Optimal Patient Positioning for Erector Spinae Plane Block in Laparoscopic Cholecystectomy:

NCT ID: NCT07018258

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-27
• Study Completion Date: 2025-12-10

Brief Summary

This randomized clinical study aims to compare the postoperative analgesic efficacy, analgesic consumption, and patient satisfaction of erector spinae plane (ESP) block administered in three different patient positions-lateral, prone, and sitting-in individuals undergoing elective laparoscopic cholecystectomy. The study also evaluates the variation in skin-to-block site distance depending on patient positioning.

Detailed Description

Erector spinae plane (ESP) block is a relatively recent regional anesthesia technique performed under ultrasound guidance, widely used for managing acute postoperative pain. While the ESP block is known for its safety, simplicity, and versatility, there is limited evidence regarding the influence of patient positioning on its clinical effectiveness and technical performance.

This prospective, randomized, single-blind study investigates the impact of administering bilateral ESP block at the T7 vertebral level in three different patient positions: lateral decubitus, prone, and sitting. The study includes adult patients (aged 18-65, ASA I-II) undergoing elective laparoscopic cholecystectomy under general anesthesia.

Primary outcomes include postoperative pain scores (VAS and NRS). Secondary outcomes include total rescue analgesic consumption (tramadol), time to first analgesic requirement, patient satisfaction scores (Likert scale), and measurement of the skin-to-block site distance across different positions. Data will be collected at defined intervals up to 24 hours postoperatively.

The findings are expected to inform clinicians on the optimal patient positioning for ESP block to enhance block efficacy and patient comfort during laparoscopic abdominal surgery.

Conditions

Postoperative Pain; Laparoscopic Cholecystectomy; Anesthesia, Regional; Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lateral Position Group

Patients in this group will receive bilateral erector spinae plane (ESP) block at the T7 level in the lateral decubitus position under ultrasound guidance before laparoscopic cholecystectomy.

Group Type: EXPERIMENTAL

Erector Spinae Plane (ESP) Block

Intervention Type: PROCEDURE

Ultrasound-guided bilateral erector spinae plane (ESP) block performed at the T7 vertebral level. The intervention will be applied in three different patient positions-lateral, prone, or sitting-prior to laparoscopic cholecystectomy.

Prone Position Group

Patients in this group will receive bilateral erector spinae plane (ESP) block at the T7 level in the lateral decubitus position under ultrasound guidance before laparoscopic cholecystectomy.

Group Type: EXPERIMENTAL

Erector Spinae Plane (ESP) Block

Intervention Type: PROCEDURE

Ultrasound-guided bilateral erector spinae plane (ESP) block performed at the T7 vertebral level. The intervention will be applied in three different patient positions-lateral, prone, or sitting-prior to laparoscopic cholecystectomy.

Sitting Position Group

Patients in this group will receive bilateral erector spinae plane (ESP) block at the T7 level in the lateral decubitus position under ultrasound guidance before laparoscopic cholecystectomy.

Group Type: EXPERIMENTAL

Erector Spinae Plane (ESP) Block

Intervention Type: PROCEDURE

Ultrasound-guided bilateral erector spinae plane (ESP) block performed at the T7 vertebral level. The intervention will be applied in three different patient positions-lateral, prone, or sitting-prior to laparoscopic cholecystectomy.

Interventions

Erector Spinae Plane (ESP) Block

Ultrasound-guided bilateral erector spinae plane (ESP) block performed at the T7 vertebral level. The intervention will be applied in three different patient positions-lateral, prone, or sitting-prior to laparoscopic cholecystectomy.

Intervention Type: PROCEDURE

Other Intervention Names

Ultrasound-guided ESP block

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 65 years
• Scheduled for elective laparoscopic cholecystectomy
• ASA physical status I-II
• Ability to understand and provide written informed consent

Exclusion Criteria

• Allergy to local anesthetics
• History of chronic opioid use or substance abuse
• Coagulopathy or current anticoagulant therapy
• Local infection at the block site
• Severe spinal deformities or scoliosis
• BMI > 35 kg/m²
• Pregnancy or breastfeeding
• Refusal to participate in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harran University

OTHER

Sponsor Role: lead

Responsible Party

Veli Fahri Pehlivan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Veli F Pehlivan, Asiss Prof

Role: PRINCIPAL_INVESTIGATOR

Harran University Faculty of Medicine, Department of Anesthesiology

Locations

Veli Fahri Pehlivan

Sanliurfa, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Veli F Pehlivan, Asiss Prof

Role: CONTACT

vfpehlivan@harran.edu.tr

+905327696566

Cevher Akar, Dr

Role: CONTACT

mdcevherakar@gmail.com

+905446036040

Facility Contacts

Veli Fahri Pehlivan, Asisst Prof

Role: primary

vfpehlivan@harran.edu.tr

05327696566

Other Identifiers

Cevher

Identifier Type: -

Identifier Source: org_study_id