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

Assiut University

Status: Not yet enrolling

Conditions: Postoperative Shoulder Pain After Gynecologic Laparoscopy

Treatments: Other: Intraperitoneal Gas Drain

Study type: Interventional

Funder types: Other

Identifiers

NCT07262749

IPD in gynecologic laparoscopy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Intraperitoneal Gas Drain

Experimental group

Description:

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.

Treatment:

Other: Intraperitoneal Gas Drain

Standard Care (No Drain)

No Intervention group

Description:

Routine postoperative care following gynecologic laparoscopy without placement of an intraperitoneal drain. Standard gas evacuation is performed at the end of the procedure.