Postoperative Shoulder Pain After Gynecologic LaparoscopyNCT07262749
Intraperitoneal Gas Drainage to Reduce Postoperative Shoulder Pain After Gynecologic Laparoscopy .
A study testing Intraperitoneal Gas Drain in people with Postoperative Shoulder Pain After Gynecologic Laparoscopy, run by Assiut University.
Trial summary
This randomized controlled trial aims to evaluate whether the use of an intraperitoneal gas drain at the end of gynecologic laparoscopic surgery can reduce postoperative shoulder pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Shoulder Pain After Gynecologic Laparoscopy
- What is being tested?
- Intraperitoneal Gas Drain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women undergoing gynecologic laparoscopy lasting more than 20 minutes.
- Able and willing to provide informed consent.
Who cannot join
- Refusal to participate.
- Patients unable to give consent or unable to participate in pain assessment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Intraperitoneal Gas Drain on Postoperative Pain After Gynecologic Laparoscopy: A Randomized Controlled Trial.
This randomized controlled trial aims to evaluate whether the use of an intraperitoneal gas drain at the end of gynecologic laparoscopic surgery can reduce postoperative shoulder pain. Residual carbon dioxide after laparoscopy is believed to irritate the diaphragm and cause referred shoulder pain, which is a common and distressing postoperative symptom. Women undergoing gynecologic laparoscopy lasting more than 20 minutes will be randomized to receive either an intraperitoneal drain for passive gas evacuation or standard care without a drain. Shoulder pain, abdominal pain, analgesic consumption, postoperative nausea and vomiting, and recovery indicators will be assessed during the first 48 hours after surgery.
Read the detailed description
Post-laparoscopic shoulder pain is a frequent complaint after gynecologic laparoscopy and is mainly attributed to residual carbon dioxide retained in the peritoneal cavity, which irritates the diaphragm and stimulates the phrenic nerve. This study is designed to investigate a simple mechanical intervention-placement of an intraperitoneal gas drain-to facilitate passive evacuation of carbon dioxide and potentially reduce postoperative pain.
Women undergoing gynecologic laparoscopy lasting more than 20 minutes at the Department of Obstetrics and Gynecology, Women's Health University Hospital, Assiut University, will be recruited and randomized into two equal groups. The intervention group will receive a plastic intraperitoneal drain placed through the umbilical port and left in situ for 24 hours postoperatively. The control group will undergo standard gas evacuation without drain placement.
Pain will be assessed using a 10-cm Visual Analog Scale (VAS) at recovery, 6, 12, 24, and 48 hours postoperatively for both shoulder and abdominal pain. Secondary outcomes include total analgesic consumption within 48 hours, incidence of postoperative nausea and vomiting, time to return of intestinal sounds, and time to first mobilization. The primary outcome is the mean shoulder pain score at 24 hours.
This trial aims to provide high-quality evidence on the effectiveness of intraperitoneal gas drainage in reducing postoperative discomfort following gynecologic laparoscopy.
- Being tested
- Intraperitoneal Gas Drain
- Keywords
- Laparoscopy, Shoulder Pain, Postoperative Pain, Carbon Dioxide Retention, Intraperitoneal Gas Drain, Gynecologic Surgery, Visual Analog Scale (VAS)
- Medical subject headings
- Shoulder Pain, Pain, Postoperative, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraperitoneal Gas DrainOther
A plastic intraperitoneal drain is placed through the umbilical port at the end of laparoscopic surgery and left in situ for 24 hours to allow passive evacuation of carbon dioxide. This aims to reduce diaphragmatic irritation and postoperative shoulder pain.
| Study group | Role | What they receive |
|---|---|---|
| Intraperitoneal Gas Drain | Experimental | Placement of a plastic intraperitoneal drain through the umbilical port at the end of gynecologic laparoscopy. The drain is left in place for 24 hours to facilitate passive evacuation of residual CO₂ and reduce postoperative shoulder pain. Receives: Other: Intraperitoneal Gas Drain |
| Standard Care (No Drain) | No intervention | Routine postoperative care following gynecologic laparoscopy without placement of an intraperitoneal drain. Standard gas evacuation is performed at the end of the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of postoperative shoulder pain using the Visual Analog Scale (VAS)
Shoulder pain severity will be assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.
Measured: At 24 hours after surgery
Secondary outcomes (8)
Postoperative shoulder pain (VAS) at 6 hours
Pain severity will be measured using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.
Measured: At 6 hours after surgery
Postoperative shoulder pain (VAS) at 12 hours
Pain severity will be measured using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.
Measured: At 12 hours after surgery
Postoperative shoulder pain (VAS) at 24 hours
Pain severity will be measured using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.
Measured: At 24 hours after surgery
Postoperative shoulder pain (VAS) at 48 hours
Pain severity will be measured using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.
Measured: At 48 hours after surgery
Total analgesic consumption within 48 hours
Total amount of opioids and NSAIDs administered during the first 48 hours after surgery will be recorded.
Measured: Up to 48 hours after surgery
Incidence of postoperative nausea and vomiting
Number of participants experiencing nausea and/or vomiting within 48 hours after surgery.
Measured: Up to 48 hours after surgery
Time to return of bowel sounds
Time from end of surgery until the first documented return of bowel sounds.
Measured: Up to 48 hours after surgery
Time to first mobilization
Time from end of surgery until first ambulation.
Measured: Up to 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postoperative Shoulder Pain After Gynecologic LaparoscopyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two parallel groups: one receiving intraperitoneal gas drainage and one receiving standard care without drainage.
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Shehata Mohamed, Assiut University
- Investigators
- Ahmed Fayek Amin Mousa, Principal investigator, Assiut University - Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262749
- Sponsor's protocol ID
- IPD in gynecologic laparoscopy
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee PS, Chen CY, Wang PC, Chao KC, Hsieh CH. Shoulder pain reaches its peak at 12 hours after gynecological laparoscopic surgery and then gradually decreases. Taiwan J Obstet Gynecol. 2025;64(2):187-193. doi:10.1016/j.tjog.2025.01.010
Olguín-Ortega A, Carrillo-Silva J, Hernández-Enríquez M, et al. Post-laparoscopic shoulder pain and strategies for prevention. Front Med. 2024;11:1347961. doi:10.3389/fmed.2024.1347961
Abbott J, Hawe J, Srivastava P, Hunter D, Garry R. Intraperitoneal gas drain to reduce pain after laparoscopy: randomized masked trial. Obstet Gynecol. 2001 Jul;98(1):97-100. doi: 10.1016/s0029-7844(01)01383-7.
PubMed 11430964Swift G, Healey M, Varol N, Maher P, Hill D. A prospective randomised double-blind placebo controlled trial to assess whether gas drains reduce shoulder pain following gynaecological laparoscopy. Aust N Z J Obstet Gynaecol. 2002 Aug;42(3):267-70. doi: 10.1111/j.0004-8666.2002.00267.x.
PubMed 12230061Tsai 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 22184293Jackson 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 8694166Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. doi: 10.1093/bja/79.3.369. No abstract available.
PubMed 9389858
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraperitoneal Gas Drain on Postoperative Pain After Gynecologic Laparoscopy: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07262749
- Acronym / sponsor ID
- IPD in gynecologic laparoscopy
- Keywords
- Laparoscopy, Shoulder Pain, Postoperative Pain, Carbon Dioxide Retention, Intraperitoneal Gas Drain, Gynecologic Surgery, Visual Analog Scale (VAS)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 4 Dec 2025 (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 randomized controlled trial aims to evaluate whether the use of an intraperitoneal gas drain at the end of gynecologic laparoscopic surgery can reduce postoperative shoulder pain. Residual carbon dioxide after laparoscopy is believed to irritate the diaphragm and cause referred shoulder pain, which is a common and distressing postoperative symptom. Women undergoing gynecologic laparoscopy lasting more than 20 minutes will be randomized to receive either an intraperitoneal drain for passive gas evacuation or standard care without a drain. Shoulder pain, abdominal pain, analgesic consumption, postoperative nausea and vomiting, and recovery indicators will be assessed during the first 48 hours after surgery.
Detailed description
Post-laparoscopic shoulder pain is a frequent complaint after gynecologic laparoscopy and is mainly attributed to residual carbon dioxide retained in the peritoneal cavity, which irritates the diaphragm and stimulates the phrenic nerve. This study is designed to investigate a simple mechanical intervention-placement of an intraperitoneal gas drain-to facilitate passive evacuation of carbon dioxide and potentially reduce postoperative pain.
Women undergoing gynecologic laparoscopy lasting more than 20 minutes at the Department of Obstetrics and Gynecology, Women's Health University Hospital, Assiut University, will be recruited and randomized into two equal groups. The intervention group will receive a plastic intraperitoneal drain placed through the umbilical port and left in situ for 24 hours postoperatively. The control group will undergo standard gas evacuation without drain placement.
Pain will be assessed using a 10-cm Visual Analog Scale (VAS) at recovery, 6, 12, 24, and 48 hours postoperatively for both shoulder and abdominal pain. Secondary outcomes include total analgesic consumption within 48 hours, incidence of postoperative nausea and vomiting, time to return of intestinal sounds, and time to first mobilization. The primary outcome is the mean shoulder pain score at 24 hours.
This trial aims to provide high-quality evidence on the effectiveness of intraperitoneal gas drainage in reducing postoperative discomfort following gynecologic laparoscopy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into two parallel groups: one receiving intraperitoneal gas drainage and one receiving standard care without drainage.
| Arm | Type | Receives |
|---|---|---|
| Intraperitoneal Gas Drain | Experimental | Other: Intraperitoneal Gas DrainPlacement of a plastic intraperitoneal drain through the umbilical port at the end of gynecologic laparoscopy. The drain is left in place for 24 hours to facilitate passive evacuation of residual CO₂ and reduce postoperative shoulder pain. |
| Standard Care (No Drain) | No intervention | –Routine postoperative care following gynecologic laparoscopy without placement of an intraperitoneal drain. Standard gas evacuation is performed at the end of the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women undergoing gynecologic laparoscopy lasting more than 20 minutes.
- Able and willing to provide informed consent.
Key exclusion criteria (2 listed)
- Refusal to participate.
- Patients unable to give consent or unable to participate in pain assessment.
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 |
|---|---|---|
| Intraperitoneal Gas DrainA plastic intraperitoneal drain is placed through the umbilical port at the end of laparoscopic surgery and left in situ for 24 hours to allow passive evacuation of carbon dioxide. This aims to reduce diaphragmatic irritation and postoperative shoulder pain. | Other | Intraperitoneal Gas Drain |
Primary outcome
Severity of postoperative shoulder pain using the Visual Analog Scale (VAS)
Time frame: At 24 hours after surgery
Shoulder pain severity will be assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.
8 secondary outcomes
Postoperative shoulder pain (VAS) at 6 hours
Time frame: At 6 hours after surgery
Postoperative shoulder pain (VAS) at 12 hours
Time frame: At 12 hours after surgery
Postoperative shoulder pain (VAS) at 24 hours
Time frame: At 24 hours after surgery
Postoperative shoulder pain (VAS) at 48 hours
Time frame: At 48 hours after surgery
Total analgesic consumption within 48 hours
Time frame: Up to 48 hours after surgery
Incidence of postoperative nausea and vomiting
Time frame: Up to 48 hours after surgery
Time to return of bowel sounds
Time frame: Up to 48 hours after surgery
Time to first mobilization
Time frame: Up to 48 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- BackgroundLee PS, Chen CY, Wang PC, Chao KC, Hsieh CH. Shoulder pain reaches its peak at 12 hours after gynecological laparoscopic surgery and then gradually decreases. Taiwan J Obstet Gynecol. 2025;64(2):187-193. doi:10.1016/j.tjog.2025.01.010
- BackgroundOlguín-Ortega A, Carrillo-Silva J, Hernández-Enríquez M, et al. Post-laparoscopic shoulder pain and strategies for prevention. Front Med. 2024;11:1347961. doi:10.3389/fmed.2024.1347961
- Background: PubMed 11430964Abbott J, Hawe J, Srivastava P, Hunter D, Garry R. Intraperitoneal gas drain to reduce pain after laparoscopy: randomized masked trial. Obstet Gynecol. 2001 Jul;98(1):97-100. doi: 10.1016/s0029-7844(01)01383-7.
- Background: PubMed 12230061Swift G, Healey M, Varol N, Maher P, Hill D. A prospective randomised double-blind placebo controlled trial to assess whether gas drains reduce shoulder pain following gynaecological laparoscopy. Aust N Z J Obstet Gynaecol. 2002 Aug;42(3):267-70. doi: 10.1111/j.0004-8666.2002.00267.x.
- 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 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 9389858Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. doi: 10.1093/bja/79.3.369. No abstract available.
- 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.
Ahmed Fayek Amin Mousa principal investigator
Assiut University - Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Intraperitoneal Gas Drain in people with Postoperative Shoulder Pain After Gynecologic Laparoscopy, run by Assiut University.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Shehata Mohamed Osman (01015530934, Moha.shehata2016@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of postoperative shoulder pain using the Visual Analog Scale (VAS) (time frame: At 24 hours after 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 NCT07262749, which also lists 7 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 4 Dec 2025.