NCT07292324

Continuous Epidural With Dexmedetomidine Adjuvant in Gynecologic Laparotomy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Udayana University · Academic / Other
• Sex: Female
• Age: 30 Years – 55 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-21
• Primary completion: 2025-10-15
• Completion: 2026-01-15
• First posted: 2025-12-18
• Last updated: 2026-03-25

Locations

1 site across 1 country: Indonesia