Effectiveness of Ultrasound guided- Transverse Abdominis Plane Block using Ketamine with Bupivacaine versus Dexamethasone with Bupivacaine for post operative analgesia in patient undergoing Total Laproscopic Hysterectomy- a prospective randomized double blinded study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To measure the duration of post operative analgesia and time required for primary dose of rescue analgesic after surgery.
研究概览
简要总结
This prospective, randomized, double-blind, comparative study will assess the efficacy of ultrasound-guided transverse abdominis plane (TAP) blocks with ketamine or dexamethasone as adjuvants to 0.5% bupivacaine in 60 patients undergoing total laparoscopic hysterectomy. The patients, aged 30–70 years (ASA grade I and II), will be divided into two groups of 30 each:
- Group BD: TAP block with 0.5% bupivacaine + ketamine (0.5 mg/kg), total 20 mL.
- Group BK: TAP block with 0.5% bupivacaine + dexamethasone (8 mg), total 20 mL.
Procedure Overview:
- Patients will be prepared with standard preoperative protocols, including IV access, standard monitors, and administration of premedications (ondansetron, pantoprazole, glycopyrrolate, midazolam, fentanyl, propofol, and vecuronium).
- After intubation, the TAP block will be performed bilaterally under ultrasound guidance by an experienced anesthesiologist.
- Surgery will proceed under general anesthesia with isoflurane, nitrous oxide, oxygen, and intermittent vecuronium. Pain management intraoperatively includes fentanyl boluses and diclofenac.
Postoperative Monitoring:
- Patients will be monitored for pain using VAS scores and tramadol consumption.
- Ondansetron will be given for vomiting, and tramadol for pain (VAS > 4).
- At 24 hours, patients will rate pain relief satisfaction on a 4-point scale.
The study aims to compare pain relief, tramadol consumption, and patient satisfaction between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients of age 30-70yrs Patients under ASA I and ASA II Patient undergoing elective total laproscopic hysterectomy.
排除标准
- •Patient’s refusal to participate in the study Patient taking anticoagulants Have an allergy or contraindication to the drug used Alcohol or drug abuse Have infection near the block site Have clinically significant neurological, cardiovascular, renal or hepatic disease.
- •ASA III-IV patients Having mental disorder which interferes with visual analogue scale (VAS) evaluation were excluded from the study.
结局指标
主要结局
To measure the duration of post operative analgesia and time required for primary dose of rescue analgesic after surgery.
时间窗: Pain scores at 0, 2, 6, 8, 12, 24 hours post surgery.
To compare nad assess pain scores with bupivacaine plus ketamine versus bupivacaine plus dexamethasone post surgery surgery.
时间窗: Pain scores at 0, 2, 6, 8, 12, 24 hours post surgery.
次要结局
- Vital monitoring( heart rate, BP & spO2) during intra operative period.(Patient satisfaction score(excellent, good, fair, poor))
研究者
Sara Zubair
Institute of medical science and sum hospital