Continuous Epidural With Dexmedetomidine Adjuvant in Gynecologic Laparotomy
CompletedPhase 4NCT07292324
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Effectiveness of Continuous Epidural With Dexmedetomidine Adjuvant Compared to Without Adjuvant in Gynecologic Laparotomy
- Conditions
- Post Operative Pain, Acute
- Chronic Post Surgical Pain
- Gynecologic Disease
- Interventions
- Drug: Dexmedetomidine & Bupivacaine.
- Drug: Bupivacain
- Sponsor
- Udayana University
- Start date
- 2025-08-21
- Primary completion
- 2025-10-15
- Sex
- Female
- Age range
- from 30 Years to 55 Years
- Results posted
- No results posted in this snapshot
- Countries
- Indonesia
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07292324