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

Not Applicable

Not yet recruiting

• Conditions: Spinal Fusion; Post Operative Pain
• Interventions: Drug: Bupivacaine liposome injectable suspension; Drug: Bupivacaine Hydrochloride and Epinephrine Injection

• Registration Number: NCT06471348
• Lead Sponsor: Boston Children's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-21
• Status Verified: 2024-06
• Study Start: 2024-06-15
• Study First Submitted QC: 2024-06-18
• Last Update Submitted: 2024-06-18
• Study First Posted: 2024-06-24
• Last Update Posted: 2024-06-24
• Primary Completion: 2026-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 128

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local infiltration with liposomal bupivacaine	Bupivacaine liposome injectable suspension	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.
Local infiltration with 0.25% bupivacaine with epinephrine	Bupivacaine Hydrochloride and Epinephrine Injection	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain, functional ability, and mental health scores	1-, 6-, 12-, and 24-months postoperatively	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.
Numeric Rating Scale (NRS) pain scores	72 hours postoperatively	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.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States