Effectiveness of Continuous Epidural With Dexmedetomidine Adjuvant Compared to Without Adjuvant in Gynecologic Laparotomy
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 30-55 years
- •ASA physical status I-III
- •Body Mass Index (BMI) 18 - 29.9 kg/m2
- •Patients undergoing gynecologic laparotomy
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Dexmedetomidine & Bupivacaine. (Drug)
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.
干预措施: Bupivacain (Drug)
结局指标
主要结局
Postoperative Pain Intensity (VAS)
时间窗: 6, 12, and 24 hours post-operation
Pain intensity is assessed using the Visual Analogue Scale (VAS). The VAS consists of a 100 mm straight line where the left end indicates "no pain" and the right end indicates "very severe pain" (0-100 mm). Participants mark the line to indicate their pain level. Higher scores indicate worse pain
次要结局
- Total Bupivacaine Consumption(24 hours post-operation.)
- Total PCEA Demands(24 hours post-operation.)
- Change in Nuclear Factor Kappa B (NFκB) Level(Baseline (Pre-operative) and 24 hours post-operation.)
- Incidence of Chronic Postsurgical Pain(3 months post-operation.)
- Incidence of Bradycardia(Up to 24 hours post-operation.)
研究者
Simson Samuel Soerodjotanojo
Anesthesiology Resident
Udayana University