to wound closure and with laparoscopic port valves open, the patient's abdomen will be passively deflated. The patients will be placed in supine head up position in the post anesthesia care unit (PACU). |
| Group T | Experimental | Procedure: 20 degree Trendelenburg positionIntervention group (Group T: 54 patients); the patients will be subject to the same maneuver as in arm 1 prior to wound closure but will be positioned in a 20 degree Trendelenburg position once fully awake and cooperative in the PACU and will remain in this position for the first 24 hours post operatively, even after they are transferred to their rooms on the American University of Beirut Medical Center (AUBMC) floors. The maximum time allowed in a straight-up position will be three 15-minute intervals over a 24-hour period (the first interval being a clear fluids intake at 12 hours postoperatively). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female patients
- Age: 18 years to 60 years, American Society of Anesthesiologist physical status (ASA) 1 or 2
- Diagnostic or operative gynecologic laparoscopy {4 port sites, three 5 mm trocars (suprapubic, right and left iliac fossa) and one 10 mm trocar (umbilical)} between one and 3 hours duration.
- Abdominal incisions less than 1.5 cm.
- Steady abdominal insufflation pressure of 14 mm Hg following a gradual insufflation over a 5-minute period.
Key exclusion criteria (8 listed)
- Conversion to laparotomy.
- Abdominal insufflation pressure more than 14 mm Hg.
- Medical drug allergy to paracetamol, ketoprofen and/or tramadol.
- Presence of gastro-esophageal reflux (GERD)
- Pregnancy
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 |
|---|---|---|
| 20 degree Trendelenburg positionThe patients in the intervention group will be placed in trendelenburg position postoperatively. | Procedure or surgery | Group T |
Primary outcome
Shoulder pain (12 hours)
Time frame: 12 hours after laparoscopic surgery
Pain score (measured using a 0-10 numerical scale) at 12 hours
6 secondary outcomes
Shoulder pain
Time frame: at arrival to post anesthesia care unit (PACU), 4, 6, and 24 hours, after laparoscopic surgery
Presence of nausea
Time frame: at arrival to PACU, 4, 6, 12 and 24 hours, after laparoscopic surgery
Severity of Nausea
Time frame: at arrival to PACU, 4, 6, 12 and 24 hours, after laparoscopic surgery
Rescue pain medication
Time frame: within first 24 hours after laparoscopic surgery
Total rescue pain medication
Time frame: within first 24 hours after laparoscopic surgery
Patient satisfaction
Time frame: 24 hours post laparoscopic surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Background: PubMed 17848335Barnett JC, Hurd WW, Rogers RM Jr, Williams NL, Shapiro SA. Laparoscopic positioning and nerve injuries. J Minim Invasive Gynecol. 2007 Sep-Oct;14(5):664-72; quiz 673. doi: 10.1016/j.jmig.2007.04.008. No abstract available.
- Background: PubMed 9389858Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. doi: 10.1093/bja/79.3.369. No abstract available.
- Background: PubMed 1341550Madsen MR, Jensen KE. Postoperative pain and nausea after laparoscopic cholecystectomy. Surg Laparosc Endosc. 1992 Dec;2(4):303-5.
- Background: PubMed 7616466Coventry DM. Anaesthesia for laparoscopic surgery. J R Coll Surg Edinb. 1995 Jun;40(3):151-60.
- Background: PubMed 8890423Korell M, Schmaus F, Strowitzki T, Schneeweiss SG, Hepp H. Pain intensity following laparoscopy. Surg Laparosc Endosc. 1996 Oct;6(5):375-9.
- Background: PubMed 8694166Jackson SA, Laurence AS, Hill JC. Does post-laparoscopy pain relate to residual carbon dioxide? Anaesthesia. 1996 May;51(5):485-7. doi: 10.1111/j.1365-2044.1996.tb07798.x.
- Background: PubMed 15318475Kojima Y, Yokota S, Ina H. Shoulder pain after gynaecological laparoscopy caused by arm abduction. Eur J Anaesthesiol. 2004 Jul;21(7):578-9. doi: 10.1017/s0265021504267126. No abstract available.
- Background: PubMed 12841551Lepner U, Goroshina J, Samarutel J. Postoperative pain relief after laparoscopic cholecystectomy: a randomised prospective double-blind clinical trial. Scand J Surg. 2003;92(2):121-4.
- Background: PubMed 9820719Berberoglu M, Dilek ON, Ercan F, Kati I, Ozmen M. The effect of CO2 insufflation rate on the postlaparoscopic shoulder pain. J Laparoendosc Adv Surg Tech A. 1998 Oct;8(5):273-7. doi: 10.1089/lap.1998.8.273.
- Background: PubMed 25361653Pergialiotis V, Vlachos DE, Kontzoglou K, Perrea D, Vlachos GD. Pulmonary recruitment maneuver to reduce pain after laparoscopy: a meta-analysis of randomized controlled trials. Surg Endosc. 2015 Aug;29(8):2101-8. doi: 10.1007/s00464-014-3934-7. Epub 2014 Nov 1.
- Background: PubMed 20604657Sharami SH, Sharami MB, Abdollahzadeh M, Keyvan A. Randomised clinical trial of the influence of pulmonary recruitment manoeuvre on reducing shoulder pain after laparoscopy. J Obstet Gynaecol. 2010;30(5):505-10. doi: 10.3109/01443611003802313.
- BackgroundNezhat, C. and F. Nezhat, Nezhat's Operative Gynecologic Laparoscopy and Hysteroscopy2008: Cambridge University Press.
- Individual participant dataSharing planned: No
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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.
Joseph Nassif, M.D. principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20 degree Trendelenburg position in people with Shoulder Pain, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 16 Oct 2019. 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 Lebanon. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder pain (12 hours) (time frame: 12 hours after laparoscopic surgery). 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 NCT04129385, which also lists 14 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 16 Oct 2019.