ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611000449932

Ethics application status

Approved

Date submitted

19/04/2011

Date registered

3/05/2011

Date last updated

17/11/2011

Type of registration

Retrospectively registered

Titles & IDs

Public title

Intrauterine Lidocaine versus Placebo in Conjunction with Paracervical Block for Pain Relief During Fractional Curettage: A Randomized Controlled Trial

Scientific title

The effects of intrauterine lidocaine in conjunctive with paracervical block compared to placebo on pain during the procedure, adverse effects and additional drug requirement in women with abnormal uterine bleeding who undergoing fractional and curettage

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Pain score in women with abnormal uterine bleeding who undergoing fractional and curettage

Adverse effects in women with abnormal uterine bleeding who undergoing fractional and curettage

Additional drug requirement in women with abnormal uterine bleeding who undergoing fractional and curettage

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Arm1: Intrauterine lidocaine in conjunction with paracervical block (2% Lidocaine 5 ml intrauterine instillation and paracervical block 5 ml each side), single dose

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Arm2: Intrauterine saline in conjunction with paracervical block (Normal saline 5 ml intrauterine instillation and paracervical block 5 ml each side), single dose

Control group

Placebo

Outcomes

Primary outcome [1]

Pain score

Timepoint [1]

After speculum insertion, During and immediately after the procedure

Secondary outcome [1]

Adverse effects e.g. dizziness, nausea and/or vomiting, postural hypotension, convulsion. These adverse effects will be assessed using questionnaire by nurse who does not involve in the previous procedure.

Timepoint [1]

During, immediately, and until 2 hour after the procedure

Secondary outcome [2]

Additional drug requirement will be assessed by medical record ('yes' or 'no')

Timepoint [2]

During the procedure

Eligibility

Key inclusion criteria

Women with abnormal uterine bleeding who undergoing fractional and curettage

Minimum age

No limit

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Pregnancy
Hx of lidocaine hypersensitivity
Hx of bleeding disorders
Hx of impaired LFT
Taking anti-coagulants
Genital organ infection
Profuse uterine bleeding or vital signs unstable

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 opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

15/11/2010

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

230

Accrual to date

Final

Recruitment outside Australia

Country [1]

Thailand

State/province [1]

Khon Kaen

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Khon Kaen Hospital

Address [1]

56 Srichan Road
Muang
Khon Kaen
40000

Country [1]

Thailand

Primary sponsor type

Hospital

Name

Khon Kaen Hospital

Address

56 Srichan Road
Muang
Khon Kaen
40000

Country

Thailand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Khon Kaen Hospital Ethics Committee

Ethics committee address [1]

56 Srichan Road
Muang
Khon Kaen
40000

Ethics committee country [1]

Thailand

Date submitted for ethics approval [1]

02/08/2010

Approval date [1]

02/11/2010

Ethics approval number [1]

76/01/2553

Summary

Brief summary

Fractional curettage is one of a minor gynecologic procedure, routinely performed in order to diagnosis and treatment in women with abnormal uterine bleeding. Because patient might suffer from pain during the procedure, therefore local anesthesia or analgesics are used to relief pain. Paracervical block has been initiated since 1925. However, its effectiveness in pain reduction during fractional curettage is inconclusive. In some studies, they found that many patients still getting moderate pain and additional painkillers were needed in both during and after the procedure. To our knowledge, the mechanism of action of paracervical block is blocking nerve impulse at uterovaginal plexus (Frankenhauser’s plexus) which provide nerve conduction to cervix and lower uterine segment.  Therefore, paracervical block is inadequate for pain relief in case of performing uterine intervention such as fractional curettage.  Theoretically, intrauterine lidocaine can block nerve conduction at nerve ending providing for endometriuim, corpus and fundus. In practical, intrauterine lidocaine for fractional curettage has not yet widely performed due to its complexity to perform and needed experienced hands. However, There are many studies conducted randomized controlled trial comparing between the Intrauterine lidocaine and paracervical block or other anesthesia or analgesia for pain relief during many gynecologic procedure such as hysteroscopy, endometrial sampling, dilatation curettage, suctional curettage, fractional curettage, removal of lost IUD, etc. The results revealed that intrauterine lidocaine was superior to placebo or other forms of anesthesia in pain reduction with statistically significance.  
No prior systematic review compared between paracervical block alone and paracervical block in conjunctive with intrauterine lidocaine for pain relief during fractional curettage. Hence, the author plan to conduct randomized controlled trial to assess the effectiveness of intrauterine lidocaine for pain reduction in women with abnormal uterine bleeding who undergoing fraction and curettage. Adverse effects of both interventions and additional anesthetic or analgesia requirement are also evaluated.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Nujaree Leelasuwattanakul

Address

Khon Kaen Hospital
56 Srichan Road
Muang
Khon Kaen
40000

Country

Thailand

Phone

66834017488

Fax

6643336789 Ext 3736

kukana_ob@hotmail.com

Contact person for scientific queries

Name

Somsak Pratipanawat

Address

Khon Kaen Hospital
56 Srichan Road
Muang
Khon Kaen
40000

Country

Thailand

Phone

66897143355

Fax

6643336789 Ext 3736

somsak_p@yahoo.com

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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