NCT00163553

Brief Summary

The hypothesis is that epidural pethidine is an effective form of pain relief following lumbar spinal surgery, resulting in significantly lower usage of concomitantly administered (intravenous) patient-controlled analgesia (PCA) pethidine.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

January 30, 2009

Status Verified

January 1, 2009

First QC Date

September 9, 2005

Last Update Submit

January 29, 2009

Conditions

Sciatica

Keywords

spinal surgerypethidineanalgesia

Outcome Measures

Primary Outcomes (1)

  • Cumulative 24-hour pethidine consumption

    24 hours

Secondary Outcomes (26)

  • Patient data:

  • Age

  • Gender

  • Body mass index

  • Current medications

  • +21 more secondary outcomes

Study Arms (2)

P

EXPERIMENTAL

Epidural pethidine group

Drug: Pethidine

N

PLACEBO COMPARATOR

placebo group

Drug: Placebo

Interventions

PethidineDRUG
P
PlaceboDRUG
N

Eligibility Criteria

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

You may qualify if:

  • Adults undergoing lumbar spinal surgery

You may not qualify if:

  • Lack of informed patient consent
  • Acute or chronic renal failure
  • Known allergy or intolerance to pethidine or tramadol
  • Chronic respiratory insufficiency
  • Epidural contraindicated (coagulopathy, systemic infection)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Austin Health

Melbourne, Victoria, 3084, Australia

RECRUITING

MeSH Terms

Conditions

SciaticaAgnosia

Interventions

Meperidine

Condition Hierarchy (Ancestors)

Sciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Isonipecotic AcidsAcids, HeterocyclicHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Dean A Cowie, MBBS, FANZCA

    Austin Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dean A Cowie, MBBS, FANZCA

CONTACT

61-3-9496-3227dean.cowie@austin.org.au

Study Design

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

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

December 1, 2004

Last Updated

January 30, 2009

Record last verified: 2009-01

Locations

AU(1)