NCT00241332

Brief Summary

The aim of this trial is to examine the possibility that fentanyl 1,5 µgr/kg given intravenously (i.v.) before the start of remifentanil infusion for anesthesia gives less development of tolerance/hyperalgesia postoperative than fentanyl given at the end of surgery (the traditional method).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_3

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

July 6, 2011

Status Verified

September 1, 2005

First QC Date

October 17, 2005

Last Update Submit

July 3, 2011

Conditions

Pain, Postoperative

Keywords

painhyperalgesiadrug toleranceremifentanilfentanylAnterior Cruciate LigamentPosterior Cruciate LigamentMedial Collateral Ligament, Knee

Outcome Measures

Primary Outcomes (2)

  • Less use of postoperative opioids

  • Less visual analog scale (VAS) and verbal rating scale (VRS) in the treatment group

Interventions

fentanylDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women and men \> 18 years.
  • Informed consent.
  • Elective day-orthopedic surgery: damage to anterior cruciate ligament and/or posterior cruciate ligament with or without medial collateral ligament.

You may not qualify if:

  • Patients who use nonsteroidal anti-inflammatory drugs (NSAID's) or are allergic to NSAID's.
  • Patients using steroids, anti-emetics, drugs or opioids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ullevaal University Hospital

Oslo, Oslo County, 0407, Norway

Location

MeSH Terms

Conditions

Pain, PostoperativePainHyperalgesia

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsSomatosensory DisordersSensation DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Johan Ræder, Prof.MD,Phd

    Ullevaal University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 17, 2005

First Posted

October 18, 2005

Study Start

October 1, 2005

Study Completion

July 1, 2006

Last Updated

July 6, 2011

Record last verified: 2005-09

Locations

NO(1)