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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This study has been withdrawn prior to enrollment.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.)
Information provided by (Responsible Party):
Lars Richardson, Beth Israel Deaconess Medical Center Identifier:
First received: October 14, 2005
Last updated: March 21, 2017
Last verified: March 2017
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: No masking
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

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.


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00240396

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

Responsible Party: Lars Richardson, Instructor in Orthopedic Surgery, Part-time, Beth Israel Deaconess Medical Center Identifier: NCT00240396     History of Changes
Other Study ID Numbers: 2005P000205
Study First Received: October 14, 2005
Last Updated: March 21, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Beth Israel Deaconess Medical Center:

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Humeral Fractures
Femoral Fractures
Wounds and Injuries
Leg Injuries
Arm Injuries
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on May 25, 2017