Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine With Epinephrine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-17
SponsorBoston Children's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
≥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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Bupivacaine liposome injectable suspension
- Bupivacaine Hydrochloride and Epinephrine Injection
Treatment groups
128 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov