Comparing the Effect of Three Different Volumes of Bupivacaine in Infiltration Between Popliteal Artery and Capsule of Knee Block Following Adductor Canal Block in Total Knee Arthroplasty, Prospective Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- visual analogue score ( VAS) for 24 hours postoperatively
研究概览
简要总结
comparing between three different volumes; 15, 20 & 25 ml of 0.25% bupivacaine to determine the best volume of Infiltration Between Popliteal Artery and Capsule of Knee (IPACK) block following adductor canal block (ACB) with the best analgesia and least complications after total knee arthroplasty (TKA)
详细描述
105 participants will be randomized into three groups based on computer generated numbers using online randomization program
Preoperative assessment is conducted on the patients that will be enrolled in this study including history taking, physical examination, and routine laboratory investigations; in the form of CBC, coagulation profile, creatinine, urea, ALT, AST and radiological investigations; according to the medical condition of the patients. All patients should fulfill the inclusion criteria.
a written informed consent form will be obtained from the patients that will be enrolled in the study.
Preoperative:
On the day of surgery, the patient ID will be confirmed in the preparation room, then 18 G cannula will be inserted to the patient, premedication will be given including lactated ringer solution 500 ml, midazolam 2 mg & metoclopramide 10 mg.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing knee arthroscopy surgery.
- •Age between 18 years and 65 years.
- •Both sexes
- •ASA I & ASA II
排除标准
- •Patients' refusal
- •Allergy to any drug that will be used in the study
- •Psychological or mental disorders.
- •Disturbance of Conscious level.
- •Uncooperative patients
- •Coagulopathy
- •Contraindications to spinal anaesthesia (e.g.: severe mitral stenosis)
研究组 & 干预措施
group A
The patients in this group will be administered 15 ml bupivacaine 0.250 % between the popliteal artery and the capsule of the posterior knee.
干预措施: Bupivacaine 0.25% Preservative-Free Injectable Solution (Drug)
Group B
The patients in this group will be administered 20 ml bupivacaine 0.250 % between the popliteal artery and the capsule of the posterior knee.
干预措施: Bupivacaine 0.25% Preservative-Free Injectable Solution (Drug)
Group C
The patients in this group will be administered 25 ml bupivacaine 0.250 % between the popliteal artery and the capsule of the posterior knee.
干预措施: Bupivacaine 0.25% Preservative-Free Injectable Solution (Drug)
结局指标
主要结局
visual analogue score ( VAS) for 24 hours postoperatively
时间窗: 24 hours
assessment of pain score
次要结局
- morphine consumption(24 hours)
- morphine complications(24 hours)
- postoperative hemodynamics(24 hours)
- first rescue analgesia time(24 hours)
- sensory block(24 hours)
研究者
Heba Omar Ahmed
Associate professor of Anesthesia, pain management & surgical ICU
Cairo University