Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture - Full Text View

Sponsored by:	Beth Israel Deaconess Medical Center
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00240396

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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

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. Review.

Aspenberg P. Avoid cox inhibitors after skeletal surgery! Acta Orthop Scand. 2002 Oct;73(5):489-90. No abstract available.

Allami MK, Giannoudis PV. Cox inhibitors and bone healing. Acta Orthop Scand. 2003 Dec;74(6):771-2. No abstract available.

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-A(1):116-23.

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.

Study ID Numbers:	2005p000205
Study First Received:	October 14, 2005
Last Updated:	November 16, 2005
ClinicalTrials.gov Identifier:	NCT00240396 History of Changes
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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Fractures, Bone
Wounds and Injuries
Central Nervous System Depressants
Disorders of Environmental Origin
Pain
Humeral Fractures
Narcotics
Tibial Fractures

Arm Injuries
Femoral Fractures
Analgesics, Non-Narcotic
Leg Injuries
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Physiological Effects of Drugs
Fractures, Bone
Wounds and Injuries
Central Nervous System Depressants
Disorders of Environmental Origin
Humeral Fractures
Narcotics
Tibial Fractures
Pharmacologic Actions
Arm Injuries

Femoral Fractures
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Leg Injuries
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009