Ultrasound Guided Nerve Block Combinations for Anterior Cruciate Ligament Reconstruction; Femoral, Saphenous and Obturator (Posterior Branch)Nerves.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- NRS (pain score)
研究概览
简要总结
Anterior cruciate ligament reconstruction is a routine surgical procedure. Traditional femoral/sciatic block combinations effectively reduce postoperative pain, but results in considerable motor blockade. The investigators aimed to evaluate postoperative pain relief and the degree of motor block with block combinations of femoral nerve (FEM) and obturator [posterior branch] nerve (ONP), versus saphenous nerve (SAPH) and ONP, versus placebo blocks with isotonic saline. All patients received standard patient controlled analgesia with morphine.Randomized, placebo-controlled and double-blinded clinical trial. Following IRB approval, 81 patients were planned to be randomized to one of three USG block combinations: Active FEM+ONP, active SAPH+ONP or no active blocks (sham blocks) Ropivacaine 0.75% was used for all active blocks following induction of general anaesthesia [propofol-remifentanil, laryngeal mask airway]. Primary outcome measure: Localized PACU pain scores (AUC) 0-6 hours postoperatively at rest.
Secondary outcome measures: Opioid consumption, opioid related side effects, PACU time, motor abilities of daily living scores [modified Barthel/100 index], perceived ill health [Short form-8] scores and degree of motor blockade [Jensen- Børglum motor test].
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)
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
- •Age ≥ 18 years.
- •Isolated primary ACL reconstruction in general anaesthesia with hamstring graft.
- •Written and informed consent to study protocol.
排除标准
- •ACL reconstruction with patellar tendon graft
- •Uncooperative patients.
- •Patients that do not understand or speak danish.
- •Daily use of opioids equivalent to > 40 mg morphine.
- •Allergic to Ropivacaine.
- •Alcohol abusers
- •Contraindications to general anaesthesia.
- •Pregnancy.
研究组 & 干预措施
Active FEM+ONP
Nerveblock of n. femoralis (FEM) with 10 ml Ropivacaine 7.5 mg/ml and nerveblock of obturator nerveposterior branch (ONP) with 10 ml Ropivacaine 7.5 mg/ml.
干预措施: Ropivacaine (Drug)
Active SAPH+ONP
Nerveblock of n.saphenous (SAPH) with 5 ml Ropivacaine 7.5 mg/ml and nerveblock of obturator nerve, posterior branch (ONP) with 10 ml Ropivacaine 7.5 mg/ml
干预措施: Ropivacaine (Drug)
Placebo
Saline 9 mg/ml
干预措施: placebo (Drug)
结局指标
主要结局
NRS (pain score)
时间窗: Area under the curve (AUC) 0-6 hours postoperatively
Numerical rating scale(0-10)
次要结局
- Opioid consumption(0-6 hours postoperatively)
- opioid related side effects(0-6 hours postoperatively)
- Motor abilities of of daily living(0-24 hours postoperatively)
- PACU time(0-6 hours postoperatively)
- Perceived ill health(0-24 hours postoperatively)
- Degree of motor block.(0-6 hours postoperatively)
研究者
Jens Borglum Neimann
Associate professor
Bispebjerg Hospital