External Oblique Intercostal Plane Block for Postoperative Analgesia After Major Upper Abdominal Surgery

Официальное название

External Oblique Intercostal Plane Block for Postoperative Analgesia After Major Upper Abdominal Surgery: A Randomized Controlled Trial

Обзор

Postoperative pain after laparoscopic major upper abdominal surgery (e.g., gastric, hepatic, gallbladder, pancreatic surgery) is often severe, and inadequate analgesia may lead to increased opioid use, opioid dependence, and poor functional recovery. Current analgesic techniques such as neuraxial block have safety concerns (e.g., hypotension, neurological injury), while transversus abdominis plane (TAP) block is ineffective for blocking the lateral cutaneous branches of intercostal nerves in the upper abdomen. The External Oblique Intercostal Plane Block (EOIB) is a novel regional block technique that has shown promise in reducing postoperative opioids and pain in small-scale studies, but evidence for its use in major upper abdominal surgery is limited. This randomized controlled trial (RCT) aims to evaluate the analgesic efficacy and safety of bilateral EOIB combined with standard multimodal analgesia versus standard multimodal analgesia alone in patients undergoing elective laparoscopic major upper abdominal surgery. The primary outcome is the total postoperative opioid consumption (measured as Morphine Milligram Equivalents, MME) within 24 hours. Secondary and additional outcomes include pain scores (Verbal Rating Scale, VRS), recovery quality (QoR-15 scale), incidence of adverse events, and hospital stay.

Подробное описание

Postoperative pain after major upper abdominal surgery is common and may delay recovery and increase opioid-related adverse effects. The External Oblique Intercostal Plane Block (EOIB) is a novel fascial plane block intended to improve analgesia for upper abdominal incisions.

This study is a prospective, single-center, randomized, assessor-blinded controlled trial in adults (18-85 years, ASA I-III) scheduled for elective major upper abdominal laparoscopic-assisted surgery (e.g., gastric, hepatic, gallbladder, pancreatic procedures) with expected operative time ≥2 hours and planned use of IV patient-controlled analgesia (PCA). Participants will be randomized 1:1 using a computer-generated, variable block-size sequence with allocation concealment via opaque sealed envelopes. The block-performing anesthesiologist will not collect outcomes; outcome assessors will be blinded to group assignment.

After induction of general anesthesia and before surgical incision, patients in the intervention group will receive ultrasound-guided bilateral EOIB at the 6th rib level using an in-plane technique; 25 mL 0.3% ropivacaine per side. Control participants will receive no regional block. All participants will receive standardized multimodal analgesia including IV PCA, antiemetic prophylaxis (dexamethasone 5 mg; ondansetron as needed), and NSAID use per ERAS practice.

The primary endpoint is total opioid consumption during the first 24 hours after surgery, expressed as IV morphine milligram equivalents (MME), including PCA and rescue opioids. Secondary outcomes include postoperative pain scores (0-10 verbal rating scale) at prespecified time points (including 24, 48, and 72 hours; at rest and with activity as applicable), quality of recovery (QoR-15 at 24/48/72 hours), opioid consumption at 24-48 hours, postoperative nausea and vomiting within 72 hours, intraoperative hemodynamic events, time to first flatus, and postoperative length of stay.

Вмешательства

• Процедура External Oblique Intercostal Plane Block
  Ultrasound-guided bilateral external oblique intercostal plane block (EOIB) performed after induction of general anesthesia and before surgical incision. Using an in-plane technique at the 6th rib level, 25 mL 0.3% ropivacaine per side is injected between the external oblique muscle and the intercostal muscle. Standard multimodal analgesia is also provided to all participants.
• Другое Standard multimodal analgesia
  Standard multimodal analgesia per institutional ERAS practice, including intravenous patient-controlled analgesia (IV PCA) with opioids and adjunct non-opioid analgesics (e.g., NSAIDs and/or acetaminophen) with antiemetic prophylaxis as needed. No regional block is administered.

Первичные конечные точки

• Total opioid consumption within 24 hours after surgery (IV morphine milligram equivalents, MME) [Срок оценки: 0-24 hours postoperatively (from end of surgery to 24 hours after surgery)]

Вторичные конечные точки (2)

• Postoperative Pain Score Within 24 Hours Postoperatively [Срок оценки: Within 24 hours postoperatively]
• Postoperative Recovery Quality at 24 Hours Postoperatively [Срок оценки: 24 hours postoperatively]

Критерии участия

Критерии включения

• Obtain written informed consent from participants or their legal representatives
• Age between 18 and 85 years
• American Society of Anesthesiologists (ASA) physical status classification I-III
• Scheduled for elective laparoscopic major upper abdominal surgery (e.g., gastric, hepatic, gallbladder, pancreatic surgery)
• Expected surgical duration ≥ 2 hours
• Ability to use the intravenous patient-controlled analgesia (IV PCA) system

Критерии исключения

• Hepatic disease (liver enzyme levels ≥ 2× the upper limit of normal)
• Renal disease (serum creatinine levels ≥ 2× the upper limit of normal)
• Allergy to local anesthetics or known study-related drugs
• Pregnancy or lactation
• Low surgical incision site (not involving the upper abdominal wall innervated by T6-T10 nerves)
• Coagulopathy or current use of anticoagulant medications
• Opioid use for more than 2 weeks in the past 6 months

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

Китай · 1 центр

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07331441 · 2512335-12

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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