Liposomal Bupivacaine With Bupivacaine in Ankle Fracture Open Reduction Internal Fixation (ORIF)

J

Jamaica Hospital Medical Center

Status and phase

Completed
Phase 3

Conditions

Ankle Fracture

Treatments

Drug: Liposomal Bupivacaine with Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02480621
623477-4

Details and patient eligibility

About

This study is a randomized controlled trial assessing pain control in ankle fractures repaired with open reduction and internal fixation. Patients are consented and enrolled pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine administered intra-operatively.

Full description

This study is a prospective, randomized controlled trial assessing pain control in ankle fractures repaired with open reduction and internal fixation. Patients are consented and enrolled pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine administered intra-operatively. Patients are to remain blinded to the treatment arm. The surgeon is non-blinded and administers the bupivacaine solution locally, intra-operatively. Patients pain scores and pain medication usage is documented. A trained research coordinator contacts each patient at 24, 48, and 72 hours post-operatively to assess pain levels on a visual analog scale (VAS) and pain medications taken. Patients return for followup at standard intervals of 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post-operatively to assess healing and functional outcomes. Patients are queried as to satisfaction with pain control at 2 weeks post-operatively. The study will compare outcomes including pain levels, pain medications taken, operating room (OR) and post-anesthesia care unit (PACU) times, length of stay (LOS), satisfaction with pain control, clinical outcomes, and complication rates.

Enrollment

84 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients at least 18 years old.
  • Male or Female
  • All racial and ethnic groups
  • Fractures and fracture/dislocations of the ankle
  • Patients who opt for surgical treatment of their fractures.
  • Patients who consent to be randomized.
  • Patients who are willing to follow-up for a minimum of 52 weeks.

Exclusion criteria

  • Patients younger than 18 years old
  • Patients who are on chronic opioids
  • Patients who abuse opioids
  • Patients who are unwilling to follow-up for a minimum of 52 weeks
  • Neurologic condition that could interfere with pain sensation

Trial design

84 participants in 2 patient groups

Control
No Intervention group
Description:
Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle.
Liposomal Bupivacaine with Bupivacaine
Experimental group
Description:
Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle.
Treatment:
Drug: Liposomal Bupivacaine with Bupivacaine

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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