EXORA vs ESP Blocks in Laparoscopic Cholecystectomy

NCT07187310 | Recruiting

• 1 other identifier: M829
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic cholecystectomy is still considered the gold standard for the surgical management of gallbladder disease due to its minimally invasive nature, shorter recovery time, and reduced postoperative complications. Despite these advantages, patients frequently experience moderate to severe postoperative pain, particularly in the early postoperative period, which can impede recovery, delay mobilization, and increase opioid consumption. Excessive opioid use after laparoscopic cholecystectomy is associated with several drawbacks, including nausea, vomiting, sedation, and delayed recovery. It also increases the risk of respiratory depression, especially in vulnerable patients, and may contribute to long-term opioid dependence. These risks highlight the importance of opioid-sparing strategies such as regional anesthesia techniques to improve patient outcomes and enhance recovery. Regional anesthesia techniques have emerged as essential components of multimodal analgesia strategies in abdominal surgeries. Among them, the Erector Spinae Plane (ESP) Block has gained popularity due to its relative ease of administration and favorable safety profile. Recently, a novel fascial plane block known as the EXORA block has been introduced as a promising alternative for abdominal wall analgesia. This block, which targets a different anatomical plane, is postulated to provide comparable or superior analgesic efficacy to traditional methods while maintaining safety and simplicity in execution. Given the ongoing pursuit of optimal analgesia with minimal side effects, it is essential to compare emerging techniques, such as the EXORA block, with established methods like the ESP block. The authors hypothesize that the EXORA and the ESP blocks provide superior postoperative analgesia compared to controls in the anterolateral abdomen in patients undergoing laparoscopic cholecystectomy and that the EXORA block analgesic profile is comparable to that of the ESP block.

Conditions

Postoperative Pain

Keywords

EXORA block; Erector spinae Plain block; Regional Anesthesia for Laparoscopic Cholecystectomy; Postoperative pain management in abdominal surgeries

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption

  Post operative nalbuphine used in the first 24 hours in milligrams

  Up to 24 hours after surgery

Secondary Outcomes (9)

• Intraoperative Fentanyl consumption

  From induction of anesthesia until patient is transferred to postoperative care unit up to 4 hours

• Time needed to complete the block

  From start of block procedure up to 1 hour

• Sensory block distribution level (pin-prick test)

  after 30 minuets from the block maneuver bilaterally

• Heart rate

  Upon arrival to Operating Room until 24 hours postoperative

• Blood pressure

  Upon arrival to Operating Room until 24 hours postoperative

Other Outcomes (1)

• Quality of recovery (QoR-15)

  At 24 hours postoperatively

Study Arms (3)

EXORA block group

EXPERIMENTAL

Group A (EXORA Block Group): Patients will receive bilateral EXORA blocks.

Procedure: EXORA block

ESP block group

ACTIVE COMPARATOR

Group B (ESP Block Group): Patients will receive bilateral ESP blocks.

Procedure: Erector Spinae Plane block

control group

NO INTERVENTION

Group C (Control Group): patients will not receive any block, only standard care.

Interventions

EXORA block PROCEDURE

in a supine position, a linear Ultrasound probe (L6-12 RS linear array transducer (6-12 MHz) on GE Healthcare Logiq P7, made in Korea) will be sagittally applied at the parasternal line, lateral to the sternum and xiphoid process. The probe will be manipulated craniocaudally to identify the 6th, 7th, and 8th costal cartilages. At the level of the 8th costal cartilage, a transverse orientation will be used to visualize the rectus abdominis muscle and the costal cartilage beneath. An 88-mm, 22-gauge needle will be directed in-plane from medial to lateral. After confirming the needle position below the rectus abdominis muscle using 4 ml isotonic saline as a hydro-dissection, 25 ml of plain bupivacaine 0.25% concentration will be injected. the spread of the local anesthetic is to be observed to advance laterally under the external oblique muscle and medially under the rectus muscle. The same procedure will be repeated on the other side.

EXORA block group

Erector Spinae Plane block PROCEDURE

in a right lateral position, the linear Ultrasound probe will be placed vertically 3 cm lateral to the midline at the level of the 7th thoracic spinal process, identifying the T7 transverse process, and the overlying erector spinae (ES) muscle. An 88-mm, 22-gauge needle will be advanced craniocaudally in-plane until hitting the T7 transverse process. After using hydro-dissection with 4 ml of isotonic saline to confirm the correct needle position, 25 ml of 0.25% bupivacaine will be administered below the erector spinae muscle. The same procedure will be repeated on the other side.

ESP block group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective laparoscopic cholecystectomy
• ASA physical status I-III

You may not qualify if:

• Known allergy to local anesthetics
• Chronic pain or regular opioid use
• Coagulopathy or anticoagulant therapy
• Local infection at the block site
• BMI more than 35 kg/m2
• Neurological or psychiatric disorders
• Refusal to participate

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, 63514, Egypt

RECRUITING

Related Publications (11)

• Asad U, Wang CF, Jones MW. Laparoscopic Cholecystectomy. 2025 Jul 2. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448145/

  PMID: 28846328 BACKGROUND

• Roy DK, Sheikh R. A Systematic Review and Meta-Analysis of the Outcomes of Laparoscopic Cholecystectomy Compared to the Open Procedure in Patients with Gallbladder Disease. Avicenna J Med. 2024 Feb 1;14(1):3-21. doi: 10.1055/s-0043-1777710. eCollection 2024 Jan.

  PMID: 38694141 BACKGROUND

• 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 BACKGROUND

• Dua A, Aziz A, Desai SS, McMaster J, Kuy S. National Trends in the Adoption of Laparoscopic Cholecystectomy over 7 Years in the United States and Impact of Laparoscopic Approaches Stratified by Age. Minim Invasive Surg. 2014;2014:635461. doi: 10.1155/2014/635461. Epub 2014 Mar 20.

  PMID: 24790759 BACKGROUND

• Urman RD, Khanna AK, Bergese SD, Buhre W, Wittmann M, Le Guen M, Overdyk FJ, Di Piazza F, Saager L. Postoperative opioid administration characteristics associated with opioid-induced respiratory depression: Results from the PRODIGY trial. J Clin Anesth. 2021 Jun;70:110167. doi: 10.1016/j.jclinane.2021.110167. Epub 2021 Jan 22.

  PMID: 33493688 BACKGROUND

• Lohmoller K, Carstensen V, Pogatzki-Zahn EM, Freys SM, Weibel S, Schnabel A. Regional anaesthesia for postoperative pain management following laparoscopic, visceral, non-oncological surgery a systematic review and meta-analysis. Surg Endosc. 2024 Apr;38(4):1844-1866. doi: 10.1007/s00464-023-10667-w. Epub 2024 Feb 2.

  PMID: 38307961 BACKGROUND

• Sethi D, Garg G. Evaluation of postoperative analgesia of erector spinae plane block in elective laparoscopic cholecystectomy: a randomized controlled trial. Turk J Anaesthesiol Reanim. 2021 Dec;49(6):432-438. doi: 10.5152/TJAR.2021.878.

  PMID: 35110021 BACKGROUND

• Altiparmak B, Korkmaz Toker M, Uysal AI, Kuscu Y, Gumus Demirbilek S. Ultrasound-guided erector spinae plane block versus oblique subcostal transversus abdominis plane block for postoperative analgesia of adult patients undergoing laparoscopic cholecystectomy: Randomized, controlled trial. J Clin Anesth. 2019 Nov;57:31-36. doi: 10.1016/j.jclinane.2019.03.012. Epub 2019 Mar 6.

  PMID: 30851501 BACKGROUND

• Yang X, Zhang Y, Chen Y, Xu M, Lei X, Fu Q. Analgesic effect of erector spinae plane block in adults undergoing laparoscopic cholecystectomy: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2023 Jan 6;23(1):7. doi: 10.1186/s12871-023-01969-6.

  PMID: 36609244 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Mohamed A Hamed, MD

  Faculty of medicine, Fayoum university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khaled M Sayed, Bch

CONTACT

1065444158; khaledm191170@gmail.com

Mohamed H Ragab, MD

CONTACT

1090050298; mhr02@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 22, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)