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Neuraxial Pethidine After Lumbar Surgery Trial

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ClinicalTrials.gov Identifier: NCT00163553
Recruitment Status : Unknown
Verified January 2009 by Austin Health.
Recruitment status was:  Recruiting
First Posted : September 14, 2005
Last Update Posted : January 30, 2009
Sponsor:
Information provided by:
Austin Health

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.

Condition or disease Intervention/treatment Phase
Sciatica Drug: Pethidine Drug: Placebo Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Neuraxial Pethidine After Lumbar Surgery Trial
Study Start Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sciatica
U.S. FDA Resources

Arm Intervention/treatment
Experimental: P
Epidural pethidine group
Drug: Pethidine
Placebo Comparator: N
placebo group
Drug: Placebo



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

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


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)

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

ClinicalTrials.gov Identifier: NCT00163553     History of Changes
Other Study ID Numbers: 01833
First Posted: September 14, 2005    Key Record Dates
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