NCT00254631

Brief Summary

We would like to check whether pre-operative administration of an oral controlled-release opioid formulation (Oxycodone hydrochloride (OxyContin)) could result in a clear effect of preemptive analgesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2005

Completed
1.4 years until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

1.7 years

First QC Date

November 15, 2005

Last Update Submit

February 4, 2015

Conditions

Fractures

Keywords

long bone fractureopen fracturesclosed fracturestrauma

Outcome Measures

Primary Outcomes (1)

  • post operative pain scores during first 24 hours (Visual analog scale)

    24 hours after surgery

Secondary Outcomes (4)

  • Time to first analgesic request

    at PACU

  • Total other pain medications at first 24 hours post operative

    first 24 hours after surgery

  • Time to first oral intake

    first 24 hours after surgery

  • Length of hospitalization

    after surgery

Study Arms (2)

study group

ACTIVE COMPARATOR

pre operative medication with 20 mg oxycontine PO

Drug: Oxycodone hydrochloride

placebo group

PLACEBO COMPARATOR

pre operative medication with placebo tablet PO

Interventions

Oxycodone hydrochlorideDRUG
study group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient consent.
  • Age 18 years to 60 years.
  • Isolated limb bone fracture/s.

You may not qualify if:

  • Patient refusal.
  • Age 61 years and older.
  • Known allergy to study medication.
  • Multiple bone fractures in different limbs.
  • Multiple trauma.
  • Oncological patients.
  • Respiratory depression / respiratory insufficiency / hypercarbia.
  • Acute bronchial asthma.
  • CNS depression / hallucinations.
  • Alzheimer / dementia.
  • Known convulsive disorder.
  • Prostate hypertrophy.
  • Paralytic ileus.
  • Renal dysfunction (plasma creatinine \> 1.5).
  • Liver dysfunction.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RAMBAM Health Care Campus

Haifa, 31096, Israel

Location

Related Publications (5)

  • Bach S, Noreng MF, Tjellden NU. Phantom limb pain in amputees during the first 12 months following limb amputation, after preoperative lumbar epidural blockade. Pain. 1988 Jun;33(3):297-301. doi: 10.1016/0304-3959(88)90288-6.

    PMID: 3419837BACKGROUND

  • Code WE, Yip RW, Rooney ME, Browne PM, Hertz T. Preoperative naproxen sodium reduces postoperative pain following arthroscopic knee surgery. Can J Anaesth. 1994 Feb;41(2):98-101. doi: 10.1007/BF03009799.

    PMID: 8131242BACKGROUND

  • Woolf CJ, Chong MS. Preemptive analgesia--treating postoperative pain by preventing the establishment of central sensitization. Anesth Analg. 1993 Aug;77(2):362-79. doi: 10.1213/00000539-199377020-00026. No abstract available.

    PMID: 8346839BACKGROUND

  • Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.

    PMID: 10422923BACKGROUND

  • Ong CK, Lirk P, Seymour RA, Jenkins BJ. The efficacy of preemptive analgesia for acute postoperative pain management: a meta-analysis. Anesth Analg. 2005 Mar;100(3):757-773. doi: 10.1213/01.ANE.0000144428.98767.0E.

    PMID: 15728066BACKGROUND

MeSH Terms

Conditions

Fractures, BoneFractures, OpenFractures, ClosedWounds and Injuries

Interventions

Oxycodone

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Ruth Edery, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rambam Health Care Campus

Study Record Dates

First Submitted

November 15, 2005

First Posted

November 16, 2005

Study Start

April 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

February 5, 2015

Record last verified: 2015-02

Locations

IL(1)