Text Size

Neuraxial Pethidine After Lumbar Surgery Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Austin Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Austin Health
ClinicalTrials.gov Identifier:
NCT00163553
First received: September 9, 2005
Last updated: January 29, 2009
Last verified: January 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Neuraxial Pethidine After Lumbar Surgery Trial

Resource links provided by NLM:

MedlinePlus related topics: Sciatica
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00163553     History of Changes
Other Study ID Numbers: 01833
Study First Received: September 9, 2005
Last Updated: January 29, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Adjuvants, Anesthesia
Narcotics

ClinicalTrials.gov processed this record on May 19, 2013