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Completed

NCT Number: NCT07018258

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Erector Spinae Plane (ESP) Block

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.

Other names: Ultrasound-guided ESP block

Primary outcomes

  1. Postoperative Pain Score (VAS)

    Time frame: 0, 2, 4, 6, 12, and 24 hours postoperatively

    Pain intensity will be assessed using the Visual Analog Scale (VAS, 0-10) at multiple time points following laparoscopic cholecystectomy. The goal is to compare postoperative pain scores between patient groups receiving ESP block in lateral, prone, or sitting positions.

Secondary outcomes

  1. Total Postoperative Analgesic Consumption

    Time frame: First 24 hours after surgery

    The cumulative dose (mg) of tramadol administered as rescue analgesia within the first 24 hours postoperatively will be recorded for each group.

  2. Time to First Analgesic Request

    Time frame: Within 24 hours postoperatively

    The duration (in minutes) between the end of surgery and the patient's first request for additional analgesia.

  3. Patient Satisfaction Score

    Time frame: 24 hours postoperatively

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

  4. Skin-to-Target Distance

    Time frame: During preoperative ESP block procedure

    The distance (in millimeters) from the skin to the ESP block site will be measured via ultrasound at the T7 level in each patient position to determine anatomical variation.

Sponsors and collaborators

Lead sponsor

Harran University

Other

Registry information

Official study title

Optimal Patient Positioning for Erector Spinae Plane Block: Effects on Postoperative Analgesia and Patient Satisfaction"

Acronym: ESP-POSTURE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 12, 2025
Registry last updated
Feb 27, 2026

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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