Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000223639
Ethics application status
Approved
Date submitted
24/08/2005
Date registered
26/08/2005
Date last updated
26/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The GABA Study
Scientific title
Single-dose Pregabalin in Postoperative Pain Relief after Minor Gynaecological Surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of Postoperative Pain 309 0
Condition category
Condition code
Alternative and Complementary Medicine 351 351 0 0
Pain management
Surgery 352 352 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single-dose pregabalin 100 mg administered 1-2 hours pre-operatively, effect on postoperative pain assessed.
Intervention code [1] 247 0
Prevention
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 406 0
Pain as assessed by visual analogue scale.
Timepoint [1] 406 0
Immediately postoperatively and at 1, 2 and 24 hours.
Primary outcome [2] 407 0
Pain on movement and score for cramping pain also assessed.
Timepoint [2] 407 0
Immediately postoperatively and at 1, 2 and 24 hours.
Secondary outcome [1] 876 0
Total dose of fentanyl used intraoperatively and in recovery.
Timepoint [1] 876 0
Secondary outcome [2] 877 0
Total doses of other analgesics used postoperatively.
Timepoint [2] 877 0
Secondary outcome [3] 878 0
Presence of nausea or vomiting.
Timepoint [3] 878 0
Secondary outcome [4] 879 0
Presence of side effects of pregabalin:
headache, lightheadedness, drowsiness, ataxia, visual disturbance.
Timepoint [4] 879 0
Secondary outcome [5] 880 0
Quality of Recovery score
Timepoint [5] 880 0
At 2 and 24 hours postoperatively.
Secondary outcome [6] 881 0
Modified Brief Pain Inventory Short Form
Timepoint [6] 881 0
At 24 hours.
Secondary outcome [7] 882 0
Health Outcome Recovery Survey
Timepoint [7] 882 0
At 24 hours.

Eligibility
Key inclusion criteria
Undergoing minor gynaecological surgery on uterus/cervix without skin or mucosal incision, i.e. D&C +/- Hysteroscopy. ASA 1 or 2.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to pregabalin.History of chronic pelvic pain.Receiving preoperative misoprostol.Currently taking opioids or other forms of pain relief, sedatives or anticonvulsants.Preoperative history of dizziness or severe headaches.Petient request for sedative/anxiolytic premedication.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers of drug or placebo (identical capsules), randomised and prepared by pharmacy. Double blinded until all patients recruited and assessment finished.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 411 0
Commercial sector/Industry
Name [1] 411 0
Pfizer Global Pharmaceuticals
Country [1] 411 0
Primary sponsor type
Individual
Name
Professor Michael Paech
Address
King Edward Memorial Hospital
374 Bagot Road
Subiaco
Perth WA 6008
Country
Australia
Secondary sponsor category [1] 332 0
None
Name [1] 332 0
Not applicable
Address [1] 332 0
Country [1] 332 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1392 0
King Edward Memorial Hospital
Ethics committee address [1] 1392 0
374 Bagot Road, Subiaco, Perth, WA 6008
Ethics committee country [1] 1392 0
Australia
Date submitted for ethics approval [1] 1392 0
Approval date [1] 1392 0
Ethics approval number [1] 1392 0

Summary
Brief summary
Women undergoing D&C surgery often experience pain afterwards between 2 and 7 on a scale of 1-10. This pain is intially due to surgical trauma but may continue because of resulting inflammation. If the ongoing cycle of inflammation is reduced pain may be less. Pregabalin is a treatment for seizure disorders. It also has pain relieving and calming properties. It can reduce local tissue inflammation and the release of pain mediators. Therefore pregabalin given preoperatively may reduce postoperative pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36179 0
Address 36179 0
Country 36179 0
Phone 36179 0
Fax 36179 0
Email 36179 0
Contact person for public queries
Name 9436 0
Professor Michael Paech or Research Nurses: Desiree Cavill & Tracy Bingham
Address 9436 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco Perth WA 6008
Country 9436 0
Australia
Phone 9436 0
+61 8 93402222 Pager 3223 (Mike Paech) or 3433 (Research Nurses)
Fax 9436 0
+61 8 93402260
Email 9436 0
Michael.Paech@health.wa.gov.au
Contact person for scientific queries
Name 364 0
Professor Michael Paech
Address 364 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco Perth WA 6008
Country 364 0
Australia
Phone 364 0
+61 8 93402222 Pager 3223
Fax 364 0
+61 8 93402260
Email 364 0
Michael.Paech@health.wa.gov.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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