Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000745943
Ethics application status
Approved
Date submitted
14/07/2011
Date registered
15/07/2011
Date last updated
15/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Natural History of the Pudendal Nerve Block
Scientific title
Natural history of Pudendal nerve block in female patients with chronic perineal pain
Secondary ID [1] 262630 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pudendal neuralgia in women 268332 0
Condition category
Condition code
Anaesthesiology 268473 268473 0 0
Anaesthetics
Neurological 268474 268474 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This injection is done by vaginal way, on both sides in the operating theatre under sedation. We inject 10ml of Ropivacaine, an amide-type local anesthetic, at a concentration 0.75% in each Alcock’s canal. We observed that after the block, the different symptoms return at different times after the block.
Intervention code [1] 266979 0
Diagnosis / Prognosis
Intervention code [2] 266987 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269217 0
To identify precisely how long a pudendal nerve block lasts. The questionnaire is based on the seven most commonly observed pain symptoms( rectal pain (irrespective of defaecation), perineal pain, dysuria, vaginal pain, clitoral or labial pain, pain during arousal and pain in the sitting position) in patients, scored using the standardised Visual Analogue Scale (VAS)
Timepoint [1] 269217 0
Form a half hour before surgery, then 30 mins, 6 hours, 12 hours, 20 hours, 28 hours 36 hours, 44 hrs and 52 hours after block.
Secondary outcome [1] 279140 0
To determine how the different symptoms of pudendal neuralgia presented by the patient, evolve following the pudendal nerve block. This will be done by questionnaires( Visual Analogue Scale (VAS))completed by the patients before and then at regular intervals after the block
Timepoint [1] 279140 0
The questionnaires will be completed at 6hrs, 12hrs, 20 hrs and 28hrs, 36hrs 44hrs and 52 hrs after block.
If later on the patient undergoes the pudendal nerve release surgery, the same three part questionnaire will be used to observe the evolution of the symptoms after surgery. The
patient will fill in that questionnaire at different times:
1. 3 months after surgery.
2. 6 months after surgery.
3. 1 year after surgery.

Eligibility
Key inclusion criteria
1) Sex: female.
2) Age range: 18+ years.
3) Diagnosis of Pudendal neuralgia according to the Aix-en-Provence Team criteria.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Significant psycho-social disorders.
2.Inability to understand the questionnaire during the first appointment.
3.History of neurologic or neuromuscular disorder.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All eligible women in whom a pudendal nerve block is performed as a diagnostic tool for pudendal nerve entrapment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267460 0
Other
Name [1] 267460 0
Barbara Gross Research Unit
Country [1] 267460 0
Australia
Primary sponsor type
Hospital
Name
Royal Hospital for Women
Address
Barker street, Rankwick NSW 2031
Country
Australia
Secondary sponsor category [1] 266498 0
None
Name [1] 266498 0
Address [1] 266498 0
Country [1] 266498 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269419 0
the South Eastern Sydney and Illawarra Area Health Services (SESIAHS) Northern Sector Human Research Ethics Committee
Ethics committee address [1] 269419 0
POWH,
Barker street, Randwick, NSW 2031
Ethics committee country [1] 269419 0
Australia
Date submitted for ethics approval [1] 269419 0
Approval date [1] 269419 0
11/08/2008
Ethics approval number [1] 269419 0
1/08/0095

Summary
Brief summary
The firsrt aim of the study is to identify precisely how long a pudendal nerve block lasts and to find out how the
different symptoms of pudendal neuralgia presented by the patient, evolve during the 52 hours following the pudendal
nerve block.
The second aim is to find out, for patients undergoing afterwards the pudendal nerve release surgery, if there is a
correlation between the particular response to pudendal nerve block and the outcome after surgery.
This will be a prospective study based on questionnaires.
It will include a minimum of 50 women aged 18 or more, who had been referred to the Pudendal nerve Clinic in the
Endogynaecology Department at the Royal Hospital for Women, who meet the entry criteria and who already
consented to undergo a pudendal nerve block as part of their assessment.
The participant will be asked to fill in a questionnaire, always the same, about her symptoms before, just after and then every 6 then 8 hours for 52 hours after the pudendal nerve block.
If the patient undergoes a surgery to release the pudendal nerve entrapment, we will ask her to fill in that same
questionnaire again 3, 6 and 12 months after the surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32879 0
Address 32879 0
Country 32879 0
Phone 32879 0
Fax 32879 0
Email 32879 0
Contact person for public queries
Name 16126 0
Dr Thierry Vancaillie
Address 16126 0
Royal Hospital for Women
Barker street, Randwick
NSW 2031
Country 16126 0
Australia
Phone 16126 0
1300 722 206
Fax 16126 0
+61 2 9382 6244
Email 16126 0
[email protected]
Contact person for scientific queries
Name 7054 0
Dr Thierry Vancaillie
Address 7054 0
Royal Hospital for Women
Barker Street, Randwick
NSW 2031
Country 7054 0
Australia
Phone 7054 0
1300722206
Fax 7054 0
+61 29382 6244
Email 7054 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
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