Subsartorial Saphenous Nerve Block (SSNB) Versus Femoral Nerve Block (FNB) in Primary Total Knee Arthroplasty (TKA) Combined With Infiltration Between Popliteal Artery and Capsule of the Knee (IPACK) - Where Are the Benefits?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Functional muscle power output of the leg
研究概览
简要总结
The goal of this clinical trial is to compare two different types of nerve blocks in patients undergoing surgery for primary Total Knee Arthroplasty. The main question aim to answer is:
- is there a benefit in functional muscle power output of the leg?
Participants will be randomized into either the intervention group or the control group and:
- receive Subsartorial Saphenous Nerve Block (SSNB) + IPACK in intervention group (group 1)
- receive Femoral Nerve Block (FNB) + IPACK in control group (group 2)
Researchers will compare the 2 groups to see if there are differences in :
- functional muscle power output of the leg?
- muscle function, mobility, clinical and radiological results, ROM, pain control (NRS), opioid consumption, length of hospital stay, patient satisfaction, mobility, reduction of costs?
详细描述
Prospective, randomized, double-blinded, single-center, controlled clinical trial with intervention group (SSNB + IPACK, group 1) and control group (FNB + IPACK, group 2), randomization by sealed envelopes.
The number of participants will be 72 per group, calculated based on a sample size calculator program.
The 3 surgeons will be blinded as well as the patients regarding the nerve block they will receive.
We will explain to the patients how both the blocks will be carried out, that 1 block will be located "higher on the leg" and 1 "lower on the leg". The nerve blocks will be carried out by a well-trained anaesthesiologist following standard procedures preoperative.
The IPACK will be applied by the surgeons intraoperative, following a standard protocol. The used implant for all patients will be the cemented ATTUNE™ Primary Knee System® (DePuySynthes Johnson&Johnson).
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)
盲法说明
randomization by sealed envelopes
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intervention group: SSNB + IPACK (group 1)
Subsartorial Nerve Block:
- 15ml bupivacaine 0.5% + clonidine 1mcg/kg for prolongation of the block effect
- anatomic landmarks: proximal adductor channel, intersection of the medial borders of the sartorius muscle and the adductor longus, guided by ultrasound control
- no patch to puncture site to not jeopardise the surgeon's blinding
- IPACK: 15ml bupivacaine 0.5% after completion of the femoral preparation
干预措施: SSNB + IPACK (Other)
Control group: FNB + IPACK (group 2)
Femoral Nerve Block:
- 15ml bupivacaine 0.5% + clonidine 1mcg/kg for prolongation of the block effect
- anatomic landmarks: lateral to the femoral artery,level of the femoral crease (proximal to the vascular outlet of the deep artery of the thigh), femoral nerve lies on the surface of the iliopsoas muscle and is covered by the fascia iliaca, guided by ultrasound control
- no patch to puncture site to not jeopardise the surgeon's blinding
- IPACK: 15ml bupivacaine 0.5% after completion of the femoral preparation
干预措施: FNB + IPACK (Other)
结局指标
主要结局
Functional muscle power output of the leg
时间窗: preoperative, 6 weeks, 12 weeks, 1 year after surgery
Cycle sprint test measuring maximum lower limb muscle power in Watts (W) from 3 times 10-second maximal efforts (higher values better)
次要结局
- Muscle strength(preoperative, 48 hours after surgery, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery)
- Radiological results(preoperative(1-3), day 1 after surgery(1), 6 weeks(1-2), 1 year after surgery(1-3))
- Opioid consumption(before surgery, during hospital stay, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery)
- Length of hospital stay(before surgery, during hospital stay, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery)
- Clinical results(preoperative, day of discharge (7+/- 2 days postoperative), 6, 12 weeks, 1 year after surgery)
- Pain control(before surgery, twice daily on the ward (except first 6 hours: hourly), day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery)
- Mobility(preoperative, 48 hours after surgery, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks1 year after surgery)
- Patient satisfaction 1(preoperative, 6 weeks, 12 weeks, 1 year after surgery)
- Patient satisfaction 2(preoperative, 6 weeks, 12 weeks, 1 year after surgery)
研究者
Judith Bering
Principal Investigator
Luzerner Kantonsspital