Efficacy of Peri-Incisional Multimodal Drug Injection Following Operative Management of Femur Fractures
1 other identifier
interventional
102
1 country
1
Brief Summary
The purpose of this study is to determine the efficacy and safety of a peri-incisional multimodal injection for post-operative pain control following operative management of femur fractures. Enrolled subjects will be prospectively randomized into either the peri-incisional injection or control cohorts. Patients will be treated with standard of care surgical techniques by the treating orthopaedic surgeon for the patient's specific fracture pattern. The patients randomized into the injection cohort will receive an intra-operative injection with 400 mg ropivacaine, 0.6 mg epinephrine, 5 mg and morphine into the local superficial and deep peri-incisional tissues while under general anesthesia. Visual analog pain scores will be collected every 4 hours after surgery for the first two post-operative days. Total narcotic consumption will also be recorded over eight hour intervals for the first two post-operative days. Medication related side effects will be monitored. The investigators hypothesize that the peri-incisional injection cohort will demonstrate an improved pain profile and utilize less parenteral narcotic analgesia in the early post-operative period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 31, 2016
CompletedFirst Posted
Study publicly available on registry
June 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
April 5, 2018
CompletedApril 5, 2018
April 1, 2018
1.3 years
May 31, 2016
January 5, 2018
April 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analog Scale Pain Assessment
Patients will describe their current level of comfort on a 10 point scale while at rest. Zero corresponds to "no pain" and ten corresponds to "the most extreme possible pain." Visual analog scores will be collected by nursing staff who are blinded to the treatment allocation.
Pain assessment will be collected immediately prior to surgery (pre-op), immediately following surgery in the post-anesthesia care unit (PACU), and every 4 hours following surgery for the first two post-operative days (48 hours total; 4H-48H)
Secondary Outcomes (1)
Total Narcotic Consumption
Narcotic consumption will be recorded every 8 hours for the first two post-operative days.
Other Outcomes (1)
Number of Participants With Medication-related Side Effects
48 hours following surgery
Study Arms (2)
Peri-incisional injection
EXPERIMENTALA 100 cc multimodal analgesic cocktail will be injected into the superficial and deep peri-incisional tissues after the completion of femur fracture fixation/instrumentation while the patient remains under general anesthesia and prior to wound closure. This cocktail includes 400 mg of 0.75% ropivacaine (53.33 mL), 0.6 mg of 1 mg/mL epinephrine (0.6 mL), 5 mg of 0.5 mg/mL morphine sulfate (10 mL), and 36.07 mL 0.9% sodium chloride solution. All infiltrations will be completed with a blunt trochar to minimize the risk of intravascular injection.
Control (no injection)
NO INTERVENTIONFemur fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.
Interventions
400 mg of 0.75% ropivacaine (53.33 mL) will be included in the multimodal analgesic cocktail that will be injected intra-operatively into the superficial and deep peri-incisional tissues after completion of femur fracture fixation/instrumentation.
0.6 mg of 1 mg/mL epinephrine (0.6 mL) will be included in the multimodal analgesic cocktail that will be injected intra-operatively into the superficial and deep peri-incisional tissues after completion of femur fracture fixation/instrumentation.
5 mg of 0.5 mg/mL morphine sulfate (10 mL) will be included in the multimodal analgesic cocktail that will be injected intra-operatively into the superficial and deep peri-incisional tissues after completion of femur fracture fixation/instrumentation.
36.07 mL 0.9% sodium chloride solution will be included in the multimodal analgesic cocktail that will be injected intra-operatively into the superficial and deep peri-incisional tissues after completion of femur fracture fixation/instrumentation.
Eligibility Criteria
You may qualify if:
- Patients who sustained an acute femur fracture in any anatomic region (subcapital, basicervical, intertrochanteric, subtrochanteric, diaphyseal, distal metaphyseal, or distal articular)
- Age ≥18 years
- Indicated for definitive operative management at a single Level 1 trauma center
You may not qualify if:
- Revision procedures
- Temporizing procedures (irrigation and debridement, external fixation)
- Regular narcotic use
- Psychiatric illness
- Dementia
- Neuromuscular deficit
- Allergy/intolerance to cocktail ingredients
- Clinical status that precludes verbal pain assessment (e.g. major intracranial trauma)
- Refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Related Publications (4)
Vendittoli PA, Makinen P, Drolet P, Lavigne M, Fallaha M, Guertin MC, Varin F. A multimodal analgesia protocol for total knee arthroplasty. A randomized, controlled study. J Bone Joint Surg Am. 2006 Feb;88(2):282-9. doi: 10.2106/JBJS.E.00173.
PMID: 16452738BACKGROUNDBusch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. doi: 10.2106/JBJS.E.00344.
PMID: 16651569BACKGROUNDBusch CA, Whitehouse MR, Shore BJ, MacDonald SJ, McCalden RW, Bourne RB. The efficacy of periarticular multimodal drug infiltration in total hip arthroplasty. Clin Orthop Relat Res. 2010 Aug;468(8):2152-9. doi: 10.1007/s11999-009-1198-7. Epub 2009 Dec 18.
PMID: 20020333BACKGROUNDKang H, Ha YC, Kim JY, Woo YC, Lee JS, Jang EC. Effectiveness of multimodal pain management after bipolar hemiarthroplasty for hip fracture: a randomized, controlled study. J Bone Joint Surg Am. 2013 Feb 20;95(4):291-6. doi: 10.2106/JBJS.K.01708.
PMID: 23302898BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Michael Willey
- Organization
- University of Iowa Hospitals and Clinics
Study Officials
- PRINCIPAL INVESTIGATOR
Michael C Willey, MD
University of Iowa
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
May 31, 2016
First Posted
June 8, 2016
Study Start
May 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
April 5, 2018
Results First Posted
April 5, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share