Shoulder PainNCT05043844
Comparison of the Incidence of Shoulder Pain According to Postoperative Use of Abdominal Binder
A study testing abdominal binder in people with Shoulder Pain, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of the study is to evaluate the effect of the use of an abdominal binder on postoperative shoulder pain according to laparoscopic gynecological surgery. The investigators will compare the incidences of shoulder pain after laparoscopic gynecological surgery in terms of the use of an abdominal binder. Read more about this study
- Who is it for?
- Ages 20 to 79 years, women only
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- abdominal binder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2021to Sep 2022
- 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 20 to 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 20-79 years with ASA I - III undergoing elective laparoscopic gynecological surgery under general anesthesia
Who cannot join
- Patients who do not consent to the trial
- Conversion to open surgery from laparoscopic surgery
- Patients with previous shoulder disease or history of shoulder surgery
- Patients who have difficulty wearing an abdominal binder due to skin disease or wounds in the abdomen
- Development of subcutaneous emphysema
- Change of intra-abdominal carbon dioxide pressure due to surgical difficulties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Abdominal Binder Use on Postoperative Shoulder Pain After Laparoscopic Gynecological Surgery
The aim of the study is to evaluate the effect of the use of an abdominal binder on postoperative shoulder pain according to laparoscopic gynecological surgery. The investigators will compare the incidences of shoulder pain after laparoscopic gynecological surgery in terms of the use of an abdominal binder.
Read the detailed description
Laparoscopic surgery has advantages over laparotomy in that it reduces postoperative pain and hospital stay. However, postoperative shoulder pain is one of the major concerns of laparoscopic surgery. Shoulder pain has been reported to occur in 35 to 70% of laparoscopic surgeries. The exact mechanism of shoulder pain after laparoscopic surgery is not clear. The main hypothesis is that the presence of residual carbon dioxide (CO2) in the abdominal cavity stimulates the diaphragmatic nerve and causes pain in the shoulder. Alveolar recruitment maneuver in the Trendelenburg position reduced the intensity and incidence of shoulder pain significantly. However, even with these measures, shoulder pain occurred in 63% of patients after surgery. In addition to this measure, The investigators hypothesized that wearing an abdominal binder would promote the absorption of residual CO2 in the abdominal cavity into the peritoneum and pelvis pressure.
The aim of this study was to evaluate the effect of the use of an abdominal binder on shoulder pain after gynecological laparoscopic surgery.
The intraoperative management is carried out in the same manner, except for wearing an abdominal binder after surgery. Laparoscopic procedure is completed, and then intraperitoneal CO2 is passive drained. An anesthetist places the operating table in the Trendelenburg position at 30 degrees and performs the alveolar recruitment maneuver. (CPAP 45 cm H2O is administered 5 times for 7 seconds) In the abdominal binder group, the patient wears an abdominal binder in the Trendelenburg position and then changed to the supine position before the emergence.
In the control group, the patient placed in the supine position, and emergence is started.
Shoulder pain at 12, 24, and 36 hours after surgery is investigated with a Numeric Score Scale (NRS) score.
- Conditions
- Shoulder Pain
- Being tested
- abdominal binder
- Keywords
- Laparoscopic Surgery, Gynecology
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal binderDevice
Wearing an abdominal binder postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | In the control group, an investigator performed only a pulmonary recruitment maneuver on the Trendelenburg position before the emergence of anesthesia. |
| Abdominal binder | Experimental | In the abdominal binder group, a pulmonary recruitment maneuver was performed on the Trendelenburg position and the abdominal binder which had a standard height of 22 cm was placed on the abdomen of the patient before the emergence of anesthesia. Receives: Device: abdominal binder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative shoulder pain
Investigate occurrence of postoperative shoulder pain at 12 hours, 24 hours, and 36 hours after surgery. The occurrence of shoulder pain is defined as having NRS ≥ 1 pain at least once out of the three measurement time points.
Measured: Postoperative shoulder pain at 12 hours after surgery
Postoperative shoulder pain
Investigate occurrence of postoperative shoulder pain at 12 hours, 24 hours, and 36 hours after surgery. The occurrence of shoulder pain is defined as having NRS ≥ 1 pain at least once out of the three measurement time points.
Measured: Postoperative shoulder pain at 24 hours after surgery
Postoperative shoulder pain
Investigate occurrence of postoperative shoulder pain at 12 hours, 24 hours, and 36 hours after surgery. The occurrence of shoulder pain is defined as having NRS ≥ 1 pain at least once out of the three measurement time points.
Measured: Postoperative shoulder pain at 36 hours after surgery
Secondary outcomes (5)
Intensity of postoperative shoulder pain
Investigate shoulder pain intensity using numerical rating scale (0-10, 0 representing 'no pain', 10 representing 'worst pain imaginable')
Measured: at 12 hours, 24 hours, and 36 hours after surgery
Shoulder pain depending on posture
Investigate whether there is a change in shoulder pain depending on the posture.
Measured: at 12 hours, 24 hours, and 36 hours after surgery
Surgical site pain
Investigate Intensity of surgical site pain using numerical rating scale (0-10, 0 representing 'no pain', 10 representing 'worst pain imaginable')
Measured: at 12 hours, 24 hours, and 36 hours after surgery
Incidence of postoperative nausea and vomiting (PONV)
The occurrence of PONV is defined as having PONV at least once out of the three measurement time points.
Measured: at 12 hours, 24 hours, and 36 hours after surgery
Time of first walking postoperatively
Time of first walking after transfer to general ward
Measured: After transfer to general ward up to 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study startSep 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionSep 2022 (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 Shoulder PainStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
- Investigators
- Hee-Soo Kim, M.D., PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043844
- Sponsor's protocol ID
- 2107-220-1240
- Status last verified
- Sep 2021
- First submitted
- 27 Aug 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dobbs FF, Kumar V, Alexander JI, Hull MG. Pain after laparoscopy related to posture and ring versus clip sterilization. Br J Obstet Gynaecol. 1987 Mar;94(3):262-6. doi: 10.1111/j.1471-0528.1987.tb02365.x.
PubMed 2952160Ko-Iam W, Paiboonworachat S, Pongchairerks P, Junrungsee S, Sandhu T. Combination of etoricoxib and low-pressure pneumoperitoneum versus standard treatment for the management of pain after laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2016 Nov;30(11):4800-4808. doi: 10.1007/s00464-016-4810-4. Epub 2016 Feb 23.
PubMed 26905574Phelps P, Cakmakkaya OS, Apfel CC, Radke OC. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1155-60. doi: 10.1097/AOG.0b013e31816e34b4.
PubMed 18448749Korell M, Schmaus F, Strowitzki T, Schneeweiss SG, Hepp H. Pain intensity following laparoscopy. Surg Laparosc Endosc. 1996 Oct;6(5):375-9.
PubMed 8890423Sarli L, Costi R, Sansebastiano G, Trivelli M, Roncoroni L. Prospective randomized trial of low-pressure pneumoperitoneum for reduction of shoulder-tip pain following laparoscopy. Br J Surg. 2000 Sep;87(9):1161-5. doi: 10.1046/j.1365-2168.2000.01507.x.
PubMed 10971421Esmat ME, Elsebae MM, Nasr MM, Elsebaie SB. Combined low pressure pneumoperitoneum and intraperitoneal infusion of normal saline for reducing shoulder tip pain following laparoscopic cholecystectomy. World J Surg. 2006 Nov;30(11):1969-73. doi: 10.1007/s00268-005-0752-z.
PubMed 17043939Tsai HW, Chen YJ, Ho CM, Hseu SS, Chao KC, Tsai SK, Wang PH. Maneuvers to decrease laparoscopy-induced shoulder and upper abdominal pain: a randomized controlled study. Arch Surg. 2011 Dec;146(12):1360-6. doi: 10.1001/archsurg.2011.597.
PubMed 22184293Berberoglu 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 9820719Das K, Karateke F, Menekse E, Ozdogan M, Aziret M, Erdem H, Cetinkunar S, Ozdogan H, Sozen S. Minimizing shoulder pain following laparoscopic cholecystectomy: a prospective, randomized, controlled trial. J Laparoendosc Adv Surg Tech A. 2013 Mar;23(3):179-82. doi: 10.1089/lap.2012.0410. Epub 2012 Dec 20.
PubMed 23256585Zeeni 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 31996139Kimura Kuroiwa K, Shiko Y, Kawasaki Y, Aoki Y, Nishizawa M, Ide S, Miura K, Kobayashi N, Sehmbi H. Phrenic Nerve Block at the Azygos Vein Level Versus Sham Block for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial. Anesth Analg. 2021 Jun 1;132(6):1594-1602. doi: 10.1213/ANE.0000000000005305.
PubMed 33332919
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Abdominal Binder Use on Postoperative Shoulder Pain After Laparoscopic Gynecological Surgery
- ClinicalTrials.gov ID
- NCT05043844
- Acronym / sponsor ID
- 2107-220-1240
- Conditions
- Shoulder Pain
- Keywords
- Laparoscopic Surgery, Gynecology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 14 Sep 2021 (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.
The aim of the study is to evaluate the effect of the use of an abdominal binder on postoperative shoulder pain according to laparoscopic gynecological surgery. The investigators will compare the incidences of shoulder pain after laparoscopic gynecological surgery in terms of the use of an abdominal binder.
Detailed description
Laparoscopic surgery has advantages over laparotomy in that it reduces postoperative pain and hospital stay. However, postoperative shoulder pain is one of the major concerns of laparoscopic surgery. Shoulder pain has been reported to occur in 35 to 70% of laparoscopic surgeries. The exact mechanism of shoulder pain after laparoscopic surgery is not clear. The main hypothesis is that the presence of residual carbon dioxide (CO2) in the abdominal cavity stimulates the diaphragmatic nerve and causes pain in the shoulder. Alveolar recruitment maneuver in the Trendelenburg position reduced the intensity and incidence of shoulder pain significantly. However, even with these measures, shoulder pain occurred in 63% of patients after surgery. In addition to this measure, The investigators hypothesized that wearing an abdominal binder would promote the absorption of residual CO2 in the abdominal cavity into the peritoneum and pelvis pressure.
The aim of this study was to evaluate the effect of the use of an abdominal binder on shoulder pain after gynecological laparoscopic surgery.
The intraoperative management is carried out in the same manner, except for wearing an abdominal binder after surgery. Laparoscopic procedure is completed, and then intraperitoneal CO2 is passive drained. An anesthetist places the operating table in the Trendelenburg position at 30 degrees and performs the alveolar recruitment maneuver. (CPAP 45 cm H2O is administered 5 times for 7 seconds) In the abdominal binder group, the patient wears an abdominal binder in the Trendelenburg position and then changed to the supine position before the emergence.
In the control group, the patient placed in the supine position, and emergence is started.
Shoulder pain at 12, 24, and 36 hours after surgery is investigated with a Numeric Score Scale (NRS) score.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –In the control group, an investigator performed only a pulmonary recruitment maneuver on the Trendelenburg position before the emergence of anesthesia. |
| Abdominal binder | Experimental | Device: abdominal binderIn the abdominal binder group, a pulmonary recruitment maneuver was performed on the Trendelenburg position and the abdominal binder which had a standard height of 22 cm was placed on the abdomen of the patient before the emergence of anesthesia. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients aged 20-79 years with ASA I - III undergoing elective laparoscopic gynecological surgery under general anesthesia
Key exclusion criteria (6 listed)
- Patients who do not consent to the trial
- Conversion to open surgery from laparoscopic surgery
- Patients with previous shoulder disease or history of shoulder surgery
- Patients who have difficulty wearing an abdominal binder due to skin disease or wounds in the abdomen
- Development of subcutaneous emphysema
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 |
|---|---|---|
| abdominal binderWearing an abdominal binder postoperatively | Device | Abdominal binder |
Primary outcome
Postoperative shoulder pain
Time frame: Postoperative shoulder pain at 12 hours after surgery
Investigate occurrence of postoperative shoulder pain at 12 hours, 24 hours, and 36 hours after surgery. The occurrence of shoulder pain is defined as having NRS ≥ 1 pain at least once out of the three measurement time points.
Postoperative shoulder pain
Time frame: Postoperative shoulder pain at 24 hours after surgery
Investigate occurrence of postoperative shoulder pain at 12 hours, 24 hours, and 36 hours after surgery. The occurrence of shoulder pain is defined as having NRS ≥ 1 pain at least once out of the three measurement time points.
Postoperative shoulder pain
Time frame: Postoperative shoulder pain at 36 hours after surgery
Investigate occurrence of postoperative shoulder pain at 12 hours, 24 hours, and 36 hours after surgery. The occurrence of shoulder pain is defined as having NRS ≥ 1 pain at least once out of the three measurement time points.
5 secondary outcomes
Intensity of postoperative shoulder pain
Time frame: at 12 hours, 24 hours, and 36 hours after surgery
Shoulder pain depending on posture
Time frame: at 12 hours, 24 hours, and 36 hours after surgery
Surgical site pain
Time frame: at 12 hours, 24 hours, and 36 hours after surgery
Incidence of postoperative nausea and vomiting (PONV)
Time frame: at 12 hours, 24 hours, and 36 hours after surgery
Time of first walking postoperatively
Time frame: After transfer to general ward up to 36 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Background: PubMed 2952160Dobbs FF, Kumar V, Alexander JI, Hull MG. Pain after laparoscopy related to posture and ring versus clip sterilization. Br J Obstet Gynaecol. 1987 Mar;94(3):262-6. doi: 10.1111/j.1471-0528.1987.tb02365.x.
- Background: PubMed 26905574Ko-Iam W, Paiboonworachat S, Pongchairerks P, Junrungsee S, Sandhu T. Combination of etoricoxib and low-pressure pneumoperitoneum versus standard treatment for the management of pain after laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2016 Nov;30(11):4800-4808. doi: 10.1007/s00464-016-4810-4. Epub 2016 Feb 23.
- Background: PubMed 18448749Phelps P, Cakmakkaya OS, Apfel CC, Radke OC. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1155-60. doi: 10.1097/AOG.0b013e31816e34b4.
- 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 10971421Sarli L, Costi R, Sansebastiano G, Trivelli M, Roncoroni L. Prospective randomized trial of low-pressure pneumoperitoneum for reduction of shoulder-tip pain following laparoscopy. Br J Surg. 2000 Sep;87(9):1161-5. doi: 10.1046/j.1365-2168.2000.01507.x.
- Background: PubMed 17043939Esmat ME, Elsebae MM, Nasr MM, Elsebaie SB. Combined low pressure pneumoperitoneum and intraperitoneal infusion of normal saline for reducing shoulder tip pain following laparoscopic cholecystectomy. World J Surg. 2006 Nov;30(11):1969-73. doi: 10.1007/s00268-005-0752-z.
- Background: PubMed 22184293Tsai HW, Chen YJ, Ho CM, Hseu SS, Chao KC, Tsai SK, Wang PH. Maneuvers to decrease laparoscopy-induced shoulder and upper abdominal pain: a randomized controlled study. Arch Surg. 2011 Dec;146(12):1360-6. doi: 10.1001/archsurg.2011.597.
- 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 23256585Das K, Karateke F, Menekse E, Ozdogan M, Aziret M, Erdem H, Cetinkunar S, Ozdogan H, Sozen S. Minimizing shoulder pain following laparoscopic cholecystectomy: a prospective, randomized, controlled trial. J Laparoendosc Adv Surg Tech A. 2013 Mar;23(3):179-82. doi: 10.1089/lap.2012.0410. Epub 2012 Dec 20.
- 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.
- Background: PubMed 33332919Kimura Kuroiwa K, Shiko Y, Kawasaki Y, Aoki Y, Nishizawa M, Ide S, Miura K, Kobayashi N, Sehmbi H. Phrenic Nerve Block at the Azygos Vein Level Versus Sham Block for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial. Anesth Analg. 2021 Jun 1;132(6):1594-1602. doi: 10.1213/ANE.0000000000005305.
- 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.
Hee-Soo Kim, M.D., PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing abdominal binder in people with Shoulder Pain, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 6 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 14 Sep 2021. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoon Jung KIM (821090886452, imovax4@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative shoulder pain (time frame: Postoperative shoulder pain at 12 hours after surgery). The study lists 3 primary outcomes in all. 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 NCT05043844, 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 14 Sep 2021.