ESP vs. EXORA Blocks for Analgesia in Laparoscopic Cholecystectomy

Not Applicable

Not yet recruiting

• Conditions: Erector Spinae Plane Block; Laparoscopic Cholecystectomy; Plane Block

• Registration Number: NCT06900413
• Lead Sponsor: Aycan KURTARANGİL DOĞAN

Brief Summary

Patients undergoing laparoscopic cholecystectomy may experience moderate to severe postoperative pain. Effective postoperative analgesia enhances patient comfort and accelerates recovery. This study aims to compare the effects of Erector Spinae Plane (ESP) and External Oblique and Rectus Abdominis Plane (EXORA) blocks on postoperative pain management and analgesic consumption.

The study is designed as a prospective, randomized, double-blind trial. Patients will be randomly assigned to groups, and both practitioners and evaluators will be blinded to group assignments. Our hypothesis is that the EXORA block will provide superior analgesia and require less analgesic consumption compared to the ESP block. The results will be assessed in terms of postoperative pain management, patient comfort, and additional analgesic requirements.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-27
• Study First Posted: 2025-03-28
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-26
• Study Start: 2025-09-01
• Last Update Posted: 2025-09-03
• Primary Completion: 2026-03
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Age between 18 and 65 years

Undergoing elective laparoscopic cholecystectomy

Classified as American Society of Anesthesiologists (ASA) physical status I to III

Providing written informed consent

Exclusion Criteria

Known allergy or hypersensitivity to local anesthetics

Infection or skin lesions at the site of block application

Emergency surgical procedures

Refusal to participate in the study

Uncontrolled arterial hypertension

Uncontrolled diabetes mellitus

Mental retardation

Current use of antidepressant medications

Presence of metabolic disorders

Known bleeding diathesis

Morbid obesity (Body Mass Index > 40 kg/m²)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tramadol consumption	12 and 24 hours	Total tramadol used in the first 12 and 24 hours postoperatively.

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) for Pain Assessment	30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours after surgery	Postoperative pain will be assessed using the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate a worse outcome (more pain). Units on a scale (0-10)
Pinprick Sensory Block Test Results	10 minutes, 20 minutes, and 30 minutes after the block, and 30 minutes after surgery	Sensory block efficacy will be evaluated using the pinprick test at specified time intervals. The presence or absence of sensory block will be recorded. Binary (Block present / Block absent)
Nausea and Vomiting Score (NVS)	Within 24 hours after surgery	Postoperative nausea and vomiting will be evaluated using the Nausea and Vomiting Scale (NVS), which includes: 1. = No nausea,; 2. = Mild nausea,; 3. = Severe nausea,; 4. = Vomiting present. Higher scores indicate a worse outcome. Units on a scale (1-4)
Ramsay Sedation Scale (RSS)	Within 24 hours after surgery	Postoperative sedation will be assessed using the Ramsay Sedation Scale (RSS), which includes: 1. = Anxious, agitated, or restless; 2. = Cooperative, oriented, and tranquil; 3. = Responds to commands only; 4. = Brisk response to auditory stimulus; 5. = Sluggish response to auditory stimulus; 6. = No response Higher scores indicate a deeper level of sedation. Units on a scale (1-6)
Additional Analgesic Consumption	Within 24 hours after surgery	The total amount of additional analgesics administered postoperatively will be recorded. Milligrams (mg)