Clinical trial NCT06900413: ESP vs. EXORA Blocks for Analgesia in Laparoscopic Cholecystectomy
Official title: Comparison of the Efficacy of Erector Spinae Plane (ESP) and External Oblique and Rectus Abdominis Plane (EXORA) Blocks in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Erector Spinae Plane Block
Laparoscopic Cholecystectomy
Plane Block
Keywords: Erector Spinae Plane Block
exora block
laparoscopic cholecystectomy
patient-controlled analgesia
plane block
Lead sponsor: Kutahya City Hospital
Sponsor class: OTHER
Collaborators: name: Kutahya City Hospital
First posted: 2025-03-28
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: Tramadol consumption
timeFrame: 12 and 24 hours
Secondary outcomes:
measure: Visual Analog Scale (VAS) for Pain Assessment
timeFrame: 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours after surgery
measure: Pinprick Sensory Block Test Results
timeFrame: 10 minutes, 20 minutes, and 30 minutes after the block, and 30 minutes after surgery
measure: Nausea and Vomiting Score (NVS)
timeFrame: Within 24 hours after surgery
measure: Ramsay Sedation Scale (RSS)
timeFrame: Within 24 hours after surgery
measure: Additional Analgesic Consumption
timeFrame: Within 24 hours after surgery
Other outcomes:
measure: Total Antiemetic Consumption
timeFrame: Within 24 hours after surgery
Locations:
Study officials:
affiliation: Kütahya City Hospital
name: Aycan KURTARANGİL DOĞAN
role: PRINCIPAL_INVESTIGATOR
affiliation: Kütahya City Hospital
name: Ali Kaynak
role: PRINCIPAL_INVESTIGATOR
References: