A Randomized, Controlled Trial to Evaluate Opioid Usage Associated With Femoral Continuous Perineural Infusion and Femoral Single Shot Peripheral Nerve Block After a Hamstring Autograft Anterior Cruciate Ligament Repair.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Opioid Pain Medication
研究概览
简要总结
Anterior cruciate ligament repair using hamstring autograft in children is a painful orthopedic procedure. The current practice to provide analgesia for this procedure include femoral continuous perineural infusion and femoral single shot peripheral nerve block, along with perioperative opioids and NSAIDS both IV and orally. Since the use of opioids can be associated with adverse side effects, which include, but are not limited to nausea, vomiting, constipation, pruritus and respiratory depression, comparing the amount of opioid used with either analgesia delivery method is needed.
详细描述
The trial design is a prospective, randomized, open-label controlled, study. It is not possible to blind the treatment since a catheter must be left in place for the continuous infusion group.
Subjects will be randomized to either the femoral shot/continuous peripheral neural infusion FS-CPNI group or femoral shot/sciatic single shot FS-SS group. After induction of general anesthesia, subjects will receive either a single shot or continuous nerve block. The protocol will not dictate the conduct of the general anesthetic.
In the postoperative period, in addition to the standard monitoring in the recovery room, the numerical rating pain scale(NRS) scores of the patient will be recorded. The timing of the first rescue pain medication and total postoperative opioid and other analgesic medication administered during the hospital stay will be recorded. The patients will be followed in the hospital on the day of surgery (DOS) postoperatively until they are discharged home.
After discharge the patients will be contacted by phone and/or email postoperatively on a daily basis for 72 hours to collect information regarding their use of pain medications (timing and dose), quality of analgesia based on the NRS pain scale, and incidence of side effects. If patients need to be admitted to the hospital postoperatively, their opioid use, pain scores and complications will be recorded while in the hospital.
All the patients will be evaluated in the orthopedic clinic at two weeks, six weeks and six months to assess long term functional outcomes, pain scores and any signs of postoperative neurological deficits.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology (ASA) physical status 1 or 2
- •Male or female subjects ages 14 to 18 years old at time of procedure
- •Patients who undergo an ACL repair using the hamstring autograft at The Children's Hospital of Philadelphia
- •Parental/guardian permission (informed consent) and if appropriate, child assent
排除标准
- •Parents/patients refusal to the placement of a femoral and/or sciatic nerve block
- •Contraindications to femoral and/or sciatic nerve block:
- •Neurologic deficits, including motor and/or sensory deficit of the femoral and sciatic nerves.
- •Patients' inability to participate in pain scoring because of developmental delay.
- •Performance of an all-epiphyseal ACL repair.
- •Allergy to any of the medications used in the study.
- •Presence of a coagulopathy
研究组 & 干预措施
Males Single shot peripheral nerve block
a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).
干预措施: bupivacaine (Drug)
Females Single shot peripheral nerve block
a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).
干预措施: bupivacaine (Drug)
Males Continuous peripheral neural infusion
The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.
干预措施: continuous perineural infusion catheter (Device)
Females Continuous peripheral neural infusion
The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.
干预措施: continuous perineural infusion catheter (Device)
结局指标
主要结局
Opioid Pain Medication
时间窗: 72 hours post-operatively
total postoperative opioid pain medication used during the first 72 hours after the procedure
次要结局
- Duration of Analgesia in the Single Injection Nerve Block and the Continuous Peripheral Neural Infusion Group(72 hours post-operatively)