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Not yet recruiting NCT07533279

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

No phase Interventional Cholecystectomy Postoperative Pain Erector Spinae Plane Block Regional Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Erector Spinae Plane Block, External Oblique Intercostal Plane Block.
Who it may be relevant to
Registry conditions: Cholecystectomy, Postoperative Pain, Erector Spinae Plane Block, Regional Anesthesia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Detailed description

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.

Interventions

  • Procedure Erector Spinae Plane Block
    Bilateral erector spinae plane block will be performed under ultrasound guidance using local anesthetic prior to surgical incision to provide postoperative analgesia.
  • Procedure External Oblique Intercostal Plane Block
    Bilateral external oblique intercostal plane block will be performed under ultrasound guidance using local anesthetic prior to surgical incision to provide postoperative analgesia.

Primary outcome measures

  • Postoperative Pain Score (VAS) [Time frame: Within the first 24 hours postoperatively]
Secondary outcome measures (3)
  • Total Opioid Consumption [Time frame: First 24 hours postoperatively]
  • Time to First Analgesic Request [Time frame: Within 24 hours postoperatively]
  • Postoperative Complications [Time frame: Within 24 hours postoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07533279 · MD-37-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗