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Completed

NCT Number: NCT06900413

ESP vs. EXORA Blocks for Analgesia in Laparoscopic Cholecystectomy

Patients undergoing laparoscopic cholecystectomy may experience moderate to severe postoperative pain. Effective postoperative analgesia enhances patient comfort and accelerates recovery. This study aims to compare the effects of Erector Spinae Plane (ESP) and External Oblique and Rectus Abdominis Plane (EXORA) blocks on postoperative pain management and analgesic consumption.

The study is designed as a prospective, randomized, double-blind trial. Patients will be randomly assigned to groups, and both practitioners and evaluators will be blinded to group assignments. Our hypothesis is that the EXORA block will provide superior analgesia and require less analgesic consumption compared to the ESP block. The results will be assessed in terms of postoperative pain management, patient comfort, and additional analgesic requirements.

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Key information

Conditions

Erector Spinae Plane Block Laparoscopic Cholecystectomy Plane Block

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kütahya City Hospital

Kütahya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age between 18 and 65 years

Undergoing elective laparoscopic cholecystectomy

Classified as American Society of Anesthesiologists (ASA) physical status I to III

Providing written informed consent

Exclusion criteria

Known allergy or hypersensitivity to local anesthetics

Infection or skin lesions at the site of block application

Emergency surgical procedures

Refusal to participate in the study

Uncontrolled arterial hypertension

Uncontrolled diabetes mellitus

Mental retardation

Current use of antidepressant medications

Presence of metabolic disorders

Known bleeding diathesis

Morbid obesity (Body Mass Index > 40 kg/m²)

Treatment and study plan

group ESP

Procedure

Experienced anesthesiologists with at least five years of expertise in regional anesthesia will perform the blocks under ultrasound guidance. A 4.0-12.0 MHz linear ultrasound probe (Affiniti 50; Philips) will be used. The ESP block will be applied at the T8 level on the right side, using an in-plane approach, while the patient is in a sitting position. The probe will be placed 2-3 cm lateral to the vertebra in a sagittal position to visualize the erector spinae muscle and transverse processes.

A 22G, 100 mm block needle (Stimuplex® Ultra, Braun, Germany) will be advanced in a craniocaudal direction. The correct needle position will be confirmed by injecting 0.5-1 mL of isotonic NaCl and observing the spread via hydrodissection. Finally, 0.3 mL/kg of 0.25% bupivacaine will be administered, ensuring cranial and caudal spread of the local anesthetic.

Group EXORA

Procedure

Experienced anesthesiologists with at least five years of expertise in regional anesthesia will administer the blocks under ultrasound guidance. A 4.0-12.0 MHz linear ultrasound probe will be placed laterally to the xiphoid process on the parasternal line in a sagittal position. The probe will be moved craniocaudally to identify the 6th rib and further advanced caudally to locate the 8th rib. Once the rectus abdominis muscle and 8th costal cartilage are identified, a 22G, 100 mm block needle will be used to administer 0.3 mL/kg of 0.25% bupivacaine. The correct spread of the local anesthetic will be confirmed via ultrasound.

Primary outcomes

  1. Tramadol consumption

    Time frame: 12 and 24 hours

    Total tramadol used in the first 12 and 24 hours postoperatively.

Secondary outcomes

  1. Visual Analog Scale (VAS) for Pain Assessment

    Time frame: 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours after surgery

    Postoperative pain will be assessed using the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate a worse outcome (more pain). Units on a scale (0-10)

  2. Pinprick Sensory Block Test Results

    Time frame: 10 minutes, 20 minutes, and 30 minutes after the block, and 30 minutes after surgery

    Sensory block efficacy will be evaluated using the pinprick test at specified time intervals. The presence or absence of sensory block will be recorded. Binary (Block present / Block absent)

  3. Nausea and Vomiting Score (NVS)

    Time frame: Within 24 hours after surgery

    Postoperative nausea and vomiting will be evaluated using the Nausea and Vomiting Scale (NVS), which includes:

    • = No nausea,
    • = Mild nausea,
    • = Severe nausea,
    • = Vomiting present. Higher scores indicate a worse outcome. Units on a scale (1-4)

  4. Ramsay Sedation Scale (RSS)

    Time frame: Within 24 hours after surgery

    Postoperative sedation will be assessed using the Ramsay Sedation Scale (RSS), which includes:

    • = Anxious, agitated, or restless
    • = Cooperative, oriented, and tranquil
    • = Responds to commands only
    • = Brisk response to auditory stimulus
    • = Sluggish response to auditory stimulus
    • = No response Higher scores indicate a deeper level of sedation. Units on a scale (1-6)

  5. Additional Analgesic Consumption

    Time frame: Within 24 hours after surgery

    The total amount of additional analgesics administered postoperatively will be recorded. Milligrams (mg)

Other outcomes

  1. Total Antiemetic Consumption

    Time frame: Within 24 hours after surgery

    The total amount of antiemetic medication administered within 24 hours postoperatively will be recorded. Milligrams (mg)

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Sponsors and collaborators

Lead sponsor

Aycan KURTARANGİL DOĞAN

Other

Collaborators

  • Kutahya City Hospital

Registry information

Official study title

Comparison of the Efficacy of Erector Spinae Plane (ESP) and External Oblique and Rectus Abdominis Plane (EXORA) Blocks in Laparoscopic Cholecystectomy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 28, 2025
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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