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
This trial does not accept healthy volunteersQualifiers
≥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
Design model
Parallel
Treatments tested in this trial
Bupivacaine liposome injectable suspension
DrugEXPAREL 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.
Bupivacaine Hydrochloride and Epinephrine Injection
DrugSensorcaine-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).
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Local infiltration with liposomal bupivacaineExperimental treatment 1 intervention
Group B: Local infiltration with 0.25% bupivacaine with epinephrineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total amount of morphine equivalents per kilogram
Total amount of morphine equivalents per kilogram during the first 72 hours postoperatively.
Time frame
72 hours postoperativelySecondary outcomes
1
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 postoperatively2
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 postoperativelySponsors and contacts
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Source ClinicalTrials.gov