Analgesic Efficacy of Bupivacaine Infiltration, Erector Spinae Plane Block, and Intrathecal Morphine in Laparoscopic Cholecystectomy

Официальное название

A Prospective, Randomized Controlled Study Comparing the Analgesic Efficacy of Bupivacaine Infiltration of the Gallbladder Bed and Trocar Sites, Erector Spinae Plane Block, and Intrathecal Morphine in Patients Undergoing Laparoscopic Cholecystectomy

Обзор

This study is designed to compare three different methods of pain control after laparoscopic gallbladder surgery (laparoscopic cholecystectomy). Although this surgery is minimally invasive, participants often experience different types of pain after the operation, such as pain at the incision site, pain inside the abdomen, and shoulder pain caused by the gas used during surgery. The investigators will compare three commonly used pain relief techniques: Local infiltration - injecting a numbing medicine (bupivacaine) into the gallbladder bed and at the sites where the surgical instruments are placed. Erector spinae plane (ESP) block - an ultrasound-guided nerve block performed in the back to reduce both abdominal and incisional pain. Intrathecal morphine - a very small dose of morphine given into the spinal fluid before surgery to provide long-lasting pain relief. The goal is to determine which method provides the best pain control, reduces the need for opioid medications, and improves recovery after surgery.

Подробное описание

Laparoscopic cholecystectomy is the standard surgical treatment for gallbladder diseases. Despite being a minimally invasive procedure, postoperative pain is a frequent problem and can negatively affect early mobilization, oral intake, and overall recovery. The pain experienced after this surgery is multifactorial, including somatic pain at trocar sites, visceral pain at the gallbladder bed, and shoulder pain caused by carbon dioxide insufflation. Effective pain management is therefore essential to improve patient comfort, reduce opioid consumption, and shorten hospital stay.

Several methods are available for postoperative analgesia. Local infiltration of the gallbladder bed and trocar sites with bupivacaine provides targeted pain relief at areas of surgical trauma. Erector spinae plane (ESP) block, a recently described ultrasound-guided regional anesthesia technique, offers both somatic and visceral analgesia with a favorable safety profile. Low-dose intrathecal morphine has also been shown to provide strong and prolonged analgesia in abdominal surgery, though its use may be limited by side effects such as nausea, vomiting, and itching.

This single-center, prospective, randomized controlled trial will compare the analgesic efficacy of three techniques:

Group INF (Infiltration): Bupivacaine infiltration at the gallbladder bed and trocar sites.

Group ESP: Bilateral ultrasound-guided ESP block at the T7 level.

Group ITM: Intrathecal morphine administration before induction of anesthesia.

The primary outcome is total opioid consumption within the first 24 hours after surgery.

Secondary outcomes include postoperative pain scores at multiple time points using the Visual Analog Scale (VAS), as well as the incidence of side effects such as nausea, vomiting, pruritus, and respiratory depression.

The results of this study are expected to provide evidence to guide multimodal analgesia strategies in laparoscopic cholecystectomy and to optimize patient recovery and satisfaction.

Вмешательства

• Препарат Bupivacaine Infiltration
  After removal of the gallbladder, 40 mL of 0.25% bupivacaine will be applied to the gallbladder bed with a sterile sponge for 10-15 minutes. At the end of the surgery, 15 mL of 0.25% bupivacaine will be infiltrated into trocar insertion sites (5 mL umbilical port, 5 mL epigastric port, 5 mL each auxiliary port).
• Процедура Erector Spinae Plane Block
  Before induction of anesthesia, a bilateral ultrasound-guided erector spinae plane block will be performed at the T7 transverse process level. A total of 40 mL of 0.25% bupivacaine will be injected (20 mL per side) using an in-plane technique under ultrasound guidance.
• Препарат Intrathecal Morphine
  With the patient in the sitting position, a 27-gauge spinal needle will be inserted at the L3-L4 interspace. A dose of 100 mcg morphine will be administered intrathecally before induction of anesthesia.

Первичные конечные точки

• Total Opioid Consumption in the First 24 Hours [Срок оценки: 0-24 hours postoperatively]

Вторичные конечные точки (4)

• Postoperative Pain Scores (Visual Analog Scale, VAS) [Срок оценки: At 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hours postoperatively]
• Incidence of Postoperative Nausea and Vomiting (PONV) [Срок оценки: 0-24 hours postoperatively]
• Incidence of Pruritus [Срок оценки: 0-24 hours postoperatively]
• Incidence of Respiratory Depression [Срок оценки: 0-24 hours postoperatively]

Критерии участия

Критерии включения

• Adults aged 18-65 years
• Scheduled for elective laparoscopic cholecystectomy
• American Society of Anesthesiologists (ASA) physical status I-III
• Able to provide written informed consent

Критерии исключения

• Body mass index (BMI) > 35 kg/m²
• History of coagulopathy or bleeding disorders
• Known allergy or hypersensitivity to opioids or local anesthetics
• Chronic pain or regular analgesic use
• History of neurological or psychiatric disease
• Pregnancy
• Refusal to participate in the study

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Ataturk University — Erzurum

Публикации

• Motamed C, Bouaziz H, Franco D, Benhamou D. Analgesic effect of low-dose intrathecal morphine and bupivacaine in laparoscopic cholecystectomy. Anaesthesia. 2000 Feb;55(2):118-24. doi: 10.1046/j.1365-2044.2000.055002118.x. PMID 10651671
• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. PMID 27501016
• Altuntas G, Akkaya OT, Ozkan D, Sayin MM, Balas S, Ozlu E. Comparison of Intraabdominal and Trocar Site Local Anaesthetic Infiltration on Postoperative Analgesia After Laparoscopic Cholecystectomy. Turk J Anaesthesiol Reanim. 2016 Dec;44(6):306-311. doi: 10.5152/TJAR.2016.75983. Epub 2016 Dec 1. PMID 28058142
• Ahmed SM, Shabbir S, Rana NA, Khatoon A, Ghani UF, Basharat I, Khan MN, Hameed FM, Dar MF. Ideal Local Anesthetic for Intraperitoneal Gallbladder Bed Infiltration Following Laparoscopic Cholecystectomy: A Randomized Controlled Trial. Cureus. 2024 Oct 9;16(10):e71122. doi: 10.7759/cureus.71122. eCollection 2024 Oct. PMID 39525126
• Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. doi: 10.1016/S0140-6736(03)14966-5. PMID 14667752

Идентификаторы

NCT: NCT07203794 · B.30.2.ATA.0.01.00/616 · 2025/2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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