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Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture

Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00240396
Enrollment
0
Registered
2005-10-18
Start date
2005-10-31
Completion date
2007-09-24
Last updated
2017-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femur Fracture, Humerus Fracture, Tibia Fracture

Keywords

fracture, Tibia, femur, humerus, narcotics, bimodal, analgesia, long-bone, NSAIDS

Brief 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.

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.

Interventions

DRUGNarcotics alone
DRUGNarcotics and NSAIDS

Sponsors

Beth Israel Deaconess Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
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.

Design outcomes

Primary

MeasureTime frame
pain score
Amount of narcotics used
time to fracture healing

Secondary

MeasureTime frame
return to activity
complications
reoperation rate

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026