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Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture

This study has been withdrawn prior to enrollment.
(We were not able to enroll patients.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00240396
First Posted: October 18, 2005
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lars Richardson, Beth Israel Deaconess Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (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 Lars Richardson, 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

Enrollment: 0
Study Start Date: October 2005
Study Completion Date: September 24, 2007
Primary Completion Date: September 24, 2007 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240396


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Lars C Richardson, MD Beth Israel Deaconess Medical Center
  More Information

Publications:
Responsible Party: Lars Richardson, Instructor in Orthopedic Surgery, Part-time, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00240396     History of Changes
Other Study ID Numbers: 2005P000205
First Submitted: October 14, 2005
First Posted: October 18, 2005
Last Update Posted: March 23, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Humeral Fractures
Tibial Fractures
Wounds and Injuries
Leg Injuries
Arm Injuries
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents


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