Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture
Primary Purpose
Tibia Fracture, Femur Fracture, Humerus Fracture
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Narcotics alone
Narcotics and NSAIDS
Sponsored by
About this trial
This is an interventional treatment trial for Tibia Fracture focused on measuring fracture, Tibia, femur, humerus, narcotics, bimodal, analgesia, long-bone, NSAIDS
Eligibility Criteria
Inclusion Criteria: skeletally mature patients over the age of 18 years Fracture of Tibia, femur, or Humerus. Exclusion Criteria: Open fractures grade III Open fractures with suspected compartment syndrome history of prior fracture in particular limb. Concurrent usage of Steroid drugs, and immunosuppressants. Prior or current history of GI bleeding.
Sites / Locations
- Beth Israel Deaconess Medical Center
Outcomes
Primary Outcome Measures
pain score
Amount of narcotics used
time to fracture healing
Secondary Outcome Measures
return to activity
complications
reoperation rate
Full Information
NCT ID
NCT00240396
First Posted
October 14, 2005
Last Updated
March 21, 2017
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00240396
Brief Title
Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture
Official Title
Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Why Stopped
We were not able to enroll patients.
Study Start Date
October 2005 (undefined)
Primary Completion Date
September 24, 2007 (Actual)
Study Completion Date
September 24, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
5. Study Description
Brief Summary
The purpose of this prospective randomized study is to evaluate the risks and benefits of using bimodal analgesia, (i.e. Narcotics and NSAIDS) vs Narcotics alone post long bone fracture.
Detailed Description
This will be a prospective, randomized, control trial looking at the benefit of bimodal analgesia in the treatment of long bone fractures. The traditional pain control regimen following fracture fixation typically involves a course of narcotics on an as-needed basis for pain relief. Recent data has shown that adding NSAIDS to the pain regimen as part of a bimodal approach to pain control, improves the efficacy of pain management and reduces narcotic use. Laboratory research on NSAIDs as it pertains to bone healing, however, has shown in animal models that there may be a positive association between NSAIDS and non-union rates. In other words, NSAIDS may prevent or delay bone healing. These results, however, have not been tested prospectively in humans.
The purpose of this study is to look at the combination of NSAIDS and narcotics post long bone fracture and monitor the effects on narcotic use and healing rates to ultimately and conclusively establish the risk or benefit of NSAIDS after long bone fracture.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibia Fracture, Femur Fracture, Humerus Fracture
Keywords
fracture, Tibia, femur, humerus, narcotics, bimodal, analgesia, long-bone, NSAIDS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Narcotics alone
Intervention Type
Drug
Intervention Name(s)
Narcotics and NSAIDS
Primary Outcome Measure Information:
Title
pain score
Title
Amount of narcotics used
Title
time to fracture healing
Secondary Outcome Measure Information:
Title
return to activity
Title
complications
Title
reoperation rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
skeletally mature patients over the age of 18 years
Fracture of Tibia, femur, or Humerus.
Exclusion Criteria:
Open fractures grade III
Open fractures with suspected compartment syndrome
history of prior fracture in particular limb.
Concurrent usage of Steroid drugs, and immunosuppressants.
Prior or current history of GI bleeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars C Richardson, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
11091128
Citation
Dumont AS, Verma S, Dumont RJ, Hurlbert RJ. Nonsteroidal anti-inflammatory drugs and bone metabolism in spinal fusion surgery: a pharmacological quandary. J Pharmacol Toxicol Methods. 2000 Jan-Feb;43(1):31-9. doi: 10.1016/s1056-8719(00)00077-0.
Results Reference
background
PubMed Identifier
12440488
Citation
Aspenberg P. Avoid cox inhibitors after skeletal surgery! Acta Orthop Scand. 2002 Oct;73(5):489-90. doi: 10.1080/000164702321022730. No abstract available.
Results Reference
background
PubMed Identifier
14763714
Citation
Allami MK, Giannoudis PV. Cox inhibitors and bone healing. Acta Orthop Scand. 2003 Dec;74(6):771-2. doi: 10.1080/00016470310018351. No abstract available.
Results Reference
background
PubMed Identifier
14711953
Citation
Brown KM, Saunders MM, Kirsch T, Donahue HJ, Reid JS. Effect of COX-2-specific inhibition on fracture-healing in the rat femur. J Bone Joint Surg Am. 2004 Jan;86(1):116-23. doi: 10.2106/00004623-200401000-00017.
Results Reference
background
PubMed Identifier
10963160
Citation
Giannoudis PV, MacDonald DA, Matthews SJ, Smith RM, Furlong AJ, De Boer P. Nonunion of the femoral diaphysis. The influence of reaming and non-steroidal anti-inflammatory drugs. J Bone Joint Surg Br. 2000 Jul;82(5):655-8. doi: 10.1302/0301-620x.82b5.9899.
Results Reference
background
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Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture
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