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NCT Number: NCT07533279

Erector Spinae Plane Block Versus External Oblique Intercostal Plane Block for Analgesia in Open Cholecystectomy

This randomized controlled trial aims to compare the analgesic efficacy of bilateral ultrasound-guided erector spinae plane block (ESPB) versus bilateral external oblique intercostal plane (EOI) block in patients undergoing open cholecystectomy.

Patients will be randomly allocated into two groups to receive either ESPB or EOI block in addition to standard general anesthesia. The primary outcome is postoperative pain score assessed using the Numerical Rating Scale (NRS) at 2 hours after surgery. Secondary outcomes include intraoperative opioid consumption, postoperative nalbuphine requirements, time to first analgesic request, and hemodynamic changes.

This study seeks to determine the more effective regional anesthesia technique for improving perioperative analgesia in open cholecystectomy.

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Key information

Conditions

Cholecystectomy Erector Spinae Plane Block Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Regional Anesthesia Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Open cholecystectomy is still indicated in selected patients such as those with complicated gallbladder disease or contraindications to laparoscopy. Effective perioperative pain management is essential to improve patient outcomes and reduce opioid consumption.

Regional anesthesia techniques have gained increasing interest, particularly with the use of ultrasound guidance. The erector spinae plane block (ESPB) is a relatively simple and widely used interfascial block that provides effective analgesia for abdominal surgeries. The external oblique intercostal plane (EOI) block is a newer technique targeting the upper abdominal wall.

In this prospective, randomized, double-blinded clinical trial, adult patients undergoing elective open cholecystectomy will be randomized into two groups. One group will receive bilateral ultrasound-guided ESPB, while the other group will receive bilateral ultrasound-guided EOI block, both performed after induction of general anesthesia and before surgical incision.

All patients will receive standardized general anesthesia. Pain will be assessed using the Numerical Rating Scale (NRS) at multiple time points postoperatively. Rescue analgesia with intravenous nalbuphine will be administered as needed.

The primary outcome is postoperative pain score at 2 hours. Secondary outcomes include intraoperative fentanyl consumption, total nalbuphine consumption over 24 hours, time to first analgesic request, hemodynamic parameters, and any block-related complications.

This study aims to provide evidence regarding the comparative effectiveness of ESPB and EOI block in open cholecystectomy surgeries.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients aged 18-65 years.
  • Patients scheduled for elective open cholecystectomy.
  • American Society of Anesthesiologists (ASA) physical status I-II.
  • Patients who provide informed consent.

Exclusion criteria

  • Patient refusal.
  • Known allergy to local anesthetics.
  • Coagulopathy or anticoagulant therapy.
  • Infection at the site of injection.
  • Severe hepatic, renal, or cardiac disease.
  • Body mass index (BMI) > 35 kg/m².
  • Pregnancy.

Treatment and study plan

Erector Spinae Plane Block

Procedure

Bilateral erector spinae plane block will be performed under ultrasound guidance using local anesthetic prior to surgical incision to provide postoperative analgesia.

External Oblique Intercostal Plane Block

Procedure

Bilateral external oblique intercostal plane block will be performed under ultrasound guidance using local anesthetic prior to surgical incision to provide postoperative analgesia.

Primary outcomes

  1. Postoperative Pain Score (VAS)

    Time frame: Within the first 24 hours postoperatively

    Postoperative pain will be assessed using the Visual Analog Scale (VAS) at rest and during movement.

Secondary outcomes

  1. Total Opioid Consumption

    Time frame: First 24 hours postoperatively

    Total opioid consumption in the first 24 hours after surgery measured in morphine equivalents.

  2. Time to First Analgesic Request

    Time frame: Within 24 hours postoperatively

    Time elapsed from the end of surgery to the first request for analgesia.

  3. Postoperative Complications

    Time frame: Within 24 hours postoperatively

    Incidence of postoperative complications including nausea, vomiting, and respiratory complications.

Study contacts

Contact information is provided by the study sponsor or research team.

Khaled M Hassan mohamed, MD

CONTACT

[email protected]

01153564555

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Collaborators

  • Cairo University

Registry information

Official study title

Efficacy of Bilateral Erector Spinae Plane Block Versus Bilateral External Oblique Intercostal Plane Block for Perioperative Analgesia in Open Cholecystectomy Surgeries: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 16, 2026
Registry last updated
Apr 16, 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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