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Not yet recruiting NCT06900413

ESP vs. EXORA Blocks for Analgesia in Laparoscopic Cholecystectomy

No phase Interventional Erector Spinae Plane Block Laparoscopic Cholecystectomy Plane Block

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Group ESP, Group EXORA.
Who it may be relevant to
Registry conditions: Erector Spinae Plane Block, Laparoscopic Cholecystectomy, Plane Block. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of the Efficacy of Erector Spinae Plane (ESP) and External Oblique and Rectus Abdominis Plane (EXORA) Blocks in Laparoscopic Cholecystectomy

Overview

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.

Interventions

  • Procedure Group ESP
    Experienced anesthesiologists with at least five years of expertise in regional anesthesia will perform the blocks under ultrasound guidance. A 4.0-12.0 MHz linear ultrasound probe (Affiniti 50; Philips) will be used. The ESP block will be applied at the T8 level on the right side, using an in-plane approach, while the patient is in a sitting position. The probe will be placed 2-3 cm lateral to the vertebra in a sagittal position to visualize the erector spinae muscle and transverse processes.
  • Procedure Group EXORA
    Experienced anesthesiologists with at least five years of expertise in regional anesthesia will administer the blocks under ultrasound guidance. A 4.0-12.0 MHz linear ultrasound probe will be placed laterally to the xiphoid process on the parasternal line in a sagittal position. The probe will be moved craniocaudally to identify the 6th rib and further advanced caudally to locate the 8th rib. Once the rectus abdominis muscle and 8th costal cartilage are identified, a 22G, 100 mm block needle wil

Primary outcome measures

  • Tramadol consumption [Time frame: 12 and 24 hours]
Secondary outcome measures (5)
  • Visual Analog Scale (VAS) for Pain Assessment [Time frame: 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours after surgery]
  • Pinprick Sensory Block Test Results [Time frame: 10 minutes, 20 minutes, and 30 minutes after the block, and 30 minutes after surgery]
  • Nausea and Vomiting Score (NVS) [Time frame: Within 24 hours after surgery]
  • Ramsay Sedation Scale (RSS) [Time frame: Within 24 hours after surgery]
  • Additional Analgesic Consumption [Time frame: Within 24 hours after surgery]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06900413 · KSH-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗