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Clinical Trials/NCT04730531
NCT04730531
Recruiting
N/A

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

Boston Children's Hospital1 site in 1 country100 target enrollmentJune 2, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Boston Children's Hospital
Enrollment
100
Locations
1
Primary Endpoint
Visual Analog Scale (VAS) pain score
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2, 2022
End Date
December 1, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Craig Birch

Instructor of Orthopedic Surgery, Harvard Medical School

Boston Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • ≥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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Visual Analog Scale (VAS) pain score

Time Frame: 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 Outcomes

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

Study Sites (1)

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