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Trial registered on ANZCTR


Registration number
ACTRN12606000064505
Ethics application status
Approved
Date submitted
8/02/2006
Date registered
15/02/2006
Date last updated
15/02/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Double Blind Placebo Controlled Trial of Site Specific Clonidine Patches In Treatment of Neuropathic Wound Pain Following Caesarean Section
Scientific title
A Randomised Double Blind Placebo Controlled Trial of Site Specific Clonidine Patches In Treatment of Neuropathic Wound Pain Following Caesarean Section
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuropathic wound pain following caesarean section 1027 0
Condition category
Condition code
Reproductive Health and Childbirth 1101 1101 0 0
Other surgery
Neurological 1102 1102 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clonidine patch applied to the site of neuropathic pain . Patch to be applied for 24 hours. (clonidine dose in patch = 2.5mg)
Intervention code [1] 888 0
Treatment: Drugs
Comparator / control treatment
placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1469 0
Reduction of neuropathic pain
Timepoint [1] 1469 0
Measured at 24 hours post application of the clonidine patch
Secondary outcome [1] 2635 0
Reduction of antineuropathic pain medication
Timepoint [1] 2635 0
Measured at 24 hours post application of clonidine patch

Eligibility
Key inclusion criteria
patients who fit the following criteria: The diagnostic criteria of Hayes et al (2002) have been modified for this study. They propose that 5 of 8 features suggestive of neuropathic pain need to be present for the diagnosis to be made. One of these features (history consistent with nerve injury) is considered satisfied in all caesarian section patients in view of their surgical history. Another, (associated autonomic features) is neither sought nor seen frequently in caesarian section patients. We are therefore left with 4 of 6 features as follows:1.Pain in the absence of evidence of ongoing tissue damage2.Character of pain from any of: burning, stabbing, pulsing.3.Paroxysmal or spontaneous pain4.Presence of any of: allodynia, hyperalgesia, hyperpathia5.Pain within an area of sensory deficit6.Associated dysaesthesias
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Known previous hypersensitivity to clonidine or clonidine patches2.Current treatment for other neuropathic pain states3.Current treatment with clonidine, tricyclic antidepressants, anti convulsants, or oral sodium channel blockers eg mexiletine.4.Patients who would normally require an interpreter for informed consent or to properly interpret pain scoring.5.Patients with a vertical surgical incision.6.Patients with severe bradyarrythmia due to sick sinus syndrome or 2nd or 3rd degree AV block.7.Discharge or transfer anticipated within following 24 hours8.Refusal of informed consent.9.Patients currently on other antihypertensive agents.10.Patients in whom an ilioinguinal nerve block has been performed.

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)
sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
subjects, therapists and outcome assessors all blinded
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 283 0
New Zealand
State/province [1] 283 0

Funding & Sponsors
Funding source category [1] 1205 0
Hospital
Name [1] 1205 0
Anaesthetic dept, Womens Health, Auckland City Hospital
Country [1] 1205 0
New Zealand
Primary sponsor type
Individual
Name
Tim Short
Address
Country
Secondary sponsor category [1] 1064 0
Government body
Name [1] 1064 0
Auckland Health
Address [1] 1064 0
Country [1] 1064 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2545 0
Auckland Hospital
Ethics committee address [1] 2545 0
Ethics committee country [1] 2545 0
New Zealand
Date submitted for ethics approval [1] 2545 0
Approval date [1] 2545 0
08/11/2005
Ethics approval number [1] 2545 0
NTX/05/03/012 (A+ 3137)

Summary
Brief summary
There will be a research nurse who will randomise and initiate patient treatments (placebo or clonidine) as described below, but who will not participate in any other aspect of the patient’s care or assessment.

A trained collaborator will pack sixty serially numbered envelopes with either active or placebo patch and cover, together with instructions for its use. The envelopes will be prepared in such a way that the contents cannot be determined by feel. They will be held in a box in series order in the anaesthetic department. A master copy of the randomisation code will be held on computer by this collaborator.
Each envelope will contain a slip stating that the patient is to be given clonidine or placebo. In the case of a clonidine allocation the envelope will contain one clonidine TTS-1 patch whose expiry is known to extend beyond the duration of the trial. In the case of a placebo allocation the envelope will contain one square shaped inert patch which will enable the research nurse to simulate application of a patch to the affected area in the placebo patients. Finally, the envelope will contain an opaque occlusive dressing that will be placed over the clonidine patch or bandaid dressing so that neither the patient nor any other staff will be able to determine the treatment allocation.

Once consent is completed, a trained collaborator will draw the next consecutive envelope from the file in the department. They must record the trial number from the envelope in the space provided on the patient’s trial data form (Appendix 2). They will then visit the patient to apply the patch or “placebo patch” as directed by the pain team staff. The patch must be applied directly over the maximally tender point adjacent to the wound. Collaborators must ensure the patient does not watch what they are doing, and should refer to the patch as the “trial patch” rather than a clonidine patch, placebo or any other term that might influence the patient’s perception of their treatment allocation.

The patch will remain in place for 24 hours. The dressing and patch will be removed by a collaborator(research nurse), and the identity of the underlying patch will continue to be concealed from the patient and trial investigators.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36352 0
Address 36352 0
Country 36352 0
Phone 36352 0
Fax 36352 0
Email 36352 0
Contact person for public queries
Name 10077 0
Jane Suckling
Address 10077 0
Anaesthetic Department
Womens Health
Auckland City Hospital
Level 9
Grafton Road
Grafton Auckland
Country 10077 0
New Zealand
Phone 10077 0
+64 2 1468832
Fax 10077 0
Email 10077 0
[email protected]
Contact person for scientific queries
Name 1005 0
Fran Storr
Address 1005 0
Anaesthetic Department
Womens Health
Auckland City Hospital
Level 9
Grafton Road
Grafton Auckland
Country 1005 0
New Zealand
Phone 1005 0
+64 2 1492235
Fax 1005 0
Email 1005 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.