NCT00240396

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2007

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

October 14, 2005

Last Update Submit

March 21, 2017

Conditions

Tibia FractureFemur FractureHumerus Fracture

Keywords

fractureTibiafemurhumerusnarcoticsbimodalanalgesialong-boneNSAIDS

Outcome Measures

Primary Outcomes (3)

  • pain score

  • Amount of narcotics used

  • time to fracture healing

Secondary Outcomes (3)

  • return to activity

  • complications

  • reoperation rate

Interventions

Narcotics aloneDRUG
Narcotics and NSAIDSDRUG

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • skeletally mature patients over the age of 18 years
  • Fracture of Tibia, femur, or Humerus.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (5)

  • 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. doi: 10.1016/s1056-8719(00)00077-0.

    PMID: 11091128BACKGROUND

  • Aspenberg P. Avoid cox inhibitors after skeletal surgery! Acta Orthop Scand. 2002 Oct;73(5):489-90. doi: 10.1080/000164702321022730. No abstract available.

    PMID: 12440488BACKGROUND

  • Allami MK, Giannoudis PV. Cox inhibitors and bone healing. Acta Orthop Scand. 2003 Dec;74(6):771-2. doi: 10.1080/00016470310018351. No abstract available.

    PMID: 14763714BACKGROUND

  • 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(1):116-23. doi: 10.2106/00004623-200401000-00017.

    PMID: 14711953BACKGROUND

  • 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. doi: 10.1302/0301-620x.82b5.9899.

    PMID: 10963160BACKGROUND

MeSH Terms

Conditions

Tibial FracturesFemoral FracturesHumeral FracturesFractures, BoneAgnosia

Interventions

NarcoticsAnti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Wounds and InjuriesLeg InjuriesArm InjuriesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Central Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic UsesAnalgesics, Non-NarcoticAnti-Inflammatory AgentsAntirheumatic Agents

Study Officials

  • Lars C Richardson, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor in Orthopedic Surgery, Part-time

Study Record Dates

First Submitted

October 14, 2005

First Posted

October 18, 2005

Study Start

October 1, 2005

Primary Completion

September 24, 2007

Study Completion

September 24, 2007

Last Updated

March 22, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)