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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Arm Injuries
Leg Injuries
Wounds and Injuries
Narcotics
Analgesics
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014