Study Summary
This trial is testing a new pain medication for people with broken ankles.
Eligible Conditions
- Ankle Fracture
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 72 postoperative hours
72 postoperative hours
Oral Narcotics / Morphine Milligram Equivalents (MME) given
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
3 Treatment Groups
Traditional Pain Control Care
1 of 3
Regional Anesthesia
1 of 3
Long-Acting Local Anesthesia
1 of 3
Active Control
Experimental Treatment
70 Total Participants · 3 Treatment Groups
Primary Treatment: Long-Acting Local Anesthesia · No Placebo Group · Phase 4
Regional Anesthesia
Drug
Experimental Group · 1 Intervention: Regional Anesthesia · Intervention Types: DrugLong-Acting Local Anesthesia
Drug
Experimental Group · 1 Intervention: Long-Acting Local Anesthesia · Intervention Types: DrugTraditional Pain Control CareNoIntervention Group · 1 Intervention: Traditional Pain Control Care · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regional Anesthesia
2007
Completed Phase 4
~3530
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 72 postoperative hours
Who is running the clinical trial?
University of Massachusetts, WorcesterLead Sponsor
312 Previous Clinical Trials
753,789 Total Patients Enrolled
Lahey ClinicLead Sponsor
70 Previous Clinical Trials
244,968 Total Patients Enrolled
Paul Matuszewski, MDPrincipal InvestigatorUniversity of Kentucky
1 Previous Clinical Trials
55 Total Patients Enrolled
Eric Swart, MDPrincipal Investigator - Lahey Hospital & Medical Center
UMass Memorial Medical Center-Memorial Campus, UMass Memorial Medical Center-University Campus
Harvard Medical School (Residency)
1 Previous Clinical Trials
55 Total Patients Enrolled
Eligibility Criteria
Age 18 - 89 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:We will include patients with syndesmotic injuries because it is hard to confirm the injury before the surgery.
You have a certain type of ankle fracture that does not require surgery on the back part of the ankle.
You have a single injury without any other medical conditions.
References
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- Barrington, John W., Oluseun Olugbode, Scott Lovald, Kevin Ong, Heather Watson, and Roger H. Emerson Jr.. 2015. “Liposomal Bupivacaine”. Orthopedic Clinics of North America. Elsevier BV. doi:10.1016/j.ocl.2015.06.003.
- Lonner, Jess. 2014. “Role of Liposomal Bupivacaine in Pain Management After Total Joint Arthroplasty”. Journal of Surgical Orthopaedic Advances. Data Trace Publishing Company. doi:10.3113/jsoa.2014.0037.
- Cometa, M. Anthony, Andrea T. Esch, and André P. Boezaart. 2011. “Did Continuous Femoral and Sciatic Nerve Block Obscure the Diagnosis or Delay the Treatment of Acute Lower Leg Compartment Syndrome? A Case Report”. Pain Medicine. Oxford University Press (OUP). doi:10.1111/j.1526-4637.2011.01109.x.
- Bramlett, Kenneth, Erol Onel, Eugene R. Viscusi, and Kevin Jones. 2012. “A Randomized, Double-blind, Dose-ranging Study Comparing Wound Infiltration of Depofoam Bupivacaine, an Extended-release Liposomal Bupivacaine, to Bupivacaine Hcl for Postsurgical Analgesia in Total Knee Arthroplasty”. The Knee. Elsevier BV. doi:10.1016/j.knee.2011.12.004.
- Ng, Fu-Yuen, Jacobus Kwok-Fu Ng, Kwong-Yuen Chiu, Chun-Hoi Yan, and Chi-Wing Chan. 2012. “Multimodal Periarticular Injection Vs Continuous Femoral Nerve Block After Total Knee Arthroplasty”. The Journal of Arthroplasty. Elsevier BV. doi:10.1016/j.arth.2011.12.021.
- Mulligan, Ryan P., Joel G. Morash, James K. DeOrio, and Selene G. Parekh. 2017. “Liposomal Bupivacaine Versus Continuous Popliteal Sciatic Nerve Block in Total Ankle Arthroplasty”. Foot & Ankle International. SAGE Publications. doi:10.1177/1071100717722366.
- Mar, G.J., M.J. Barrington, and B.R. McGuirk. 2009. “Acute Compartment Syndrome of the Lower Limb and the Effect of Postoperative Analgesia on Diagnosis”. British Journal of Anaesthesia. Elsevier BV. doi:10.1093/bja/aen330.
- Gastevski, Dragan. 2014. “Infiltration of Liposome Bupivacaine into the Transversus Abdominis Plane for Postsurgical Pain Management in a 39-year-old Female Undergoing Laparoscopic Cholecystectomy”. Pain Medicine. Oxford University Press (OUP). doi:10.1111/pme.12356.
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- Eric Francis Swart 2020. "Randomized Controlled Trial for Ankle Fracture Pain Control". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03696199.
Frequently Asked Questions
Would I be a good candidate for this clinical research?
"This trial is looking for 70 patients, aged 18 to 89, who have ankle fractures that meet the following criteria: Isolated Injury, Sustained a bimalleolar ankle fracture (OTA/AO type 44 A2, B2, C1, and C2 fracture) with surgery indicated and an approach with medial and lateral incisions planned. Syndesmotic injuries will be included due to the practical difficulty of reliably determining the presence of a syndesmotic injury preoperatively. Trimalleolar ankle fractures where fixation of the posterior malleolus is not planned will also be included." - Anonymous Online Contributor
Unverified Answer
What is the governmental organization's opinion on Long-Acting Local Anesthesia?
"Long-Acting Local Anesthesia received a score of 3 because Phase 4 trials are conducted after the treatment has been approved." - Anonymous Online Contributor
Unverified Answer
Are there opportunities for patients to enroll in this trial?
"Yes, the latest information from clinicaltrials.gov suggests that this trial is still open for recruitment. The study was first posted on January 1st 2020 and was last updated on August 18th 2022. They are looking to enroll a total of 70 patients across 3 sites." - Anonymous Online Contributor
Unverified Answer
Does this research allow people who are over 45 years old to participate?
"This study includes all patients aged 18-89, as specified in the eligibility requirements." - Anonymous Online Contributor
Unverified Answer