NCT07018258

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

June 27, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2025

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

June 4, 2025

Last Update Submit

February 25, 2026

Conditions

Keywords

Erector Spinae Plane BlockPatient PositioningUltrasound-Guided Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Score (VAS)

    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.

    0, 2, 4, 6, 12, and 24 hours postoperatively

Secondary Outcomes (4)

  • Total Postoperative Analgesic Consumption

    First 24 hours after surgery

  • Time to First Analgesic Request

    Within 24 hours postoperatively

  • Patient Satisfaction Score

    24 hours postoperatively

  • Skin-to-Target Distance

    During preoperative ESP block procedure

Study Arms (3)

Lateral Position Group

EXPERIMENTAL

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.

Procedure: Erector Spinae Plane (ESP) Block

Prone Position Group

EXPERIMENTAL

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.

Procedure: Erector Spinae Plane (ESP) Block

Sitting Position Group

EXPERIMENTAL

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.

Procedure: Erector Spinae Plane (ESP) Block

Interventions

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.

Also known as: Ultrasound-guided ESP block
Lateral Position GroupProne Position GroupSitting Position Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veli Fahri Pehlivan

Sanliurfa, 63100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Interventions

ParapsychologyDental Occlusion

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Behavioral SciencesBehavioral Disciplines and ActivitiesDentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Veli F Pehlivan, Asiss Prof

    Harran University Faculty of Medicine, Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The person evaluating postoperative pain scores and satisfaction will be blinded to group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomly assigned to receive ESP block in either the lateral, prone, or sitting position prior to laparoscopic cholecystectomy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 4, 2025

First Posted

June 12, 2025

Study Start

June 27, 2025

Primary Completion

November 10, 2025

Study Completion

December 10, 2025

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations