Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery

Boston Children's Hospital

Status: Enrolling

Conditions: Postoperative Pain; Spinal Fusion

Treatments: Procedure: Local infiltration with 0.25% bupivacaine and epinephrine; Procedure: Placebo of equal volume injectable saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04730531

IRB-P00037508

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Treatment Arm

Experimental group

Description:

Local infiltration with 0.25% bupivacaine and epinephrine

Treatment:

Procedure: Local infiltration with 0.25% bupivacaine and epinephrine

Control Arm

Placebo Comparator group

Description:

Placebo of equal volume injectable saline

Treatment:

Procedure: Placebo of equal volume injectable saline