NCT Number: NCT07262749
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.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: At 6 hours after surgery
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.
Time frame: At 12 hours after surgery
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.
Time frame: At 24 hours after surgery
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.
Time frame: At 48 hours after surgery
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.
Time frame: Up to 48 hours after surgery
Total amount of opioids and NSAIDs administered during the first 48 hours after surgery will be recorded.
Time frame: Up to 48 hours after surgery
Number of participants experiencing nausea and/or vomiting within 48 hours after surgery.
Time frame: Up to 48 hours after surgery
Time from end of surgery until the first documented return of bowel sounds.
Time frame: Up to 48 hours after surgery
Time from end of surgery until first ambulation.
Contact information is provided by the study sponsor or research team.
Abdulrahmen Mohamed Rageh, MD
CONTACT
Mohamed Shehata Mohamed Osman
CONTACT
Assiut University
Other
Effect of Intraperitoneal Gas Drain on Postoperative Pain After Gynecologic Laparoscopy: A Randomized Controlled Trial.
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