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RECRUITING
NCT07187310
NA

EXORA vs ESP Blocks in Laparoscopic Cholecystectomy

Sponsor: Fayoum University Hospital

View on ClinicalTrials.gov

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.

Official title: The Analgesic Efficacy of EXORA Block Versus Erector Spinae Plane Block in Patients Undergoing Laparoscopic Cholecystectomy Under General Anesthesia

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2025-12-30

Completion Date

2026-04-01

Last Updated

2025-12-31

Healthy Volunteers

No

Interventions

PROCEDURE

EXORA block

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.

PROCEDURE

Erector Spinae Plane block

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.

Locations (1)

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, Egypt