EXORA vs ESP Blocks in Laparoscopic Cholecystectomy

May 30, 2026 updated by: Mohamed Ahmed Hamed, Fayoum University Hospital

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

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 patients undergoing laparoscopic cholecystectomy and that the EXORA block analgesic profile is superior to that of the ESP block.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Following the tenets of the Declaration of Helsinki and the Consolidated Standards of Reporting Trials (CONSORT) 2025-updated statement, this prospective, randomized, double-blinded, controlled clinical trial will be conducted at Fayoum University Hospital (FUH) starting from October 2025 until the sample size is reached.

After obtaining approval from the local institutional ethics committee at Fayoum University Hospital (FUH) and registering the trial on ClinicalTrials.gov, all patients scheduled for elective cholecystectomy at FUH will sign a detailed informed consent form after fulfilling the eligibility criteria.

Patients will be randomly assigned to three equal groups with an allocation ratio of 1:1:1 (n=35) using computer-generated random numbers that will be sealed in a closed opaque envelope, opened by the anesthesiologist responsible for administering the ultrasound-guided block preoperatively

  • Group A (EXORA Block Group): Patients will receive bilateral EXORA blocks.
  • Group B (ESP Block Group): Patients will receive bilateral ESP blocks.
  • Group C (Control Group): patients will not receive any block, only standard care.

Preoperatively, all patients will be assessed and investigated by complete blood count, Prothrombin time and concentration, kidney and liver functions. Additional investigations, such as serum electrolytes, ECG, ECHO, etc., will be ordered upon individual patient assessment.

All blocks will be performed by an anesthesiologist experienced in regional blocks preoperatively in a separate block room under strict aseptic conditions using ultrasound guidance after applying standard monitoring (pulse oximetry, non-invasive blood pressure, and electrocardiogram) and administering a sedative dose of intravenous midazolam (0.03 mg/kg).

For both groups A and B, sensory block will be assessed by a blinded anesthesiologist after 30 minutes from the block maneuver bilaterally from the distribution of the fifth Thoracic dermatome (T5) down to the level of the twelfth thoracic dermatome (T12). This will be accomplished using a pinprick with a blunt 20-G needle on a two-point scale, where 0 indicates the presence of sensation and 1 indicates numbness or absence of sensation in reference to sensation in the shoulder region. If no sensory loss is observed, the patient will be excluded from the study.

All patients will then be transferred to the operating room, handed over to the attending anesthesiologist who is blinded to group allocation and is responsible for further patient management. standard monitoring will be reapplied, and then general anesthesia will be induced using propofol (2 mg/kg), atracurium (0.5 mg/kg), and fentanyl (2 μg/kg). Anesthesia will be maintained with intermittent intravenous atracurium (0.1 mg/kg boluses) and an isoflurane inhalation in an oxygen and air mixture. An intravenous Ketorolac (30 mg), Nalbuphine (10 mg), and Ondansetron 8 mg will be administered approximately 30 minutes before the end of the operation.

After discharge to the ward, paracetamol 1g /8 hours and ketorolac 30 mg/12 hours will be administered to all patients. Both static (at rest) and dynamic (with movement) visual analogue scale (VAS) will be assessed at 1,2, 4, 6, 12, and 24 hours (where 0 denotes no pain, and 10 represents the most intense pain ever experienced), and if the VAS score is equal to or higher than 4, a rescue analgesic dose of nalbuphine 5 mg will be administered.

Study Type

Interventional

Enrollment (Estimated)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Faiyum Governorate
      • El Fayoum Qesm, Faiyum Governorate, Egypt, 63514
        • Recruiting
        • Fayoum University hospital
        • Contact:
        • Principal Investigator:
          • Mohamed A Hamed
        • Sub-Investigator:
          • Mohamed H Ragab
        • Contact:
        • Sub-Investigator:
          • Mohamed A Shawky
        • Sub-Investigator:
          • Khaled M Sayed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Elective laparoscopic cholecystectomy
  • ASA physical status I-III

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EXORA block group
Group A (EXORA Block Group): Patients will receive bilateral EXORA blocks.
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.
Active Comparator: ESP block group
Group B (ESP Block Group): Patients will receive bilateral ESP blocks.
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.
No Intervention: control group
Group C (Control Group): patients will not receive any block, only standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total opioid consumption
Time Frame: Up to 24 hours after surgery
Post operative nalbuphine used in the first 24 hours in milligrams
Up to 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative Fentanyl consumption
Time Frame: From induction of anesthesia until patient is transferred to postoperative care unit up to 4 hours
Total fentanyl in milligrams
From induction of anesthesia until patient is transferred to postoperative care unit up to 4 hours
Time needed to complete the block
Time Frame: From start of block procedure up to 1 hour
In minutes
From start of block procedure up to 1 hour
Sensory block distribution level (pin-prick test)
Time Frame: after 30 minuets from the block maneuver bilaterally
sensory block will be assessed by a blinded anesthesiologist after 30 minutes from the block maneuver bilaterally from the distribution of the fifth Thoracic dermatome (T5) down to the level of the twelfth thoracic dermatome (T12). This will be accomplished using a pinprick with a blunt 20-G needle on a two-point scale, where 0 indicates the presence of sensation and 1 indicates numbness or absence of sensation in reference to sensation in the shoulder region.
after 30 minuets from the block maneuver bilaterally
Heart rate
Time Frame: Upon arrival to Operating Room until 24 hours postoperative
Heart rate (HR) recorded intra and post operative
Upon arrival to Operating Room until 24 hours postoperative
Blood pressure
Time Frame: Upon arrival to Operating Room until 24 hours postoperative
Mean Arterial Pressure (MAP)
Upon arrival to Operating Room until 24 hours postoperative
Rescue analgesia
Time Frame: Upon recovery from General anesthesia up to 24 h postoperatively
Time to first request of rescue analgesia
Upon recovery from General anesthesia up to 24 h postoperatively
Incidence of opioid-related side effects
Time Frame: From induction of anesthesia up to 24 h postoperatively
Assessment of each patient looking for any of the side effects of opioids as nausea, vomiting, sedation.
From induction of anesthesia up to 24 h postoperatively
Incidence of Block-related side effects
Time Frame: From the time just after giving the block up to 24 h postoperatively
any Block-related side effects as Local anesthetic systemic toxicity, bleeding, pneumothorax, local infection.
From the time just after giving the block up to 24 h postoperatively
Postoperative pain scores by Visual Analogue Scale (VAS)
Time Frame: From patient discharge to postoperative anesthesia care unit 24 hours postoperatively
score from 0 to 10 where 0 indicates no pain and 10 indicates the worst imaginable pain
From patient discharge to postoperative anesthesia care unit 24 hours postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of recovery (QoR-15)
Time Frame: At 24 hours postoperatively
scores range from 0 to 150, with a higher score indicating a better quality of postoperative recovery.
At 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University Hospital

Investigators

  • Principal Investigator: Mohamed A Hamed, MD, Faculty of medicine, Fayoum university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

September 18, 2025

First Submitted That Met QC Criteria

September 18, 2025

First Posted (Actual)

September 22, 2025

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 30, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M829

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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