Clinical trial NCT07018258: Optimal Patient Positioning for Erector Spinae Plane Block in Laparoscopic Cholecystectomy:
Official title: Optimal Patient Positioning for Erector Spinae Plane Block: Effects on Postoperative Analgesia and Patient Satisfaction"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Pain
Laparoscopic Cholecystectomy
Anesthesia, Regional
Pain Management
Keywords: Erector Spinae Plane Block
Patient Positioning
Ultrasound-Guided Regional Anesthesia
Lead sponsor: Harran University
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly assigned to receive ESP block in either the lateral, prone, or sitting position prior to laparoscopic cholecystectomy.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Postoperative Pain Score (VAS)
timeFrame: 0, 2, 4, 6, 12, and 24 hours postoperatively
Secondary outcomes:
measure: Total Postoperative Analgesic Consumption
timeFrame: First 24 hours after surgery
measure: Time to First Analgesic Request
timeFrame: Within 24 hours postoperatively
measure: Patient Satisfaction Score
timeFrame: 24 hours postoperatively
measure: Skin-to-Target Distance
timeFrame: During preoperative ESP block procedure
Other outcomes:
Locations:
Study officials:
affiliation: Harran University Faculty of Medicine, Department of Anesthesiology
name: Veli F Pehlivan, Asiss Prof
role: PRINCIPAL_INVESTIGATOR
References: