Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery
- Conditions
- Postoperative PainSpinal Fusion
- Interventions
- Procedure: Local infiltration with 0.25% bupivacaine and epinephrineProcedure: Placebo of equal volume injectable saline
- Registration Number
- NCT04730531
- Lead Sponsor
- Boston Children's Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- ≥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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Arm Local infiltration with 0.25% bupivacaine and epinephrine Local infiltration with 0.25% bupivacaine and epinephrine Control Arm Placebo of equal volume injectable saline Placebo of equal volume injectable saline
- Primary Outcome Measures
Name Time Method Visual Analog Scale (VAS) pain score 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.
- Secondary Outcome Measures
Name Time Method Average use of morphine equivalents 24 hours post-operatively The average use of morphine equivalents per kilogram during the first 24 hours postoperatively. Morphine equivalents per kilogram will be also be obtained by reviewing post-anesthesia care unit reports.
Scoliosis Patient Questionnaire - Version 30 (SRS-30) 1-, 6-, and 12-months post-operatively SRS-30 scores at 1-, 6-, and 12-months post-operatively. The Scoliosis Research Society (SRS-30) questionnaire is a 30-question patient reported instrument developed to evaluate health-related quality of life in patients with scoliosis. Scores from the SRS-30 are compiled into five domain scores: pain, function, self-image, mental health and satisfaction with management of scoliosis. Each domain score is reported on a scale form 1-5. The lower the score, the worse the outcome.
Trial Locations
- Locations (1)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States