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Neuraxial Pethidine After Lumbar Surgery Trial

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. 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
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

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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

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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT00163553

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Contact: Dean A Cowie, MBBS, FANZCA 61-3-9496-3227

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Australia, Victoria
Austin Health Recruiting
Melbourne, Victoria, Australia, 3084
Contact: Dean A Cowie, MBBS, FANZCA    61-3-9496-5000 ext 3227   
Sponsors and Collaborators
Austin Health
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Principal Investigator: Dean A Cowie, MBBS, FANZCA Austin Health
Layout table for additonal information Identifier: NCT00163553    
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
Additional relevant MeSH terms:
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Sciatic Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia