Continuous Epidural With Dexmedetomidine Adjuvant in Gynecologic Laparotomy

March 24, 2026 updated by: Simson Samuel Soerodjotanojo, Udayana University

Effectiveness of Continuous Epidural With Dexmedetomidine Adjuvant Compared to Without Adjuvant in Gynecologic Laparotomy

The goal of this clinical trial is to learn if adding a medication called dexmedetomidine to an epidural block works better than a standard epidural to control pain in women undergoing gynecologic laparotomy (abdominal surgery). The main questions it aims to answer are:

Does adding dexmedetomidine reduce pain scores and the need for extra pain medicine in the first 24 hours after surgery? Does it lower inflammation levels and reduce the risk of developing chronic pain 3 months later?

Participants will receive an epidural (pain medicine delivered through a small tube in the back) combined with general anesthesia for their surgery. Researchers will compare two groups:

One group will receive the standard epidural medicine (bupivacaine) mixed with dexmedetomidine.

The other group will receive the standard epidural medicine (bupivacaine) alone.

Researchers will measure the participants' pain levels, how much pain medicine they use, and blood markers for inflammation for 24 hours after surgery. They will also contact participants 3 months later to check for any long-term pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a double-blind, randomized, pre- and post-test control group study to evaluate the effectiveness of adding dexmedetomidine as an adjuvant to continuous epidural analgesia for patients undergoing gynecologic laparotomy.

Postoperative pain following laparotomy can be severe and is associated with inflammation and a risk of developing chronic postsurgical pain (CPSP). While epidural analgesia is a standard method for pain management, this study investigates whether the addition of dexmedetomidine (an alpha-2 adrenergic agonist) provides superior analgesia and anti-inflammatory effects compared to local anesthetic alone.

Participants aged 30-55 with ASA physical status I-III will be randomized into two groups:

Group P1 (Intervention): Receives an epidural bolus and continuous infusion of bupivacaine 0.1% combined with dexmedetomidine 0.5 mcg/ml.

Group P2 (Control): Receives an epidural bolus and continuous infusion of bupivacaine 0.1% alone.

The epidural catheter will be inserted at the L1-L2 level prior to the induction of general anesthesia. Postoperative pain will be managed using a Patient-Controlled Epidural Analgesia (PCEA) pump with specific settings (3 ml/hr background infusion, 5 ml bolus demand, 30-minute lockout).

Key outcome measures include:

Acute Pain: Visual Analogue Scale (VAS) scores recorded at 6, 12, and 24 hours post-operation.

Analgesic Consumption: Total volume of bupivacaine used and total PCEA demands in 24 hours.

Inflammatory Response: Changes in Nuclear Factor Kappa B (NFκB) levels measured from blood samples taken pre-operatively and 24 hours post-operatively.

Chronic Pain: Incidence of chronic pain assessed 3 months post-operatively using the Brief Pain Inventory Short Form (BPI-SF).

Safety: Monitoring for adverse events such as hypotension and bradycardia.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Indonesia
    • Bali
      • Denpasar, Bali, Indonesia, 80114
        • Prof. Dr. I.G.N.G Ngoerah Central General Hospital

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 30-55 years
  • ASA physical status I-III
  • Body Mass Index (BMI) 18 - 29.9 kg/m2
  • Patients undergoing gynecologic laparotomy

Exclusion Criteria:

  • Contraindications for regional anesthesia
  • Allergy or contraindication to dexmedetomidine
  • Routine use of antidepressants or anticonvulsants
  • Chronic opioid consumption (equivalent to >30 mg oral morphine per day for >1 month)
  • History of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
  • Active systemic autoimmune disease or receiving immunosuppressant therapy (e.g., Systemic Lupus Erythematosus, Rheumatoid Arthritis, Multiple Sclerosis)
  • Inability to use the Visual Analogue Scale (VAS) or operate the Patient-Controlled Epidural Analgesia (PCEA) device
  • Coagulation disorders (prolonged hemostasis)
  • Refusal to participate

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group P1 (Dexmedetomidine Adjuvant)
Participants receive epidural analgesia with Bupivacaine 0.1% combined with Dexmedetomidine 0.5 mcg/ml. This is administered as a 10 ml loading dose before incision, followed by a continuous infusion (PCEA) at a rate of 3 ml/hour, with a demand dose of 5 ml and a lockout interval of 30 minutes for 24 hours post-operation.
Drug: Dexmedetomidine & Bupivacaine.
Epidural administration of Bupivacaine 0.1% combined with Dexmedetomidine 0.5 mcg/ml. Subjects receive a loading dose of 10 ml before incision. This is followed by a continuous infusion using Patient-Controlled Epidural Analgesia (PCEA) with a background rate of 3 ml/hour, a demand dose of 5 ml, and a lockout interval of 30 minutes for 24 hours post-operation.
Active Comparator: Group P2 (Control)
Participants receive epidural analgesia with Bupivacaine 0.1% alone (without adjuvant). This is administered as a 10 ml loading dose before incision, followed by a continuous infusion (PCEA) at a rate of 3 ml/hour, with a demand dose of 5 ml and a lockout interval of 30 minutes for 24 hours post-operation.
Drug: Bupivacain
Epidural administration of Bupivacaine 0.1% without adjuvant. Subjects receive a loading dose of 10 ml before incision. This is followed by a continuous infusion using Patient-Controlled Epidural Analgesia (PCEA) with a background rate of 3 ml/hour, a demand dose of 5 ml, and a lockout interval of 30 minutes for 24 hours post-operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Intensity (VAS)
Time Frame: 6, 12, and 24 hours post-operation
Pain intensity is assessed using the Visual Analogue Scale (VAS). The VAS consists of a 100 mm straight line where the left end indicates "no pain" and the right end indicates "very severe pain" (0-100 mm). Participants mark the line to indicate their pain level. Higher scores indicate worse pain
6, 12, and 24 hours post-operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Bupivacaine Consumption
Time Frame: 24 hours post-operation.
The total volume of Bupivacaine (in milliliters) consumed via the Patient-Controlled Epidural Analgesia (PCEA) pump during the postoperative period.
24 hours post-operation.
Total PCEA Demands
Time Frame: 24 hours post-operation.
The total number of times the participant pressed the PCEA button to request an analgesic bolus dose (total demand).
24 hours post-operation.
Change in Nuclear Factor Kappa B (NFκB) Level
Time Frame: Baseline (Pre-operative) and 24 hours post-operation.
The difference in serum levels of the inflammatory biomarker Nuclear Factor Kappa B (NFκB). This is calculated as the value at 24 hours post-operation minus the pre-operative baseline value.
Baseline (Pre-operative) and 24 hours post-operation.
Incidence of Chronic Postsurgical Pain
Time Frame: 3 months post-operation.
The occurrence of chronic pain assessed using the Brief Pain Inventory Short Form (BPI-SF). The BPI-SF measures pain severity (worst, least, average, now) and pain interference with daily activities. Scores range from 0 to 10, with higher scores indicating worse pain/interference .
3 months post-operation.
Incidence of Bradycardia
Time Frame: Up to 24 hours post-operation.
The number of participants experiencing bradycardia, defined as a heart rate less than 50 beats per minute
Up to 24 hours post-operation.

Collaborators and Investigators

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

Sponsor

Udayana University

Investigators

  • Principal Investigator: Simson Samuel Soerodjotanojo, Udayana University
  • Study Director: I Gusti Ngurah Mahaalit Aribawa, Udayana University
  • Study Director: I Made Agus Kresna Sucandra, Udayana University

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)

August 21, 2025

Primary Completion (Actual)

October 15, 2025

Study Completion (Actual)

January 15, 2026

Study Registration Dates

First Submitted

December 5, 2025

First Submitted That Met QC Criteria

December 5, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2171102008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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