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Completed

NCT Number: NCT07057934

Comparative Efficacy of ESPB and EOPB for Postoperative Analgesia in Laparoscopic Cholecystectomy: A Randomized Controlled Trial (External Oblique Intercostal Plan Block (EOPB) and Erector Spina Plan Block (ESPB) )

This randomized controlled clinical trial investigates the comparative efficacy of two novel regional anesthesia techniques - the Erector Spinae Plane Block (ESPB) and the External Oblique Intercostal Plane Block (EOPB) - for postoperative analgesia in patients undergoing elective laparoscopic cholecystectomy under general anesthesia.

A total of 90 patients aged 18-65 years, with ASA physical status I or II, were randomly assigned to one of three groups: ESPB, EOPB, or control. Blocks were performed under ultrasound guidance prior to surgical incision. Pain intensity was evaluated using the Visual Analog Scale (VAS), and rescue analgesic consumption was recorded over the first 24 hours postoperatively.

The study aims to determine whether ESPB or EOPB offers superior pain control and reduced opioid consumption, and to assess patient satisfaction and safety. The results will inform multimodal analgesia strategies for upper abdominal laparoscopic surgery.

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Key information

About this study

Laparoscopic cholecystectomy (LC) is one of the most commonly performed upper abdominal surgeries. Despite being minimally invasive, LC is frequently associated with significant postoperative pain originating from both visceral and somatic sources. Inadequate pain control may lead to delayed recovery, increased opioid consumption, and patient dissatisfaction.

Regional anesthesia techniques have become increasingly important components of multimodal analgesia protocols for abdominal surgeries. Two recently described fascial plane blocks - the Erector Spinae Plane Block (ESPB) and the External Oblique Intercostal Plane Block (EOPB) - have shown promising results in reducing postoperative pain in thoracic and abdominal procedures.

This prospective, randomized, controlled clinical trial was conducted to evaluate and compare the analgesic effectiveness of ESPB and EOPB in patients undergoing elective LC under general anesthesia. After obtaining ethical approval (Protocol No: 2024/17/840-938) and informed consent, 90 adult patients aged 18-65 years with ASA physical status I or II were enrolled.

Participants were randomized into three groups using a sealed envelope technique:

Group 1 (ESPB): Received bilateral ultrasound-guided ESPB at the T7-8 level using 20 mL of local anesthetic solution (10 mL 0.5% bupivacaine + 10 mL 2% lidocaine) preoperatively.

Group 2 (EOPB): Received ultrasound-guided EOPB using the same volume and mixture of local anesthetic.

Group 3 (Control): Did not receive any regional block.

Postoperative pain was assessed using the Visual Analog Scale (VAS) at regular intervals (15 minutes, and at 2, 4, 8, 12, 16, and 24 hours). Rescue analgesia consisted of 50 mg dexketoprofen trometamol administered when VAS ≥4. If pain persisted, 50 mg tramadol was given as a second-line analgesic.

Primary endpoints included postoperative VAS scores and total rescue analgesic consumption over 24 hours. Secondary endpoints included time to first analgesic requirement, side effects, complications related to blocks, and patient satisfaction.

Initial results indicated that both ESPB and EOPB significantly reduced postoperative pain and analgesic requirements compared to the control group. While EOPB was technically easier to perform, ESPB provided longer-lasting analgesia. These findings may support the integration of ESPB or EOPB into routine multimodal analgesia protocols for laparoscopic abdominal surgeries.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-65 years
  • ASA physical status I-II
  • Undergoing elective laparoscopic cholecystectomy under general anesthesia
  • Provided informed written consent
  • BMI between 18.5 and 30 kg/m²
  • Able to follow study instructions

Exclusion criteria

  • Allergy to local anesthetics
  • Chronic opioid use or chronic pain
  • Coagulopathy or anticoagulant use
  • Severe organ dysfunction
  • Pregnancy or breastfeeding
  • Neurological or psychiatric disorders
  • Infection at injection site
  • Refusal to participate

Treatment and study plan

ESPB Block

Procedure

Under sterile conditions and ultrasound guidance, 20 mL of local anesthetic solution (10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine) was injected bilaterally into the erector spinae plane at the T7-T8 level before incision. The block was performed after induction of general anesthesia but before the start of laparoscopic cholecystectomy.

EOPB Block

Procedure

Under ultrasound guidance, 20 mL of local anesthetic mixture (10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine) was injected into the fascial plane between the external oblique and internal intercostal muscles at the level of the 6th rib. The procedure was done after anesthesia induction but prior to laparoscopic cholecystectomy.

Standard Systemic Analgesia

Drug

No regional anesthesia technique was applied. Postoperative pain was managed using systemic rescue analgesia: 50 mg dexketoprofen trometamol IV when VAS ≥4, followed by 50 mg tramadol IV if pain persisted.

Primary outcomes

  1. Postoperative Pain Intensity (VAS Score)

    Time frame: 0-24 hours postoperatively (measured at 15 min, 2, 4, 8, 12, 16, and 24 hours)

    Postoperative pain will be measured using the Visual Analog Scale (VAS), where patients rate their pain on a 0-10 scale (0 = no pain, 10 = worst imaginable pain).

  2. Total Rescue Analgesic Consumption (Dexketoprofen + Tramadol)

    Time frame: 0-24 hours postoperatively

    Total cumulative dose of rescue analgesics administered within the first 24 hours postoperatively will be recorded. Dexketoprofen (mg) and tramadol (mg) will be summed for each participant.

Secondary outcomes

  1. Time to First Rescue Analgesic Requirement

    Time frame: 0-24 hours postoperatively

    The time elapsed from the end of surgery to the administration of the first dose of rescue analgesic (dexketoprofen) will be recorded for each participant.

  2. Patient Satisfaction Score

    Time frame: At 24 hours postoperatively

    Patient satisfaction with pain management will be assessed at 24 hours using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).

  3. Incidence of Block-Related Complications

    Time frame: Intraoperative and within 24 hours postoperative

    Incidence of complications related to regional blocks (e.g., local anesthetic toxicity, hematoma, nerve injury, pneumothorax) will be monitored and recorded.

  4. Intraoperative Opioid Requirement

    Time frame: Intraoperative period (during surgery)

    Total intraoperative fentanyl dose (in mcg) administered during the procedure will be recorded.

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Official study title

THE EFFECTS OF EXTERNAL OBLIQUE INTERCOSTAL PLAN BLOCK AND ERECTOR SPINA PLAN BLOCK ON POSTOPERATIVE ANALGESIA IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY OPERATION

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2025
Registry last updated
Jul 10, 2025

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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