Low Versus Standard Volume EXORA Block in Laparoscopic Cholecystectomy

Официальное название

Analgesic Efficacy of Low-Volume Versus Standard-Volume 0.25% Bupivacaine for Ultrasound-Guided External Oblique and Rectus Abdominis Plane Block in Laparoscopic Cholecystectomy, A Randomized Non-Inferiority Trial

Обзор

The original EXORA block used high local anesthetic volume (50 mL total), raising concerns about local anesthetic systemic toxicity (LAST). In such a bilaterally administered regional technique, evaluating the efficacy of a reduced-volume approach is warranted to maximize patient safety.

Подробное описание

Study Design \& Population This is a prospective, randomized, double-blinded trial enrolling patients scheduled for elective laparoscopic cholecystectomy. Following informed consent, patients will be randomly allocated into two equal groups to evaluate different volumes used in a bilateral, ultrasound-guided External Oblique and Rectus Abdominis (EXORA) block.

Interventions Prior to the induction of general anesthesia, patients will receive a bilateral EXORA block using 0.25% bupivacaine.

Group E15: Will receive 15 mL of the local anesthetic on each side. Group E25: Will receive 25 mL of the local anesthetic on each side. Blinding \& Allocation Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. The block will be performed by a designated regional anesthesiologist who will not be involved in subsequent patient care. The patient, the surgical team, the intraoperative anesthesiologist, and the postoperative data collectors will remain strictly blinded to the group allocation and the volume injected.

Anesthesia \& Perioperative Management Sensory block distribution will be assessed prior to surgery. All patients will receive a standardized general anesthesia protocol for induction and maintenance. Intraoperative hemodynamics will be managed according to standard institutional protocols.

Postoperative Analgesia \& Monitoring Upon transfer to the Post-Anesthesia Care Unit (PACU) and throughout the first 24 hours, all patients will receive scheduled, standardized multimodal analgesia (intravenous paracetamol and ketorolac). Postoperative pain will be assessed using the 11-point Numerical Rating Scale (NRS) at rest and during movement at prespecified time points. If the dynamic NRS score is ≥ 4, intravenous morphine (2 mg) will be administered . Patients will be continuously monitored for adverse events, including postoperative nausea and vomiting (PONV), hemodynamic instability, and local anesthetic systemic toxicity (LAST), which will be managed with predefined rescue medications

Вмешательства

• Процедура EXORA block 15
  15 mL of bupivacaine 0.25% administered bilaterally by ultrasound guided EXORA block
• Процедура EXORA block 25
  25 mL of bupivacaine 0.25% administered bilaterally by ultrasound guided EXORA block

Первичные конечные точки

• Dynamic numerical rating scale (NRS) score at 4 hours postoperatively. [Срок оценки: 4 hours after surgery]

Вторичные конечные точки (12)

• Static Numerical Rating scale NRS scores [Срок оценки: up to 24 hours post operatively]
• Dynamic numerical rating scale NRS scores [Срок оценки: up to 24 hours post operatively]
• Cumulative Static Pain Burden [Срок оценки: Up to 24h postoperatively]
• Cumulative Dynamic Pain Burden [Срок оценки: Up to 24h postoperatively]
• Intraoperative Fentanyl consumption Total fentanyl in micrograms [Срок оценки: From induction of anesthesia until patient is transferred to postoperative care unit up to 4 hours]]
• Total cumulative consumption of intravenous morphine over the first 24 hours. [Срок оценки: At 24 hours postoperatively]
• Time to first rescue analgesia [Срок оценки: Upon recovery from General anesthesia up to 24 hours postoperatively]]
• Sensory block distribution level (pin-prick test) [Срок оценки: At 30 minuets from the block]
• Quality of recovery score (QoR-15) at 24 hours. [Срок оценки: At 24 hours postoperatively]
• Incidence of adverse events: bradycardia, hypotension, PONV, and LAST. [Срок оценки: From induction of anesthesia up to 24 hours postoperatively]
• Heart rate [Срок оценки: Upon arrival to Operating Room until 24 hours postoperative]
• Mean arterial pressure [Срок оценки: Upon arrival to Operating Room until 24 hours postoperative]

Критерии участия

Критерии включения

• American Society of Anesthesiologists (ASA) physical status I or II.
• Scheduled for elective laparoscopic cholecystectomy under general anesthesia.

Критерии исключения

• • Patient refusal to participate.

• Obese patients with a body mass index of more than 35 kg/m2.
• Known cognitive impairment or use of psychiatric drugs
• Known allergy to local anesthetics
• Infection at the needle insertion site.
• Coagulopathy, or bleeding disorders.
• Pregnancy
• History of chronic pain or chronic opioid use.
• Previous major upper abdominal surgery (which alters the fascial planes and anatomy).

Criteria for Withdrawal from Study Analysis (Drop-outs):

• Conversion to open cholecystectomy during surgery.
• Failed EXORA block

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

Четверное слепое

Основная цель

Профилактика

Центры проведения

Египет · 1 центр

• Fayoum University hospital — El Fayoum Qesm

Публикации

• Okmen K, Demirel A, Dogan AK, Ertus CY. Application of EXORA block for analgesia following hand-assisted laparoscopic donor nephrectomy (HALDN). Indian J Anaesth. 2025 Mar;69(3):324-326. doi: 10.4103/ija.ija_1263_24. Epub 2025 Feb 17. No abstract available. PMID 40161911
• Okmen K, Yildiz DK, Ulker GK. Evaluation of the efficacy of M-TAPA and EXORA block application for analgesia after laparoscopic cholecystectomy: a prospective, single-blind, observational study. Korean J Anesthesiol. 2025 Aug;78(4):361-368. doi: 10.4097/kja.24563. Epub 2025 Apr 15. PMID 40230270
• Fernandez Martin MT, Lopez Alvarez S, Valdes-Vilches LF. EXORA block: a new approach for laparoscopic cholecystectomy analgesia? Minerva Anestesiol. 2024 May;90(5):462-463. doi: 10.23736/S0375-9393.23.17863-1. Epub 2024 Jan 29. No abstract available. PMID 38287777
• Kumar K, Kirksey MA, Duong S, Wu CL. A Review of Opioid-Sparing Modalities in Perioperative Pain Management: Methods to Decrease Opioid Use Postoperatively. Anesth Analg. 2017 Nov;125(5):1749-1760. doi: 10.1213/ANE.0000000000002497. PMID 29049119
• De Cassai A, Sella N, Geraldini F, Tulgar S, Ahiskalioglu A, Dost B, Manfrin S, Karapinar YE, Paganini G, Beldagli M, Luoni V, Ordulu BBK, Boscolo A, Navalesi P. Single-shot regional anesthesia for laparoscopic cholecystectomies: a systematic review and network meta-analysis. Korean J Anesthesiol. 2023 Feb;76(1):34-46. doi: 10.4097/kja.22366. Epub 2022 Nov 8. PMID 36345156
• Ekstein P, Szold A, Sagie B, Werbin N, Klausner JM, Weinbroum AA. Laparoscopic surgery may be associated with severe pain and high analgesia requirements in the immediate postoperative period. Ann Surg. 2006 Jan;243(1):41-6. doi: 10.1097/01.sla.0000193806.81428.6f. PMID 16371735

Идентификаторы

NCT: NCT07507799 · M 871

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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