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Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Beth Israel Deaconess Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00240396
First received: October 14, 2005
Last updated: November 16, 2005
Last verified: November 2005
History of Changes
  Purpose

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.


Condition Intervention
Tibia Fracture
Femur Fracture
Humerus Fracture
 Drug: Narcotics alone
Drug: Narcotics and NSAIDS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • pain score
  • Amount of narcotics used
  • time to fracture healing

Secondary Outcome Measures:
  • return to activity
  • complications
  • reoperation rate

Estimated Enrollment: 150
Study Start Date: October 2005
Estimated Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00240396

Contacts
Contact: Lars C Richardson, MD 617-232-2663 lrichard@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jule Frechette     617-667-3940     jfrechet@bidmc.harvard.edu    
Contact: Stacy Lewis     6176673940     selewis@bidmc.harvard.edu    
Sub-Investigator: Edward K Rodriguez, MD, PhD            
Sub-Investigator: Miguel A Ramirez, BS            
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Lars C Richardson, MD Beth Israel Deaconess Medical Center
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00240396     History of Changes
Other Study ID Numbers: 2005p000205
Study First Received: October 14, 2005
Last Updated: November 16, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
fracture
Tibia
femur
humerus
narcotics
 bimodal
analgesia
long-bone
NSAIDS

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Humeral Fractures
Tibial Fractures
Wounds and Injuries
Leg Injuries
Arm Injuries
Anti-Inflammatory Agents, Non-Steroidal
Narcotics
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Depressants
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013