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

Ankle Fracture Clinical Trial

Official title:

The Impact of Liposomal Bupivicaine on Post-Operative Pain in Orthopaedic Trauma Surgery: A Double-Blind Prospective Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480621
• Other study ID #: 623477-4
• Status: Completed
• Phase: Phase 3
• First received: June 22, 2015
• Last updated: September 19, 2017
• Start date: December 2014
• Est. completion date: August 31, 2016

Study information

• Verified date: September 2017
• Source: Jamaica Hospital Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: August 31, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients at least 18 years old.

2. Male or Female

3. All racial and ethnic groups

4. Fractures and fracture/dislocations of the ankle

5. Patients who opt for surgical treatment of their fractures.

6. Patients who consent to be randomized.

7. Patients who are willing to follow-up for a minimum of 52 weeks.

Exclusion Criteria:

1. Patients younger than 18 years old

2. Patients who are on chronic opioids

3. Patients who abuse opioids

4. Patients who are unwilling to follow-up for a minimum of 52 weeks

5. Neurologic condition that could interfere with pain sensation

Related Conditions & MeSH terms

• Ankle Fracture
• Ankle Fractures
• Fractures, Bone

Intervention

Drug:
• Liposomal Bupivacaine with Bupivacaine
Pain medications injected locally during surgery around affected ankle.

Locations

Country	Name	City	State
United States	Jamaica Hospital Medical Center	Jamaica	New York

Sponsors (1)

Lead Sponsor	Collaborator
Jamaica Hospital Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

Joshi GP, Cushner FD, Barrington JW, Lombardi AV Jr, Long WJ, Springer BD, Stulberg BN. Techniques for periarticular infiltration with liposomal bupivacaine for the management of pain after hip and knee arthroplasty: a consensus recommendation. J Surg Orthop Adv. 2015 Spring;24(1):27-35. — View Citation

Lonner JH, Scuderi GR, Lieberman JR. Potential utility of liposome bupivacaine in orthopedic surgery. Am J Orthop (Belle Mead NJ). 2015 Mar;44(3):111-7. Review. — View Citation

Owen RT. Bupivacaine liposome injectable suspension: a new approach to postsurgical pain. Drugs Today (Barc). 2013 Aug;49(8):475-82. doi: 10.1358/dot.2013.49.8.2006992. — View Citation

Robbins J, Green CL, Parekh SG. Liposomal bupivacaine in forefoot surgery. Foot Ankle Int. 2015 May;36(5):503-7. doi: 10.1177/1071100714568664. Epub 2015 Jan 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Levels on a Visual Analog Scale ( VAS)	A Visual Analog Scale (VAS) ranging from 0 to 10 in increments of 1 was used to both qualitatively and quantitatively assess the level and severity of pain during the time points ranging from the immediate post-operative period through 72 hours post-operative. Each number on the scale is accompanied by a visual facial expression that indicates the level of pain, discomfort, and distress appropriate to the number on the scale. The more severe the level of pain, the higher the corresponding number and more distressing the accompanying facial expression. A VAS score of 0 indicates no active pain level and is accompanied by a pleasantly smiling face whereas a VAS score of 10 indicates the most severe active pain level and is accompanied by a visibly-distraught face that is frowning, grimacing, and sweating. The combination of facial expressions and numbers is supposed to provide a language-independent, validated means of assessing pain levels.	Immediate post-operative period until 72 hours post-operatively