Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Total amount of morphine equivalents per kilogram
研究概览
简要总结
A randomized controlled trial (RCT) investigating whether the local anesthetic injection of liposomal bupivacaine during posterior spinal fusion (PSF) for AIS is more effective in reducing acute postoperative opioid consumption compared to an equal volume injection of 0.25% bupivacaine with epinephrine for patients aged 10 to 17, with 128 patients randomly assigned to one of two arms: liposomal bupivacaine or 0.25% bupivacaine with epinephrine.
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 (Participant)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥10 years old and ≤17 years old at assessment
- •Diagnosis of Adolescent Idiopathic Scoliosis
- •Planned surgical treatment of progressive spinal deformity with posterior spinal fusion
排除标准
- •Diagnosis of neuromuscular, syndromic, or congenital scoliosis
- •History of known allergy to local anesthesia
- •Chronic pre-operative opioid consumptions
- •Any other analgesic treatment for chronic pain before surgery
- •Psychiatric or neurological disorders
- •Cannot fluently read or speak English
研究组 & 干预措施
Local infiltration with liposomal bupivacaine
Patients randomized into the liposomal bupivacaine group will receive anesthesia and undergo standard posterior spinal fusion surgery. The local infiltration would occur in a single stage, after instrumentation and correction maneuver is performed, just prior to closure of the deep fascial layer. The dose would be injected via multiple small volume injections into the paraspinal musculature, spaced approximately 1 cm apart.
干预措施: Bupivacaine liposome injectable suspension (Drug)
Local infiltration with 0.25% bupivacaine with epinephrine
Patients randomized into the 0.25% bupivacaine with epinephrine group will receive anesthesia and undergo standard posterior spinal fusion surgery under the same condition as the intervention group with one exception: the local infiltration will be made up of equal volume of 0.25% bupivacaine with epinephrine. The equal volume of 0.25% bupivacaine with epinephrine will be used in the exact same administration technique as the liposomal bupivacaine group, involving multiple small-volume injections to the paraspinal musculature spaced approximately 1 centimeter apart.
干预措施: Bupivacaine Hydrochloride and Epinephrine Injection (Drug)
结局指标
主要结局
Total amount of morphine equivalents per kilogram
时间窗: 72 hours postoperatively
Total amount of morphine equivalents per kilogram during the first 72 hours postoperatively.
次要结局
- Pain, functional ability, and mental health scores(1-, 6-, 12-, and 24-months postoperatively)
- Numeric Rating Scale (NRS) pain scores(72 hours postoperatively)
研究者
Craig Birch
Instructor of Orthopedic Surgery, Harvard Medical School
Boston Children's Hospital