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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

Condition category

Condition code

Reproductive Health and Childbirth

Other surgery

Neurological

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]

Treatment: Drugs

Comparator / control treatment

placebo

Control group

Placebo

Outcomes

Primary outcome [1]

Reduction of neuropathic pain

Timepoint [1]

Measured at 24 hours post application of the clonidine patch

Secondary outcome [1]

Reduction of antineuropathic pain medication

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Anaesthetic dept, Womens Health, Auckland City Hospital

Address [1]

Country [1]

New Zealand

Primary sponsor type

Individual

Name

Tim Short

Address

Country

Secondary sponsor category [1]

Government body

Name [1]

Auckland Health

Address [1]

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Auckland Hospital

Ethics committee address [1]

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

08/11/2005

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Jane Suckling

Address

Anaesthetic Department
Womens Health
Auckland City Hospital
Level 9
Grafton Road
Grafton Auckland

Country

New Zealand

Phone

+64 2 1468832

Fax

[email protected]

Contact person for scientific queries

Name

Fran Storr

Address

Anaesthetic Department
Womens Health
Auckland City Hospital
Level 9
Grafton Road
Grafton Auckland

Country

New Zealand

Phone

+64 2 1492235

Fax

[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.

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