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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00163553




Registration number
NCT00163553
Ethics application status
Date submitted
9/09/2005
Date registered
14/09/2005
Date last updated
30/01/2009

Titles & IDs
Public title
Neuraxial Pethidine After Lumbar Surgery Trial
Scientific title
Neuraxial Pethidine After Lumbar Surgery Trial
Secondary ID [1] 0 0
01833
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sciatica 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: P - Epidural pethidine group

Placebo comparator: N - placebo group
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cumulative 24-hour pethidine consumption
Assessment method [1] 0 0
Timepoint [1] 0 0
24 hours
Secondary outcome [1] 0 0
Patient data:
Assessment method [1] 0 0
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Age
Assessment method [2] 0 0
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Gender
Assessment method [3] 0 0
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Body mass index
Assessment method [4] 0 0
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Current medications
Assessment method [5] 0 0
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Preoperative opioid analgesic use (none, low, high - high dose being > 300 mg codeine or dextropropoxyphene daily or oral morphine or parenteral opioid use)
Assessment method [6] 0 0
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Compensable status (HNC, TAC, WCV or PMI/SUR) 22
Assessment method [7] 0 0
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Surgical data:
Assessment method [8] 0 0
Timepoint [8] 0 0
Secondary outcome [9] 0 0
Anatomical extent of surgery (number of spinal levels)
Assessment method [9] 0 0
Timepoint [9] 0 0
Secondary outcome [10] 0 0
Highest anatomical surgical level
Assessment method [10] 0 0
Timepoint [10] 0 0
Secondary outcome [11] 0 0
Experience level of primary surgeon (trainee or consultant)
Assessment method [11] 0 0
Timepoint [11] 0 0
Secondary outcome [12] 0 0
Anatomical level of epidural tip (identified from postoperative X-Ray when taken as routine care only)
Assessment method [12] 0 0
Timepoint [12] 0 0
Secondary outcome [13] 0 0
Dural tear at the time of surgery (yes/no)
Assessment method [13] 0 0
Timepoint [13] 0 0
Secondary outcome [14] 0 0
Spinal instrumentation (yes/no)
Assessment method [14] 0 0
Timepoint [14] 0 0
Secondary outcome [15] 0 0
Other end-points (all at 1, 4, 24 and 48 hours unless stated):
Assessment method [15] 0 0
Timepoint [15] 0 0
Secondary outcome [16] 0 0
Cumulative pethidine dose
Assessment method [16] 0 0
Timepoint [16] 0 0
Secondary outcome [17] 0 0
Cumulative morphine dose
Assessment method [17] 0 0
Timepoint [17] 0 0
Secondary outcome [18] 0 0
VAS scores for pain at rest and during movement
Assessment method [18] 0 0
Timepoint [18] 0 0
Secondary outcome [19] 0 0
Sedation score (1 - 4) 16
Assessment method [19] 0 0
Timepoint [19] 0 0
Secondary outcome [20] 0 0
VAS scores for nausea, pruritis
Assessment method [20] 0 0
Timepoint [20] 0 0
Secondary outcome [21] 0 0
Other adverse events: agitation, tremor, hallucinations, seizure
Assessment method [21] 0 0
Timepoint [21] 0 0
Secondary outcome [22] 0 0
Patient satisfaction scale for pain control during study (48 hours)
Assessment method [22] 0 0
Timepoint [22] 0 0
48 hours
Secondary outcome [23] 0 0
(very dissatisfied, dissatisfied, neutral, satisfied, very satisfied) 17
Assessment method [23] 0 0
Timepoint [23] 0 0
Secondary outcome [24] 0 0
Plasma pethidine and norpethidine levels (24 hours)
Assessment method [24] 0 0
Timepoint [24] 0 0
24 hours
Secondary outcome [25] 0 0
Physiotherapy assessment of ability to deep breathe & cough (unable, poor, adequate, good)
Assessment method [25] 0 0
Timepoint [25] 0 0
Secondary outcome [26] 0 0
Length of inpatient stay
Assessment method [26] 0 0
Timepoint [26] 0 0

Eligibility
Key inclusion criteria
* Adults undergoing lumbar spinal surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Austin Health
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Dean A Cowie, MBBS, FANZCA
Address 0 0
Austin Health
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dean A Cowie, MBBS, FANZCA
Address 0 0
Country 0 0
Phone 0 0
61-3-9496-3227
Email 0 0
dean.cowie@austin.org.au
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00163553