Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000554662
Ethics application status
Approved
Date submitted
27/11/2008
Date registered
23/05/2014
Date last updated
23/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Prospective Study of the Effects of Pregabalin versus Placebo on the incidence and intensity of pain after video-assisted thoracoscopic surgery.
Scientific title
A Prospective Study of the Effects of Pregabalin versus Placebo on the incidence and intensity of pain after thoracoscopic surgery
Secondary ID [1] 762 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post thoracotomy pain syndrome 4037 0
Condition category
Condition code
Anaesthesiology 4240 4240 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
prevention of long term pain following thorocotomy operation. Intervention involves using 300mg oral pregabalin administered prior to commencement of thoracoscopic surgery (day 1) and continued for a further 5 postoperative days (day 6). Both preoperative pregabalin and postoperative pregabalin are compared with oral placebo. Blinded nursing staff in hospital administering pregabalin/placebo will sign medication chart to confirm that the pregabalin/placebo has been taken by the participant.
Intervention code [1] 3757 0
Prevention
Intervention code [2] 289388 0
Treatment: Drugs
Comparator / control treatment
Control treatment is oral placebo, taken twice daily for 6 days. Placebo is a salt tablet
Control group
Placebo

Outcomes
Primary outcome [1] 5126 0
Average Visual Analogue Scale (VAS) rating with deep breathing versus time for the period of 0 to 9 months after initial video assisted thoracoscopic surgery (VATS). The VAS will be measured postoperatively, at 6 weeks, , and at 3, 6, and 9 months: these scores will be summed then divided by 5 to give the average pain intensity score over the 0 to 9 month post-operative period.
Timepoint [1] 5126 0
from completion of surgery to 9 months after surgery.
Secondary outcome [1] 8629 0
Quantity of opioid use in oral morphine equivalent in milligrams over
i) the first 5 post-operative days
ii) from day 6 (after completion of pregabalin) until 9 months.
Timepoint [1] 8629 0
from commencement of surgery to 9 months after surgery
Secondary outcome [2] 308270 0
Short form McGill questionnaire score change on discharge from hospital and at 9 months after surgery
Timepoint [2] 308270 0
prior to surgery, day 6 after commencment of pregabalin, 6 weeks after surgery, 3 months after surgery, , 6 months after surgery, 9 months after surgery
Secondary outcome [3] 308271 0
SPF-12 score change at hospital admission and at 9 months after surgery
Timepoint [3] 308271 0
from immediately prior to surgery until 9 months after surgery
Secondary outcome [4] 308272 0
change in spirometric lung function
Timepoint [4] 308272 0
from prior to surgery, on day 6 after commencement pregabalin/placebo
Secondary outcome [5] 308376 0
Quality of recovery score
Timepoint [5] 308376 0
before surgery and at 24 hours after surgery

Eligibility
Key inclusion criteria
Patients having video assisted thoracoscopic surgery (VATS)
Conscious
Able to understand use of "PCA" ( Patient Controlled Analgesia)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Morphine or paracetamol contraindication or allergy
Allergy to pregabalin
History of chronic pain
Evolving myocardial infarction, arrhythmias at time of surgery
Preoperative respiratory function tests showing a forced vital capacity<60% predicted, forced expiratory volume 1s <60%, or both
Renal insufficiency (creatinine >15mg/dL)
Liver dysfunction (aspartate aminotransferase, alanine aminotransferase, or both >40u/L)

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)
Patients are located via the operating room list or via pre admission clinic prior to their surgery. Allocation of treatment group is random. That is they receive the next kit number containg the trial medications, that is numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random randomisation assignments
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/10/2007
Actual
10/10/2007
Date of last participant enrolment
Anticipated
1/03/2013
Actual
23/04/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
95
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 1317 0
3004
Recruitment outside Australia
Country [1] 6054 0
Hong Kong
State/province [1] 6054 0
Hong Kong

Funding & Sponsors
Funding source category [1] 4506 0
Commercial sector/Industry
Name [1] 4506 0
Pfizer Pharmaceuticals Investigator initiated funding
Country [1] 4506 0
United States of America
Primary sponsor type
Individual
Name
Dr Alex Konstantatos
Address
C/o Alfred Hospital, Commercial Rd, Melbourne, Victoria Australia 3004
Country
Australia
Secondary sponsor category [1] 3790 0
Hospital
Name [1] 3790 0
Alfred Hospital Research and Ethics Committee
Address [1] 3790 0
Alfred Hosptial.55 Commercial Road, Melbourne, Victoria, Australia, 3004
Country [1] 3790 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6271 0
ALFRED HOSPITAL ETHICS COMMITTEE
Ethics committee address [1] 6271 0
55 Commercial Road, Melbourne. Victoria 3004
Ethics committee country [1] 6271 0
Australia
Date submitted for ethics approval [1] 6271 0
11/05/2006
Approval date [1] 6271 0
12/07/2007
Ethics approval number [1] 6271 0
169 / 06

Summary
Brief summary
The study proposes to investigate whether a drug with specific effects which damp excessive nerve mediated activity can prevent the long term occurence of pain after chest surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29172 0
Dr Alex konstantatos
Address 29172 0
Alfred Hospital
Commercial Rd Melbourne, Victoria, Australia 3004
Country 29172 0
Australia
Phone 29172 0
+61 3 90762000
Fax 29172 0
Email 29172 0
[email protected]
Contact person for public queries
Name 12329 0
Ms Ms. Dana Boyd
Address 12329 0
Anaesthetic Department. Alfred Hospital, 55 Commercial Road Melbourne. Victoira 3004
Country 12329 0
Australia
Phone 12329 0
+61 3 90762648
Fax 12329 0
+61 3 90768076
Email 12329 0
[email protected]
Contact person for scientific queries
Name 3257 0
Dr Dr. Alex Konstantatos
Address 3257 0
Anaesthetic Department. Alfred Hospital, 55 Commercial Road Melbourne. Victoria 3004
Country 3257 0
Australia
Phone 3257 0
+61 3 90762854
Fax 3257 0
+61 3 90762813
Email 3257 0
[email protected]

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
No additional documents have been identified.