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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Treatment: Drugs - Pethidine
Treatment: Drugs - Placebo

Experimental: P - Epidural pethidine group

Placebo Comparator: N - placebo group


Treatment: Drugs: Pethidine


Treatment: Drugs: Placebo


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cumulative 24-hour pethidine consumption
Timepoint [1] 0 0
24 hours
Secondary outcome [1] 0 0
Patient data:
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Age
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Gender
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Body mass index
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Current medications
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)
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Compensable status (HNC, TAC, WCV or PMI/SUR) 22
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Surgical data:
Timepoint [8] 0 0
Secondary outcome [9] 0 0
Anatomical extent of surgery (number of spinal levels)
Timepoint [9] 0 0
Secondary outcome [10] 0 0
Highest anatomical surgical level
Timepoint [10] 0 0
Secondary outcome [11] 0 0
Experience level of primary surgeon (trainee or consultant)
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)
Timepoint [12] 0 0
Secondary outcome [13] 0 0
Dural tear at the time of surgery (yes/no)
Timepoint [13] 0 0
Secondary outcome [14] 0 0
Spinal instrumentation (yes/no)
Timepoint [14] 0 0
Secondary outcome [15] 0 0
Other end-points (all at 1, 4, 24 and 48 hours unless stated):
Timepoint [15] 0 0
Secondary outcome [16] 0 0
Cumulative pethidine dose
Timepoint [16] 0 0
Secondary outcome [17] 0 0
Cumulative morphine dose
Timepoint [17] 0 0
Secondary outcome [18] 0 0
VAS scores for pain at rest and during movement
Timepoint [18] 0 0
Secondary outcome [19] 0 0
Sedation score (1 - 4) 16
Timepoint [19] 0 0
Secondary outcome [20] 0 0
VAS scores for nausea, pruritis
Timepoint [20] 0 0
Secondary outcome [21] 0 0
Other adverse events: agitation, tremor, hallucinations, seizure
Timepoint [21] 0 0
Secondary outcome [22] 0 0
Patient satisfaction scale for pain control during study (48 hours)
Timepoint [22] 0 0
48 hours
Secondary outcome [23] 0 0
(very dissatisfied, dissatisfied, neutral, satisfied, very satisfied) 17
Timepoint [23] 0 0
Secondary outcome [24] 0 0
Plasma pethidine and norpethidine levels (24 hours)
Timepoint [24] 0 0
24 hours
Secondary outcome [25] 0 0
Physiotherapy assessment of ability to deep breathe & cough (unable, poor, adequate, good)
Timepoint [25] 0 0
Secondary outcome [26] 0 0
Length of inpatient stay
Timepoint [26] 0 0

Eligibility
Key inclusion criteria
- Adults undergoing lumbar spinal surgery
Minimum age
18 Years
Maximum age
No limit
Gender
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 status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Other
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00163553
Trial related presentations / publications
Public notes

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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00163553