Liposomal Bupivacaine vs. Bupivacaine with Epinephrine for Postoperative Pain
Trial Summary
Do I need to stop taking my current medications for this trial?
The trial does not specify if you need to stop taking your current medications, but it excludes those who are on chronic pain treatments or opioids before surgery.
What data supports the effectiveness of the drug Liposomal Bupivacaine for postoperative pain?
Research shows that liposomal bupivacaine, which is a form of bupivacaine that lasts longer in the body, can help reduce pain after surgery and decrease the need for other pain medications like opioids. It has been found to be effective in various surgical settings, including burn patients, and may lead to shorter hospital stays and increased patient satisfaction.12345
Is liposomal bupivacaine safe for use in humans?
What makes liposomal bupivacaine unique for postoperative pain management?
What is the purpose of 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.
Research Team
Craig Birch, MD
Principal Investigator
Boston Children's Hospital
Eligibility Criteria
This trial is for young patients aged 10 to 17 who are undergoing posterior spinal fusion surgery for Adolescent Idiopathic Scoliosis (AIS). It's designed to see if a new pain control method works better after surgery. Patients with certain health conditions or on medications that could interfere with the study may not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo posterior spinal fusion surgery with local infiltration of either liposomal bupivacaine or 0.25% bupivacaine with epinephrine
Postoperative Monitoring
Participants' opioid consumption and pain scores are monitored for 72 hours postoperatively
Follow-up
Participants are monitored for pain, functional ability, and mental health scores at 1-, 6-, 12-, and 24-months postoperatively
Treatment Details
Interventions
- Bupivacaine Hydrochloride and Epinephrine Injection
- Bupivacaine liposome injectable suspension
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Children's Hospital
Lead Sponsor