Regional Analgesia Techniques for Laparoscopic Cholecystectomy (PVB-EOI-PCA)

May 10, 2026 updated by: Nurefsan Sadikoglu, Cukurova University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This single center, prospective, randomised controlled clinical trial is designed to evaluate analgesic efficacy and opioid sparing effect of ultrasound guided paravertebral block (PVB) and external oblique intercostal (EOI) block versus systemic opioid based analgesia in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia.

Pain after laparoscopic cholecystectomy is often moderate to severe during the first 24 hours , and has somatic and visceral components . Regional approaches that target thoracoabdominal dermatomes and visceral afferents may provide superior analgesia, allow for earlier mobilisation, and reduce opioid-related adverse effects compared with intravenous opioid regimens alone. PVB provides unilateral segmental blockade at thoracic paravertebral level, while the EOI block deposits local anaesthetic in the fascial plane between the external oblique and intercostal muscles, with spread to relevant thoracoabdominal nerves.

In a parallel-group design, participants will be randomly allocated to bilateral thoracic PVB, bilateral EOI block or no truncal block with standard systemic analgesia. All regional blocks will be performed under ultrasound guidance after induction of general anaesthesia. Standardised volumes and concentrations of long-acting local anaesthetic will be used according to institutional practice. The control group will receive patient-controlled intravenous opioid analgesia as part of a multimodal approach.

Standardisation of intraoperative monitoring and technique of general anaesthesia according to departmental protocols will be done for perioperative anaesthetic management. Postoperative pain intensity will be assessed by an 11-point Numerical Rating Scale at specified time points during the first 24 hours. Rescue analgesia will be administered according to a predefined algorithm. The trial's purpose is to compare postoperative opioid use between groups and to investigate differences in pain trajectories and opioid-related adverse events in routine clinical conditions.

Study Type

Interventional

Enrollment (Estimated)

147

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Paravertebral Block Group
Participants in this arm will receive bilateral paravertebral block after induction of general anesthesia. Under ultrasound guidance, 0.25% bupivacaine (20 mL per side; total 40 mL) will be administered to provide postoperative analgesia following laparoscopic cholecystectomy. Patients will also receive standard intravenous paracetamol postoperatively.
Procedure: Paravertebral 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).
Active Comparator: External Oblique Intercostal Block Group
Participants in this arm will receive bilateral external oblique intercostal (EOI) block after induction of general anesthesia. Under ultrasound guidance, 0.25% bupivacaine (20 mL per side; total 40 mL) will be injected into the fascial plane between the external oblique and intercostal muscles. Standard intravenous paracetamol will be administered postoperatively.
Procedure: External 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.
Active Comparator: Control Group - IV PCA Tramadol
Participants in this arm will receive intravenous patient-controlled analgesia (PCA) with tramadol for postoperative pain management. The PCA pump will be set to a maximum dose of 400 mg tramadol in 24 hours. Standard intravenous paracetamol (1 g every 8 hours) will also be administered. No regional anesthesia block will be performed in this group.
Drug: Tramadol 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.
Other Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour postoperative tramadol consumption
Time Frame: Within the first 24 hours after surgery.
Total amount of intravenous tramadol administered via PCA within the first 24 hours after surgery.
Within the first 24 hours after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative nausea and vomiting
Time Frame: Within 24 hours postoperatively
Presence of nausea and/or vomiting requiring antiemetic treatment.
Within 24 hours postoperatively
Incidence of block-related complications
Time Frame: Intraoperative and first 24 hours after block
Presence of complications related to the regional block (e.g., vascular puncture, pneumothorax, local anesthetic systemic toxicity).
Intraoperative and first 24 hours after block
Patient satisfaction with analgesia
Time Frame: 24 hours postoperatively
Patient-reported satisfaction score for pain management (0 = very dissatisfied, 10 = very satisfied).
24 hours postoperatively
Postoperative pain scores at rest
Time Frame: 1, 6, 12, and 24 hours postoperatively
Postoperative pain intensity at rest will be assessed using the 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain), where higher scores indicate more severe pain.
1, 6, 12, and 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Investigators

  • Principal Investigator: Nurefsan Sadikoglu, MD, Cukurova University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 5, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 10, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pending-EC-2025-NSadikoglu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) that underlie the results reported in publications (de-identified dataset including primary and secondary outcome variables) will be shared. No information that could identify participants will be included. Data dictionaries and statistical codes may also be made available upon reasonable request for academic and research purposes. Access will be granted after publication and following institutional data-sharing agreements.

IPD Sharing Time Frame

De-identified individual participant data will be available beginning 6-12 months after publication of the primary results and for a period of up to 3 years thereafter.

IPD Sharing Access Criteria

Researchers seeking access to the data will be required to submit a methodologically sound proposal and sign a data-use agreement to ensure confidentiality and compliance with ethical standards. Requests will be evaluated by the study investigators and relevant institutional authorities.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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