RecruitingNot ApplicableNCT07241949

Regional Analgesia Techniques for Laparoscopic Cholecystectomy

Paravertebral Block or External Oblique Intercostal Block? A Comparative Analysis of Pain and Opioid Consumption After Laparoscopic Cholecystectomy: A Randomized Controlled Trial


Sponsor

Cukurova University

Enrollment

147 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This single-center, prospective, randomized controlled trial aims to compare the effects of paravertebral block (PVB), external oblique intercostal (EOI) block, and intravenous patient-controlled analgesia (PCA) with tramadol on postoperative pain and opioid consumption in patients undergoing elective laparoscopic cholecystectomy. The primary endpoint is total tramadol consumption within 24 hours postoperatively. Secondary outcomes include pain scores, additional analgesic use, incidence of nausea/vomiting, mobilization time, and length of hospital stay.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • Age between 18 and 65 years
  • Scheduled for elective laparoscopic cholecystectomy under general anesthesia
  • ASA physical status I-III
  • Able to understand the study procedure and provide informed consent

Exclusion Criteria10

  • Patient refusal or inability to provide informed consent
  • Allergy or contraindication to local anesthetics, tramadol, or study medications
  • Coagulopathy or current anticoagulant therapy
  • Local infection at the planned block injection site
  • Severe hepatic or renal impairment
  • Chronic opioid use or opioid dependence
  • Neurological or psychiatric disorders affecting pain perception or communication
  • Pregnancy or breastfeeding
  • Body mass index (BMI) > 35 kg/m²
  • Conversion to open cholecystectomy during surgery

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Interventions

PROCEDUREParavertebral Block (PVB)

Ultrasound-guided bilateral thoracic paravertebral block performed after induction of general anesthesia using 0.25% bupivacaine, 20 mL per side (total 40 mL).

PROCEDUREExternal Oblique Intercostal Block (EOI Block)

Ultrasound-guided bilateral external oblique intercostal block performed after induction of general anesthesia with 0.25% bupivacaine, 20 mL per side (total 40 mL), injected between the external oblique and intercostal muscles.

DRUGTramadol IV Patient-Controlled Analgesia (PCA)

Intravenous patient-controlled analgesia (PCA) programmed to deliver tramadol with a maximum dose of 400 mg in 24 hours. Standard analgesia protocol includes IV paracetamol 1 g every 8 hours.


Locations(1)

Cukurova University Faculty of Medicine

Adana, Turkey (Türkiye)

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NCT07241949


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