ESP vs Subcostal TAP Block for Analgesia After Laparoscopic Cholecystectomy

NCT07661693 | Not Yet Recruiting

• 1 other identifier: BS-ESP-TAP-2026
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized, double-blind study compares the analgesic efficacy of ultrasound-guided erector spinae plane (ESP) block and subcostal transversus abdominis plane (TAP) block in patients undergoing laparoscopic cholecystectomy. The primary outcome is 24-hour postoperative opioid consumption. Secondary outcomes include postoperative pain scores, time to first analgesic request, shoulder pain, postoperative nausea and vomiting, and block-related complications.

Conditions

Cholelithiasis, Postoperative Pain, Laparoscopic Cholecystectomy

Keywords

ESP Block, TAP Block, Regional Anesthesia, Ultrasound, Laparoscopic Cholecystectomy, Postoperative Analgesia, Opioid Use

Outcome Measures

Primary Outcomes (1)

• Total Opioid Consumption in the First 24 Hours Postoperatively

  Total opioid consumption during the first 24 postoperative hours, converted to intravenous morphine equivalent dose (mg), recorded from patient-controlled analgesia devices and supplemental opioid administration.

  Within 24 hours after surgery

Study Arms (2)

Erector Spinae Plane Block

EXPERIMENTAL

Patients in this arm will receive ultrasound-guided bilateral erector spinae plane block following induction of general anesthesia. A standardized volume and concentration of local anesthetic will be administered at the appropriate thoracic level. All patients will receive standardized intraoperative anesthesia and postoperative multimodal analgesia.

Procedure: Erector Spinae Plane Block

Subcostal TAP Block

EXPERIMENTAL

Patients in this arm will receive ultrasound-guided bilateral subcostal transversus abdominis plane block following induction of general anesthesia. A standardized volume and concentration of local anesthetic will be administered. All patients will receive standardized intraoperative anesthesia and postoperative multimodal analgesia.

Procedure: Subcostal Transversus Abdominis Plane Block

Interventions

Erector Spinae Plane Block PROCEDURE

Ultrasound-guided bilateral erector spinae plane block will be performed after induction of general anesthesia. The block will be administered at the appropriate thoracic vertebral level using a standardized volume and concentration of local anesthetic deposited in the fascial plane deep to the erector spinae muscle. The procedure will be performed by experienced anesthesiologists under sterile conditions.

Erector Spinae Plane Block

Subcostal Transversus Abdominis Plane Block PROCEDURE

Ultrasound-guided bilateral subcostal transversus abdominis plane block will be performed after induction of general anesthesia. A standardized volume and concentration of local anesthetic will be injected into the fascial plane between the rectus abdominis and transversus abdominis muscles along the subcostal margin. The procedure will be performed by experienced anesthesiologists under sterile conditions.

Subcostal TAP Block

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years and older
• Scheduled for elective laparoscopic cholecystectomy under general anesthesia
• American Society of Anesthesiologists (ASA) physical status I-III
• Ability to understand the study protocol and provide written informed consent -

You may not qualify if:

• Known allergy or contraindication to local anesthetic agents
• Coagulopathy or anticoagulant therapy contraindicating regional anesthesia
• Infection at the planned injection site
• Body mass index (BMI) \> 35 kg/m²
• Chronic opioid use or opioid dependence
• Chronic pain syndromes requiring regular analgesic treatment
• Severe hepatic, renal, or cardiac dysfunction
• Pregnancy or breastfeeding
• Inability to communicate or assess pain using the Numerical Rating Scale (NRS)

Sponsors & Collaborators

• Gaziantep City Hospital: lead

Study Sites (1)

Gaziantep City Hospital

Şahinbey, Gaziantep, 27060, Turkey (Türkiye)

Location

Related Publications (1)

• This study will generate individual participant data (IPD) related to postoperative analgesia, including opioid consumption, pain scores, and block-related complications. Data will be de-identified prior to sharing. Access to IPD will be available upon reasonable request to the corresponding author after publication of the main study results. Data requests will require a signed data use agreement, specifying the purpose of analysis and acknowledgment of original investigators. Supporting documentation, including study protocol and statistical analysis plan, will also be provided to researchers granted access.

  BACKGROUND

MeSH Terms

Conditions

Cholelithiasis; Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Bekir Suat Kürkçüoğlu

  Gaziantep City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bekir Suat Kürkçüoğlu

CONTACT

05055830463; bekirsuat@gmail.com

Bekir Suat Kürkçüoğlu

CONTACT

+905055830463; bekirsuat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and postoperative outcome assessors will be blinded to group allocation. The regional block will be performed after induction of general anesthesia to maintain participant blinding. Postoperative pain assessments and data collection will be conducted by investigators who are unaware of the assigned intervention. The anesthesiologist performing the block will not be involved in postoperative outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Model Details: This study is a prospective, randomized, double-blind, parallel-group clinical trial. Eligible patients undergoing elective laparoscopic cholecystectomy under general anesthesia will be randomly assigned in a 1:1 ratio to receive either bilateral erector spinae plane block or bilateral subcostal transversus abdominis plane block. Randomization will be performed using a computer-generated sequence with allocation concealment. Patients and postoperative outcome assessors will be blinded to group assignment. Standardized intraoperative anesthesia and postoperative multimodal analgesia protocols will be applied in both groups.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): June 15, 2027
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)