Transversus Abdominis Plane Block : A Comparative Study Between Bupivacaine vs Bupivacaine With Ketamine in Total Abdominal Hystrectomy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- VAS score
研究概览
简要总结
The goal of this study is to know how effectively TAP block can reduce postoperative pain in total abdominal hystrectomy patients when given ketamine in addition to bupivacaine in TAP block and to compare it with the conventional TAP block with bupivacaine only. The main question it aims to answer is:
Does intervention with ketamine in TAP block lowers the postoperative pain measured via visual analog scale and decreases the need for rescue analgesia?
Patients will be assessed for pain in PACU( post anesthesia care unit), 6 hours, 12 hours and 24 hours postoperatively. Time of rescue analgesia will also be noted if given.
详细描述
This is a prospective, randomized, double blind control trial.Patients will be randomly divided into 2 groups; group A and group B with 15 patients in each group. Group A will recive TAP block with 20ml solution of 0.25% bupivacaine on each side of abdomen while group B will recieve 50mg ketamine in addtion to 20ml of 0.25% bupivacaine.The drugs will be prepared by the second anesthesiologist who will not be part of data collection and analysis.Post operative pain will be assessed using VAS score in PACU, after 6 , 12 and 24hours post total abdominal hystrectomy. Inj. tramadol 50mg will be used as rescue analgesia.In addition to inj. pracetamol 1g 8 hourly and inj. ketorolac 30mg 12 hourly, time for administration of rescue analgesia will be noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged between 25 to 60 years.
- •ASA grade I & II.
- •Undergoing total abdominal hysterectomy.
排除标准
- •BMI >35kg/m
- •Patient refusal for participation.
- •Patients with coagulation disorders.
- •Patents with history of allergy and hypersensitivity to local anesthetic.
- •Patient having infection at the injection site.
- •Alcohol or drug abuse.
- •Cognitive or mental disorder.
研究组 & 干预措施
TAP block with bupivacaine only
干预措施: bupivicaine 0.25% (Drug)
TAP block with bupivacaine plus ketamine
干预措施: bupivicaine 0.25% + ketamine (Drug)
结局指标
主要结局
VAS score
时间窗: At PACU(5 mins after shifting to PACU), 6,12 and 24 hours post-operatively
VAS (visual analog scale ) score noted VAS of \<2 = no pain VAS of 2-4 = mild pain VAS of 5-6 = moderate pain VAS of \>6 = severe pain
Time of receiving first rescue analgesia
时间窗: within first 24 hours postoperatively
time for additional requirment of inj. tramadol 50mg for post operative pain relief
次要结局
未报告次要终点
研究者
Usra Rahim
Principal Investigator
Liaquat National Hospital & Medical College