Pain Relief Following Laparoscopic Cholecystectomy While Comparing Intra Abdominal Versus Sub Cutaneous Local Anesthetic Administration

Официальное название

Comparative Evaluation of Analgesic Outcomes of Intra-peritoneal Versus Subcutaneous Infiltration of Bupivacaine for Laparoscopic Cholecystectomy Patients "

Обзор

Laparoscopic cholecystectomy involves removal of gallbladder through small incision ports resulting in faster recovery. Small incisions are less painful and hence local anesthesis administered can be effective for pain management. This local anesthetic can be administered either within abdominal cavity or at sit of small incisions.

Подробное описание

Laparoscopic cholecystectomy is a minimally invasive surgical procedure involving removal of the gallbladder through multiple small trocar incisions. Compared with open surgery, this approach is associated with reduced postoperative pain, shorter hospital stay, and faster recovery. Despite its minimally invasive nature, postoperative pain remains a significant concern, particularly at port sites and from intraperitoneal irritation. Local anesthetic techniques have been shown to contribute to multimodal analgesia in laparoscopic surgery. Local anesthetic agents may be administered either intraperitoneally or by infiltration at trocar insertion sites to reduce postoperative pain and opioid requirements. However, the optimal route of local anesthetic administration for effective postoperative analgesia following laparoscopic cholecystectomy remains uncertain, warranting further clinical evaluation.

Вмешательства

• Препарат Intraoperitoneal local anesthetic administration
  Intraperitoneal infiltration of 20ml of 0.25% Bupivacaine will be done at the end of procedure by the surgeon.
• Препарат Sub cutaneous administration of local anesthetic
  port site infiltration of 20ml of 0.25% Bupivacaine will be done. 6ml for 10mm ports and 4ml for 5mm ports respectively.

Первичные конечные точки

• Post opestive pain score [Срок оценки: This will be measured using Visual Analog score upon arrival at post anesthesia care unit labelled as Time 0 then at time intervals 3h,6h, 12h and 24 hours post operatively]
• Rescue analgesia demand [Срок оценки: This will be the number of patients requiring resuce analgesia in 24h post operative period. Rescue analgesia will be administered if VAS score >4]

Критерии участия

Критерии включения

• ASA I and II

Критерии исключения

• Allergic to local anesthetic Open cholecystectomy History of chronic pain History of abdominal surgery

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Rawalpindi Teaching Hospital, Rawalpindi — Rawalpindi

Публикации

• Bano N, Hayat N, Saleem S, Javaid F, Rehman A, Mudassir. Comparison of intraincisional and intraperitoneal infiltration of local anaesthetic in laparoscopic cholecystectomy to control early postoperative pain. Professional Med J 2021; 28(2):192-196. https://doi.org/10.29309/TPMJ/2021.28.02.6013

Идентификаторы

NCT: NCT07409688 · 4726/RTH/RWP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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