Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture

Femur Fracture Clinical Trial

Official title:

Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00240396
• Other study ID #: 2005P000205
• Status: Withdrawn
• Phase: N/A
• First received: October 14, 2005
• Last updated: March 21, 2017
• Start date: October 2005
• Est. completion date: September 24, 2007

Study information

• Verified date: March 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 24, 2007
• Est. primary completion date: September 24, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Fractures, Bone
• Humeral Fractures
• Humerus Fracture
• Tibia Fracture
• Tibial Fractures

Intervention

Drug:
• Narcotics alone

• Narcotics and NSAIDS

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

Allami MK, Giannoudis PV. Cox inhibitors and bone healing. Acta Orthop Scand. 2003 Dec;74(6):771-2. — View Citation

Aspenberg P. Avoid cox inhibitors after skeletal surgery! Acta Orthop Scand. 2002 Oct;73(5):489-90. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score
Primary	Amount of narcotics used
Primary	time to fracture healing
Secondary	return to activity
Secondary	complications
Secondary	reoperation rate