Intraperitoneal Gas Drainage to Reduce Postoperative Shoulder Pain After Gynecologic Laparoscopy .

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Shoulder Pain After Gynecologic Laparoscopy
• Intervention / Treatment: Other: Intraperitoneal Gas Drain

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 Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Shehata Mohamed Osman; Phone Number: 01015530934; Email: Moha.shehata2016@gmail.com
• Study Contact Backup: Name: Abdulrahmen Mohamed Rageh, MD; Phone Number: +20 100 505 6259; Email: Abdulrahmanrageh@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women undergoing gynecologic laparoscopy lasting more than 20 minutes.
• Able and willing to provide informed consent.

Exclusion Criteria:

• Refusal to participate.
• Patients unable to give consent or unable to participate in pain assessment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intraperitoneal Gas Drain; 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.	Other: Intraperitoneal Gas Drain; 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.
No Intervention: Standard Care (No Drain); 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	Up to 48 hours after surgery
Time to first mobilization	Time from end of surgery until first ambulation.	Up to 48 hours after surgery

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Ahmed Fayek Amin Mousa, Assiut University - Faculty of Medicine

Publications and helpful links

General Publications

• Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. doi: 10.1093/bja/79.3.369. No abstract available.
• Jackson 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.
• Tsai 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.
• 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.
• Swift 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.
• 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

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative Pain; Shoulder Pain; Laparoscopy; Visual Analog Scale (VAS); Gynecologic Surgery; Carbon Dioxide Retention; Intraperitoneal Gas Drain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Joint Diseases; Signs and Symptoms, Respiratory; Arthralgia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Shoulder Pain; Hypercapnia
• Other Study ID Numbers: IPD in gynecologic laparoscopy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No