ANZCTR - Registration

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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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

diagnostic hysteroscopy

hysteroscopy for minor procedure

Condition category

Condition code

Surgery

Other surgery

Reproductive Health and Childbirth

Other reproductive health and childbirth disorders

Anaesthesiology

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]

Prevention

Intervention code [2]

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]

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]

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]

b) Need for additional pain relief

Timepoint [2]

as assessed by a phone call on day 3

Secondary outcome [1]

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]

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?

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]

Ipswich Hospice Care - Ipswich

Recruitment postcode(s) [1]

4305 - Bremer

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

West moreton Health Service HREC

Ethics committee address [1]

Human Research Ethics Committee EC00184
The Park – Centre for Mental Health
Locked Bag 500
Sumner Park BC, QLD 4074

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/07/2013

Approval date [1]

30/08/2013

Ethics approval number [1]

HREC/12/QWMS/40,SSA/12/QWMS/41A/22-12

Summary

Brief summary

To see if intra uterine installation of a local anaesthetic  at end of Hysteroscopy procedure reduces post op pain and delay in recovery

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/369217-Hysteroscopy research proposal 120712.docx

Contacts

Principal investigator

Name

A/Prof Kassam Mahomed

Address

Dept of Obstetrics and Gynaecology
Ipswich Hospital
1 Chelmsford Avenue
Ipswich
Qld. 4305

Country

Australia

Phone

+61738101111

Fax

[email protected]

Contact person for public queries

Name

kassam mahomed

Address

Dept of Obstetrics and Gynaecology
Ipswich Hospital
1 Chelmsford Avenue
Ipswich
Qld. 4305

Country

Australia

Phone

+61738101111

Fax

[email protected]

Contact person for scientific queries

Name

Kassam Mahomed

Address

Dept of Obstetrics and Gynaecology
Ipswich Hospital
1 Chelmsford Avenue
Ipswich
Qld. 4305

Country

Australia

Phone

+61738101111

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23814	Other				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.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
4004	Plain language summary	No		Background: Pain after hysteroscopy is usually min... [More Details]
4569	Study results article	Yes		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.

Trial Review

Documents added manually

Documents added automatically