NCT Number: NCT06471348
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.
Interested in participating?
Request Info10 year–17 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
Location status: Recruiting
Craig Birch, MD
PRINCIPAL_INVESTIGATOR
Daniel Hedequist, MD
SUB_INVESTIGATOR
Grant Hogue, MD
SUB_INVESTIGATOR
Sara Olenich, MS
CONTACT
Timothy Hresko, MD
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
EXPAREL is a milky white too off-white aqueous suspension available as single-dose vials. Each mL contains 13.3 mg of bupivacaine, which is contained in multivesicular liposomes.
Other names: EXPAREL
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).
Other names: Sensorcaine-MPF with Epinephrine 1:200,000
Time frame: 72 hours postoperatively
Total amount of morphine equivalents per kilogram during the first 72 hours postoperatively.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Mikayla Flowers, MA
CONTACT
Sara Olenich, MS
CONTACT
Boston Children's Hospital
Other
Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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