Continuous Epidural With Dexmedetomidine Adjuvant in Gynecologic Laparotomy

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.

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