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

Официальное название

Effect of Intraperitoneal Gas Drain on Postoperative Pain After Gynecologic Laparoscopy: A Randomized Controlled Trial.

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Severity of postoperative shoulder pain using the Visual Analog Scale (VAS) [Срок оценки: At 24 hours after surgery]

Вторичные конечные точки (8)

• Postoperative shoulder pain (VAS) at 6 hours [Срок оценки: At 6 hours after surgery]
• Postoperative shoulder pain (VAS) at 12 hours [Срок оценки: At 12 hours after surgery]
• Postoperative shoulder pain (VAS) at 24 hours [Срок оценки: At 24 hours after surgery]
• Postoperative shoulder pain (VAS) at 48 hours [Срок оценки: At 48 hours after surgery]
• Total analgesic consumption within 48 hours [Срок оценки: Up to 48 hours after surgery]
• Incidence of postoperative nausea and vomiting [Срок оценки: Up to 48 hours after surgery]
• Time to return of bowel sounds [Срок оценки: Up to 48 hours after surgery]
• Time to first mobilization [Срок оценки: Up to 48 hours after surgery]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 11430964
• 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. PMID 12230061
• 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. PMID 22184293
• 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. PMID 8694166
• Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. doi: 10.1093/bja/79.3.369. No abstract available. PMID 9389858

Идентификаторы

NCT: NCT07262749 · IPD in gynecologic laparoscopy

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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