Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine With Epinephrine

Boston Children's Hospital128 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

128

Conditions

Post Operative Pain Spinal Fusion

Interventions

Bupivacaine Hydrochloride and Epinephrine InjectionDRUG

Sensorcaine-MPF with Epinephrine 1:200,000 is a clear, colorless to slightly yellow solution available as single-dose vials. Each mL contains bupivacaine hydrochloride, 0.005 mg epinephrine, and 0.5 mg sodium metabisulfite (antioxidant), and 0.2 mg anhydrous citric acid (stabilizer).

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ≥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 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

Total amount of morphine equivalents per kilogram

Total amount of morphine equivalents per kilogram during the first 72 hours postoperatively.

Time frame: 72 hours postoperatively

Secondary Outcomes

Numeric Rating Scale (NRS) pain scores

The average Numeric Rating Scale pain score (on a scale of 0-10) during the first 72 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.

Time frame: 72 hours postoperatively

Pain, functional ability, and mental health scores

SRS-22r scores at 1-, 6-, 12-, and 24-months post-operatively. The Scoliosis Patient Questionnaire Version 22r (SRS-22r) is a patient-reported outcome instrument with 22 questions that evaluates the impact of scoliosis and surgery on patient quality of life. Scores from the SRS-22r are compiled into five domain scores: function, pain, 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.

Time frame: 1-, 6-, 12-, and 24-months postoperatively