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

Boston Children's Hospital

Status: Not yet enrolling

Conditions: Spinal Fusion; Post Operative Pain

Treatments: Drug: Bupivacaine Hydrochloride and Epinephrine Injection; Drug: Bupivacaine liposome injectable suspension

Study type: Interventional

Funder types: Other

Identifiers

NCT06471348

IRB-P00048597

Details and patient eligibility

About

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.

Enrollment: 128 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
• 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: Single Blind

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128 participants in 2 patient groups

Local infiltration with liposomal bupivacaine

Experimental group

Description:

Patients randomized into the liposomal bupivacaine group will receive anesthesia and undergo standard posterior spinal fusion surgery. The local infiltration would occur in a single stage, after instrumentation and correction maneuver is performed, just prior to closure of the deep fascial layer. The dose would be injected via multiple small volume injections into the paraspinal musculature, spaced approximately 1 cm apart.

Treatment:

Drug: Bupivacaine liposome injectable suspension

Local infiltration with 0.25% bupivacaine with epinephrine

Active Comparator group

Description:

Patients randomized into the 0.25% bupivacaine with epinephrine group will receive anesthesia and undergo standard posterior spinal fusion surgery under the same condition as the intervention group with one exception: the local infiltration will be made up of equal volume of 0.25% bupivacaine with epinephrine. The equal volume of 0.25% bupivacaine with epinephrine will be used in the exact same administration technique as the liposomal bupivacaine group, involving multiple small-volume injections to the paraspinal musculature spaced approximately 1 centimeter apart.

Treatment:

Drug: Bupivacaine Hydrochloride and Epinephrine Injection