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Neuraxial Pethidine After Lumbar Surgery Trial

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Austin Health.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00163553
First Posted: September 14, 2005
Last Update Posted: January 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Austin Health
  Purpose
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.

Condition Intervention Phase
Sciatica Drug: Pethidine Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Neuraxial Pethidine After Lumbar Surgery Trial

Resource links provided by NLM:


Further study details as provided by Austin Health:

Primary Outcome Measures:
  • Cumulative 24-hour pethidine consumption [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • Patient data:
  • Age
  • Gender
  • Body mass index
  • Current medications
  • Preoperative opioid analgesic use (none, low, high - high dose being > 300 mg codeine or dextropropoxyphene daily or oral morphine or parenteral opioid use)
  • Compensable status (HNC, TAC, WCV or PMI/SUR) 22
  • Surgical data:
  • Anatomical extent of surgery (number of spinal levels)
  • Highest anatomical surgical level
  • Experience level of primary surgeon (trainee or consultant)
  • Anatomical level of epidural tip (identified from postoperative X-Ray when taken as routine care only)
  • Dural tear at the time of surgery (yes/no)
  • Spinal instrumentation (yes/no)
  • Other end-points (all at 1, 4, 24 and 48 hours unless stated):
  • Cumulative pethidine dose
  • Cumulative morphine dose
  • VAS scores for pain at rest and during movement
  • Sedation score (1 - 4) 16
  • VAS scores for nausea, pruritis
  • Other adverse events: agitation, tremor, hallucinations, seizure
  • Patient satisfaction scale for pain control during study (48 hours) [ Time Frame: 48 hours ]
  • (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied) 17
  • Plasma pethidine and norpethidine levels (24 hours) [ Time Frame: 24 hours ]
  • Physiotherapy assessment of ability to deep breathe & cough (unable, poor, adequate, good)
  • Length of inpatient stay

Estimated Enrollment: 60
Study Start Date: December 2004
Arms Assigned Interventions
Experimental: P
Epidural pethidine group
Drug: Pethidine
Placebo Comparator: N
placebo group
Drug: Placebo

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults undergoing lumbar spinal surgery

Exclusion Criteria:

  • 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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163553


Contacts
Contact: Dean A Cowie, MBBS, FANZCA 61-3-9496-3227 dean.cowie@austin.org.au

Locations
Australia, Victoria
Austin Health Recruiting
Melbourne, Victoria, Australia, 3084
Contact: Dean A Cowie, MBBS, FANZCA    61-3-9496-5000 ext 3227    dean.cowie@austin.org.au   
Sponsors and Collaborators
Austin Health
Investigators
Principal Investigator: Dean A Cowie, MBBS, FANZCA Austin Health
  More Information

ClinicalTrials.gov Identifier: NCT00163553     History of Changes
Other Study ID Numbers: 01833
First Submitted: September 9, 2005
First Posted: September 14, 2005
Last Update Posted: January 30, 2009
Last Verified: January 2009

Keywords provided by Austin Health:
spinal surgery
pethidine
analgesia

Additional relevant MeSH terms:
Sciatica
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Meperidine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia