USG Nerve Blocks for ACL Reconstruction
Ultrasound Guided Nerve Block Combinations for Anterior Cruciate Ligament Reconstruction; Femoral, Saphenous and Obturator (Posterior Branch)Nerves.
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].
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Copenhagen、丹麦、2400
- Bispebjerg Hospital, department of anesthesiology
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age ≥ 18 years.
- Isolated primary ACL reconstruction in general anaesthesia with hamstring graft.
- ASA 1-3.
- Written and informed consent to study protocol.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器: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.
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有源比较器: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
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安慰剂比较:Placebo
Saline 9 mg/ml
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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NRS (pain score)
大体时间:Area under the curve (AUC) 0-6 hours postoperatively
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Numerical rating scale(0-10)
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Area under the curve (AUC) 0-6 hours postoperatively
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Opioid consumption
大体时间:0-6 hours postoperatively
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Opioid consumption (PCA pump - mg of morphine)
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0-6 hours postoperatively
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opioid related side effects
大体时间:0-6 hours postoperatively
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Nausea (0-3), vomiting (>10 ml)
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0-6 hours postoperatively
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PACU time
大体时间:0-6 hours postoperatively
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Minutes in PACU
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0-6 hours postoperatively
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Motor abilities of of daily living
大体时间:0-24 hours postoperatively
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Modified Barthel/100 index
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0-24 hours postoperatively
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Perceived ill health
大体时间:0-24 hours postoperatively
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Short-Form-8
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0-24 hours postoperatively
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Degree of motor block.
大体时间:0-6 hours postoperatively
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Jensen-Borglum motor test
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0-6 hours postoperatively
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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