Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001378314
Ethics application status
Approved
Date submitted
14/09/2017
Date registered
28/09/2017
Date last updated
6/05/2019
Date data sharing statement initially provided
6/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Adding hyaluronic acid to pudendal nerve blocks for treatment of pudendal neuralgia
Scientific title
Randomised cross-over trial assessing the efficacy of adding hyaluronic acid to local anaesthetic in pudendal nerve blocks in the treatment of pudendal neuralgia
Secondary ID [1] 292889 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pudendal neuralgia 304735 0
Condition category
Condition code
Anaesthesiology 304052 304052 0 0
Pain management
Neurological 304212 304212 0 0
Other neurological disorders
Renal and Urogenital 304213 304213 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised cross-over trial looking at the efficacy of adding hyaluronic acid to local anaesthetic when performing pudendal nerve blocks for the treatment of pudendal neuralgia.

Medication;
- levobupivicaine 0.5% 3ml
- 3ml hyaluronic acid 1% OR 3ml placebo gel
- deep tissue neural block performed via a transgluteal approach under x-ray guidance
- two treatments
- treatments consist of either a unilateral or bilateral block (depending on patient symptoms) and are performed on two occasions with a 3 month wash out period between
Intervention code [1] 299126 0
Treatment: Drugs
Comparator / control treatment
Hyaluronic acid is a glycosaminoglycan present within the body and is thought to improve analgesia by restoration of the extracellular matrix. It is available in commercial preparations eg Juvaderm. In our study it will be compounded in a concentration of 1% and appears as a gel solution. 3ml of solution will be used for each nerve block.
The control arm will receive an identical gel solution that does not contain hyaluronic acid.
Control group
Placebo

Outcomes
Primary outcome [1] 303384 0
Pain relief using BPI-SF
Timepoint [1] 303384 0
1, 6 and 12 weeks post treatment
Secondary outcome [1] 338808 0
Pain interference with function using BPI-SF
Timepoint [1] 338808 0
1, 6 and 12 weeks post treatment
Secondary outcome [2] 338809 0
Change in analgesia use according to patient self report questionnaire
Timepoint [2] 338809 0
12 weeks after treatment

Eligibility
Key inclusion criteria
Clinical diagnosis of pudendal neuralgia
No previous pudendal nerve block
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous pudendal nerve block

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)
Allocation will occur after enrolment.
It will be performed by the pharmacy compounding the solutions and not available to other study staff.
Randomisation will be by numbered opaque envelopes and involve stratification for gender and blocking to ensure even numbers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted blocking will be performed using computer software with stratification according to gender.
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
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Students t-test to compare pain scores pre and post procedure at time slots of 1, 6 and 12 weeks and 6 months after trial completion.
The issue of multiple comparisons will be taken into consideration during the analysis.
Similar analysis of pain interference.
Descriptive statistics will be used for changes in analgesic use.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/01/2018
Actual
23/05/2018
Date of last participant enrolment
Anticipated
30/06/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
103
Accrual to date
35
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9030 0
Prince of Wales Private Hospital - Randwick
Recruitment postcode(s) [1] 17510 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 297519 0
Other
Name [1] 297519 0
Women's Health and Research Institute of Australia (WHRIA)
Country [1] 297519 0
Australia
Primary sponsor type
Other
Name
WHRIA
Address
Level 12, 97-99 Bathurst St Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 296526 0
None
Name [1] 296526 0
Address [1] 296526 0
Country [1] 296526 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298618 0
Belberry
Ethics committee address [1] 298618 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 298618 0
Australia
Date submitted for ethics approval [1] 298618 0
02/10/2017
Approval date [1] 298618 0
09/03/2018
Ethics approval number [1] 298618 0

Summary
Brief summary
This study is a randomised cross-over trial assessing the efficacy of the addition of hyaluronic acid (HA) to levobupivicane in pudendal nerve blockade as a treatment for pudendal neuralgia. Previous studies have demonstrated that application of local anaesthetic along the path of the pudendal nerve results in the onset of numbness and a reduction in symptoms. This result is however, most often limited from a few hours to a few days . Recent studies have suggested that the addition of hyaluronic acid to the local anaesthetic blockade can result in improved and prolonged analgesia. AIM; to determine whether the addition of hyaluronic acid to local anaesthetic results in improved post-blockade pain scores, change in medication use and change in pain interference in daily activities. MATERIALS AND METHODS; This is a triple-blind randomised cross-over study in which each participant will receive two pudendal nerve blocks 3 months apart one of which will contain hyaluronic acid + levobupivicaine and the other placebo + levobupivicaine. Assessment of symptoms and effect on function will be via use of The Brief pain inventory – short form. We will also assess analgesia use pre and post blockade. RESULTS; Differences in pain and function scores pre and post blockade will be assessed using the students t-test with adjustments made for multiple comparisons. We will also use descriptive statistics to review any changes in medication use.
CONCLUSION; if our null hypothesis is true we would expect to see no difference between HA acid and placebo. However, if the HA is effective then we would hope to see improved pain scores, decreased pain interference with life and potentially decreased medication use.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2758 2758 0 0
/AnzctrAttachments/373651-ApprovalLetter-HREC2017-09-690.pdf (Ethics approval)

Contacts
Principal investigator
Name 77662 0
Dr Lauren Kite
Address 77662 0
Women's health and research institute of Australia
Level 12, 97-99 Bathurst St Sydney NSW 2000
Country 77662 0
Australia
Phone 77662 0
+61419160667
Fax 77662 0
Email 77662 0
laurenkite@gmail.com
Contact person for public queries
Name 77663 0
Dr Lauren Kite
Address 77663 0
Women's health and research institute of Australia
Level 12, 97-99 Bathurst St Sydney NSW 2000
Country 77663 0
Australia
Phone 77663 0
1300 722206
Fax 77663 0
Email 77663 0
info@whria.com.au
Contact person for scientific queries
Name 77664 0
Dr Lauren Kite
Address 77664 0
Women's health and research institute of Australia
Level 12, 97-99 Bathurst St Sydney NSW 2000
Country 77664 0
Australia
Phone 77664 0
+61419160667
Fax 77664 0
Email 77664 0
laurenkite@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23561Ethical approval    373651-(Uploaded-13-04-2021-16-00-16)-Study-related document.pdf

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.