Analgesic Effect of Fentanyl Vs Dexmedetomidine As Adjuvant to Bupivacaine in Combined IPACK and Adductor Canal Block After Knee Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- ● The total amount of rescue analgesic consumption (tramadol)
研究概览
简要总结
This study will be undertaken to compare the analgesic effects of of fentanyl versus dexmedetomidine as adjuvant to bupivacaine in combined IPACK and ACB for pain management after total knee arthroplasty.
详细描述
- To measure the total amount of rescue analgesic consumption in the first 48 hours post-operatively in each group
- To assess pain score in each group by using Numerical Rating Scale (NRS) at rest (static) and during flexion or extension of knee (dynamic) at different time points: PACU, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs and 48 hrs.
- To measure the time of first request of rescue analgesia in each group
- To record the incidence of adverse events (hematoma, local anesthetic toxicity, infection, nausea and vomiting) and length of hospital stay.
- Over all patients' satisfaction: The patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points Likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia).
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, Outcomes Assessor)
盲法说明
anesthetist not sharing in the study will assess patients
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1 - Patient acceptance
- •Cooperative patients
- •Age: ≥21 and 85< years' old
- •Sex: both sexes (males or females).
- •Physical status: ASA Ι & II& Ш.
- •Body Mass Index (BMI): ≤ 35 kg/m
- •Type of operation: elective unilateral knee surgeries (TKA, ACL, knee arthroscopy)
排除标准
- •. Patient with any contraindications of regional blocks (as coagulopathy or local infection at injection site)
- •Patients with known history of allergy to the study drugs (bupivacaine, dexmedetomidine and fentanyl).
- •Advanced hepatic, renal, cardiovascular, neurologic and respiratory diseases.
- •4.Chronic opioid use (more than 3 months or daily oral morphine > 5 mg /day for 1 month)
研究组 & 干预措施
Control group (group C)
The patient receive unilateral ultrasound guided combined IPACK and ACB with bupivacaine only. two syringes , one for each block , each one contains (20 mL of 0.25% bupivacaine and 1 ml saline)
干预措施: Control group (Procedure)
Dexmedetomidine group (group D)
The patient receive unilateral ultrasound guided combined IPACK and ACB with bupivacaine only. two syringes , one for each block , each one contains (20 mL of 0.25% bupivacaine and 1 ug/kg dexmedetomidine not exceeding 100 ug (to be completed to 1mL with normal saline if needed). )
干预措施: Dexmedetomidine group (Procedure)
Fentanyl group (group F)
The patient receive unilateral ultrasound guided combined IPACK and ACB with bupivacaine only. two syringes , one for each block , each one contains (20 mL of 0.25% bupivacaine and 50 mcg fentanyl)
干预措施: Fentanyl group (Procedure)
结局指标
主要结局
● The total amount of rescue analgesic consumption (tramadol)
时间窗: For 48 hrs
● The total amount of rescue analgesic consumption (tramadol) postoperatively in each group
Pain intensity by using Numerical Rating Scale (NRS) at rest (static) and during flexion or extension of knee (dynamic) at different time points
时间窗: 0 hours (basal) ( on arrival to PACU), 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs and 48 hrs
NRS is 10 cm line numbered from 0 to 10, patients instructed to circle the number that represents his/her pain intensity (0=no pain and 10=maximum pain)
次要结局
- The time to first request of rescue analgesia (tramadol)(24 hours postoperative)
- The length of hospital stays(For 48-72 hrs)
- The incidence of adverse events(For 48 hrs)
- patient's satisfaction(For 48 hrs)
研究者
Dina Abdelhameed Elsadek Salem
principle investigator
Zagazig University