Neuraxial Pethidine After Lumbar Surgery Trial - Full Text View

Sponsor:	Austin Health
Information provided by:	Austin Health
ClinicalTrials.gov Identifier:	NCT00163553

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Neuraxial Pethidine After Lumbar Surgery Trial

Resource links provided by NLM:

MedlinePlus related topics: Sciatica Surgery

Drug Information available for: Meperidine hydrochloride Meperidine

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
P: Experimental Epidural pethidine group	Drug: Pethidine
N: Placebo Comparator placebo group	Drug: Placebo

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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

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

Keywords provided by Austin Health:

spinal surgery
pethidine
analgesia

Additional relevant MeSH terms:

Sciatic Neuropathy
Neuralgia
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Depressants
Narcotics
Pain
Mononeuropathies
Pharmacologic Actions
Meperidine
Adjuvants, Anesthesia

Sciatica
Signs and Symptoms
Neuromuscular Diseases
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Diseases
Neurologic Manifestations
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010