Continuous Epidural With Dexmedetomidine Adjuvant in Gynecologic Laparotomy

Udayana University

Status and phase: Active, not recruiting; Phase 4

Conditions: Gynecologic Disease; Chronic Post Surgical Pain; Post Operative Pain, Acute

Treatments: Drug: Bupivacain; Drug: Dexmedetomidine & Bupivacaine.

Study type: Interventional

Funder types: Other

Identifiers

NCT07292324

2171102008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: Female

Ages: 30 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 2 patient groups

Group P1 (Dexmedetomidine Adjuvant)

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine & Bupivacaine.

Group P2 (Control)

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacain