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Continuous Epidural With Dexmedetomidine Adjuvant in Gynecologic Laparotomy

NCT07292324 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-03-25

No results posted yet for this study

Summary

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.

Conditions

  • Post Operative Pain, Acute
  • Chronic Post Surgical Pain
  • Gynecologic Disease

Interventions

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.

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.

Sponsors & Collaborators

  • Udayana University

    lead OTHER

Principal Investigators

  • Simson Samuel Soerodjotanojo · Udayana University

  • I Gusti Ngurah Mahaalit Aribawa · Udayana University

  • I Made Agus Kresna Sucandra · Udayana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-21
Primary Completion
2025-10-15
Completion
2026-01-15

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07292324 on ClinicalTrials.gov