Low Versus Standard Volume EXORA Block in Laparoscopic Cholecystectomy

Official title

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

Overview

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.

Detailed description

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

Interventions

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

Primary outcome measures

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

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

Egypt · 1 center

• Fayoum University hospital — El Fayoum Qesm

Publications

• 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

Identifiers

NCT: NCT07507799 · M 871

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗