Continuous Epidural With Dexmedetomidine Adjuvant in Gynecologic Laparotomy

NCT ID: NCT07292324

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-21
• Study Completion Date: 2026-01-15

Brief 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

Keywords

Dexmedetomidine; Bupivacaine; Epidural Analgesia; Gynecologic Laparotomy; NF-kappa B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dexmedetomidine & Bupivacaine.

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Bupivacain

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Udayana University

OTHER

Sponsor Role: lead

Responsible Party

Simson Samuel Soerodjotanojo

Anesthesiology Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simson Samuel Soerodjotanojo

Role: PRINCIPAL_INVESTIGATOR

Udayana University

I Gusti Ngurah Mahaalit Aribawa

Role: STUDY_DIRECTOR

Udayana University

I Made Agus Kresna Sucandra

Role: STUDY_DIRECTOR

Udayana University

Locations

Prof. Dr. I.G.N.G Ngoerah Central General Hospital

Denpasar, Bali, Indonesia

Countries

Indonesia

References

Gao Y, Chen Z, Huang Y, Sun S, Yang D. Comparison of dexmedetomidine and opioids as local anesthetic adjuvants in patient controlled epidural analgesia: a meta-analysis. Korean J Anesthesiol. 2024 Feb;77(1):139-155. doi: 10.4097/kja.22730. Epub 2023 May 2.

Reference Type: BACKGROUND

PMID: 37127531 (View on PubMed)

Zhang X, Wang D, Shi M, Luo Y. Efficacy and Safety of Dexmedetomidine as an Adjuvant in Epidural Analgesia and Anesthesia: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Clin Drug Investig. 2017 Apr;37(4):343-354. doi: 10.1007/s40261-016-0477-9.

Reference Type: BACKGROUND

PMID: 27812971 (View on PubMed)

Hetta DF, Fares KM, Abedalmohsen AM, Abdel-Wahab AH, Elfadl GMA, Ali WN. Epidural dexmedetomidine infusion for perioperative analgesia in patients undergoing abdominal cancer surgery: randomized trial. J Pain Res. 2018 Oct 30;11:2675-2685. doi: 10.2147/JPR.S163975. eCollection 2018.

Reference Type: BACKGROUND

PMID: 30464585 (View on PubMed)

Other Identifiers

2171102008

Identifier Type: -

Identifier Source: org_study_id