Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 COâ‚‚ 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraperitoneal Gas Drain | Other | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Shehata Mohamed Osman | Contact | 01015530934 | Moha.shehata2016@gmail.com | |
| Abdulrahmen Mohamed Rageh, MD | Contact | +20 100 505 6259 | Abdulrahmanrageh@med.aun.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed Fayek Amin Mousa | Assiut University - Faculty of Medicine | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| Background | OlguÃn-Ortega A, Carrillo-Silva J, Hernández-EnrÃquez M, et al. Post-laparoscopic shoulder pain and strategies for prevention. Front Med. 2024;11:1347961. doi:10.3389/fmed.2024.1347961 | ||
| 11430964 | Background | 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. | |
| 12230061 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D010149 | Pain, Postoperative |
| D006935 | Hypercapnia |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
Not provided
Not provided
Participants will be randomized into two parallel groups: one receiving intraperitoneal gas drainage and one receiving standard care without drainage.
Not provided
Not provided
Not provided
Not provided
|
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 |
| Background |
| 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. |
| 22184293 | Background | 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. |
| 8694166 | Background | 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. |
| 9389858 | Background | Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. doi: 10.1093/bja/79.3.369. No abstract available. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D012818 | Signs and Symptoms, Respiratory |