Pain, Postoperative Clinical Trial
Official title:
Efficacy of Peri-Incisional Multimodal Drug Injection Following Operative Management of Femur Fractures: A Randomized Controlled Trial
Verified date | April 2018 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 102 |
Est. completion date | August 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
University of Iowa |
United States,
Busch 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. — View Citation
Busch 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. — View Citation
Kang 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants With Medication-related Side Effects | Patients will be monitored every 15 minutes in the recovery room and every 4 hours for the first two post-operative days by nursing personnel for medication side effects related to ropivacaine toxicity including blurred vision, hearing problems, transient peripheral paralysis, dizziness, convulsion, uncontrolled muscle contraction, hypotension, bradycardia, and new onset arrhythmia. | 48 hours following surgery | |
Primary | 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 | Total Narcotic Consumption | Parenteral and oral narcotic agents will be utilized by patients for post-operative pain control per the standard of care. No alterations in narcotic prescription behavior will be observed for this study. | Narcotic consumption will be recorded every 8 hours for the first two post-operative days. |
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