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) )

NCT07057934 | Completed

• 2 other identifiers: SBÜ-KLKH-AR-2024-ESPB-EOPB-012024/17/840-938
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Cholelithiasis; Acute Pain

Keywords

Laparoscopic Cholecystectomy; Regional Anesthesia; Erector Spinae Plane Block; External Oblique Intercostal Plane Block; Multimodal Analgesia

Outcome Measures

Primary Outcomes (2)

• Postoperative Pain Intensity (VAS Score)

  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).

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

• Total Rescue Analgesic Consumption (Dexketoprofen + Tramadol)

  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.

  0-24 hours postoperatively

Secondary Outcomes (4)

• Time to First Rescue Analgesic Requirement

  0-24 hours postoperatively

• Patient Satisfaction Score

  At 24 hours postoperatively

• Incidence of Block-Related Complications

  Intraoperative and within 24 hours postoperative

• Intraoperative Opioid Requirement

  Intraoperative period (during surgery)

Study Arms (3)

Erector Spinae Plane Block (ESPB)

EXPERIMENTAL

Participants in this group received a bilateral ultrasound-guided erector spinae plane block (ESPB) at the T7-T8 vertebral level under general anesthesia prior to surgical incision. 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.

Procedure: ESPB Block

External Oblique Intercostal Plane Block (EOPB)

EXPERIMENTAL

Participants in this group received an external oblique intercostal plane block (EOPB) under ultrasound guidance prior to surgical incision. 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.

Procedure: EOPB Block

Control Group

OTHER

Participants in this group did not receive any regional block. Postoperative analgesia was provided via standard systemic medications as needed. 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.

Drug: Standard Systemic Analgesia

Interventions

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.

Erector Spinae Plane Block (ESPB)

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.

External Oblique Intercostal Plane Block (EOPB)

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Aykutaydiniu@Gmail.Com

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Cholelithiasis; Acute Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The local anesthetic to be used in the study was prepared by two researchers who were not involved in the anesthesia application and did not participate in the postoperative data collection process. Postoperative patient data were recorded with the random ID assigned to each patient, and the researchers who collected data during this process were not informed about the patient groups. In addition, the anesthesiologist who performed the simple randomization also performed the nerve block, but was not involved in the collection of postoperative data. The anesthesiologists responsible for the anesthesia management and data collection process were not informed about the group distribution, and thus the study was conducted in a double-blind manner.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: This is a single-center, prospective, randomized, controlled, parallel-group clinical trial involving 90 patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Participants were randomly allocated into three groups: ESPB Group: Patients received a bilateral erector spinae plane block at the T7-T8 level prior to surgical incision. EOPB Group: Patients received an external oblique intercostal plane block at the 6th rib level. Control Group: Patients received no regional block. All participants were monitored for postoperative pain scores and analgesic consumption over 24 hours.

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 10, 2025
• Study Start: April 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)