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临床试验/NCT04730531
NCT04730531招募中不适用

Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery: A Randomized Control Trial

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年6月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Visual Analog Scale (VAS) pain score

研究概览

简要总结

Non-opioid methods of pain management following posterior spinal fusion (PSF) have become increasingly popular given the rise of opioid abuse and opioid-related deaths. Orthopedic surgery remains one of the highest prescribing subspecialties. Local wound infiltration is an effective method of acute pain management following surgical intervention and is the standard in some surgical subspecialties, however, no randomized control trials (RCT) exist in the pediatric spine literature. This would be the first (RCT) to assess the use of local would infiltration in postoperative pain control following PSF for adolescent idiopathic scoliosis patients (AIS). The primary aim of this study is to investigate the efficacy of local wound infiltration with anesthetic agents in reduction of postoperative pain scores and post-operative opioid use during hospital admission following fusion surgery in AIS patients. The proposed single-center, double-blind prospective randomized study will be conducted by recruiting patients meeting the inclusion criteria of age 10-26 years and diagnosis of AIS undergoing posterior fusion surgery. Study participants will be randomized into either a local injection of 0.25% bupivacaine with epinephrine or a placebo of equal volume injectable saline. Patient-reported outcomes will be collected at 1-, 6-, 12- and 24-months postoperatively.

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
10 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ≥10 years old and ≤17 years old at assessment
  • Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
  • 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

结局指标

主要结局

Visual Analog Scale (VAS) pain score

时间窗: 24 hours post-operatively

The average Visual Analog Scale pain score (on a scale of 0-100 mm) during the first 24 hours postoperatively will be computed from at most six values typically obtained every four to six hours following surgery. The higher the score, the higher the experienced pain of the individual.

次要结局

  • Average use of morphine equivalents(24 hours post-operatively)
  • Scoliosis Patient Questionnaire - Version 30 (SRS-30)(1-, 6-, and 12-months post-operatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Craig Birch

Instructor of Orthopedic Surgery, Harvard Medical School

Boston Children's Hospital

研究点 (2)

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