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Trial registered on ANZCTR


Registration number
ACTRN12615001214527
Ethics application status
Approved
Date submitted
30/08/2015
Date registered
6/11/2015
Date last updated
6/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intrauterine local anaesthetic after hysteroscopy to reduce post operative pain - A Randomised controlled trial
Scientific title
women undergoing hysteroscopy for diagnosis, insertion of mirena and or removal of a polyp will be randomised to receive intrauterine installation of a local anaesthetic solution or saline at end of procedure to assess any difference in pain and return to normal activity
Secondary ID [1] 287374 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diagnostic hysteroscopy 296058 0
hysteroscopy for minor procedure 296059 0
Condition category
Condition code
Surgery 296324 296324 0 0
Other surgery
Reproductive Health and Childbirth 296390 296390 0 0
Other reproductive health and childbirth disorders
Anaesthesiology 296391 296391 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
10 mls of 0.75% (75mg) Chirocaine solution installed into the uterine cavity at the completion of the procedure.
A trials register in theatre will keep a record of all women recruited.
Intervention code [1] 292719 0
Prevention
Intervention code [2] 293204 0
Treatment: Drugs
Comparator / control treatment
Women will have 10 mls of normal saline administered in the same manner.
Control group
Placebo

Outcomes
Primary outcome [1] 295978 0
a) Pain score –on a score of 1-10 (1 being minimal and 10 being severe) at 2 hours and 24 hours post-operatively

Timepoint [1] 295978 0
at 2 hours as assessed by the recovery staff
a phone call on day 3 will ask about pain needs in the first 24 hours
Primary outcome [2] 296034 0
b) Need for additional pain relief
Timepoint [2] 296034 0
as assessed by a phone call on day 3
Secondary outcome [1] 317086 0
a) time of return to normal activity - assessed on the phone using a couple of simple questions:
1.. Day when returned to normal activity:

2. Did she contact GP due to pain that stopped her from doing normal activity:
Timepoint [1] 317086 0
3 days post operative

Eligibility
Key inclusion criteria
These will be women being booked for hysteroscopy for diagnosis, insertion of Mirena and or removal of a polyp
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with chronic pain
Known allergy to local anaesthetic

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)
Women will be seen at the Gynaecology clinic where a decision is usually made to perform hysteroscopy. At the time of consenting for the operation women will also be provided information regarding the study. After discussion demographic characteristics of the women consenting to participate will be recorded on the data sheet. This is purely to demonstrate that the two groups were comparable.

Randomisation will be using a computer generated variable block of random numbers. Allocation to treatment or control group will be by opening a sequentially numbered opaque sealed envelope available in theatre and opened towards the end of the procedure. The envelopes and randomization schedule will be prepared by a member of the research team not involved in the care of the woman.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be using a computer generated variable block of random numbers
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
Assume that the current incidence of need for additional post-operative analgesia is 20%.For a reduction to 10% with 80 % power and an alpha error of 0.05 we would need 219 women in each group. To allow for attrition we will have a sample size of 225 in each group.

Relative risks with their 95% confidence intervals.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2014
Actual
8/09/2014
Date of last participant enrolment
Anticipated
31/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4275 0
Ipswich Hospice Care - Ipswich
Recruitment postcode(s) [1] 10224 0
4305 - Bremer

Funding & Sponsors
Funding source category [1] 291936 0
Self funded/Unfunded
Name [1] 291936 0
Country [1] 291936 0
Primary sponsor type
Individual
Name
Kassam Mahomed
Address
Dept of Obstetrics and Gynaecology
Ipswich Hospital
1 Chelmsford Avenue
Ipswich
Qld. 4305
Country
Australia
Secondary sponsor category [1] 290605 0
None
Name [1] 290605 0
Address [1] 290605 0
Country [1] 290605 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293437 0
West moreton Health Service HREC
Ethics committee address [1] 293437 0
Ethics committee country [1] 293437 0
Australia
Date submitted for ethics approval [1] 293437 0
12/07/2013
Approval date [1] 293437 0
30/08/2013
Ethics approval number [1] 293437 0
HREC/12/QWMS/40,SSA/12/QWMS/41A/22-12

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 548 548 0 0
/AnzctrAttachments/369217-Hysteroscopy research proposal 120712.docx

Contacts
Principal investigator
Name 59926 0
A/Prof Kassam Mahomed
Address 59926 0
Dept of Obstetrics and Gynaecology
Ipswich Hospital
1 Chelmsford Avenue
Ipswich
Qld. 4305
Country 59926 0
Australia
Phone 59926 0
+61738101111
Fax 59926 0
Email 59926 0
kassam_mahomed@health.qld.gov.au
Contact person for public queries
Name 59927 0
kassam mahomed
Address 59927 0
Dept of Obstetrics and Gynaecology
Ipswich Hospital
1 Chelmsford Avenue
Ipswich
Qld. 4305
Country 59927 0
Australia
Phone 59927 0
+61738101111
Fax 59927 0
Email 59927 0
kassam_mahomed@health.qld.gov.au
Contact person for scientific queries
Name 59928 0
Kassam Mahomed
Address 59928 0
Dept of Obstetrics and Gynaecology
Ipswich Hospital
1 Chelmsford Avenue
Ipswich
Qld. 4305
Country 59928 0
Australia
Phone 59928 0
+61738101111
Fax 59928 0
Email 59928 0
kassam_mahomed@health.qld.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23814Other    MAHOMED K, MCLEAN J, AHMED M et al. Intrauterine a... [More Details]

Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4004Plain language summaryNo Background: Pain after hysteroscopy is usually min... [More Details]
4569Study results articleYes 2016 publication MAHOMED K, MCLEAN J, AHMED M e... [More Details] 369217-(Uploaded-28-01-2020-08-27-19)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.