Trial Review

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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] 252851 0
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 258370 0
Adverse effects in women with abnormal uterine bleeding who undergoing fractional and curettage 258371 0
Additional drug requirement in women with abnormal uterine bleeding who undergoing fractional and curettage 258372 0
Condition category
Condition code
Anaesthesiology 258545 258545 0 0
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] 257369 0
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] 259381 0
Pain score
Timepoint [1] 259381 0
After speculum insertion, During and immediately after the procedure
Secondary outcome [1] 265910 0
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] 265910 0
During, immediately, and until 2 hour after the procedure
Secondary outcome [2] 265911 0
Additional drug requirement will be assessed by medical record ('yes' or 'no')
Timepoint [2] 265911 0
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?
No
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] 2963 0
Thailand
State/province [1] 2963 0
Khon Kaen

Funding & Sponsors
Funding source category [1] 258536 0
Hospital
Name [1] 258536 0
Khon Kaen Hospital
Country [1] 258536 0
Thailand
Primary sponsor type
Hospital
Name
Khon Kaen Hospital
Address
56 Srichan Road
Muang
Khon Kaen
40000
Country
Thailand
Secondary sponsor category [1] 257673 0
None
Name [1] 257673 0
Address [1] 257673 0
Country [1] 257673 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260506 0
Khon Kaen Hospital Ethics Committee
Ethics committee address [1] 260506 0
56 Srichan Road
Muang
Khon Kaen
40000
Ethics committee country [1] 260506 0
Thailand
Date submitted for ethics approval [1] 260506 0
02/08/2010
Approval date [1] 260506 0
02/11/2010
Ethics approval number [1] 260506 0
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 31755 0
Address 31755 0
Country 31755 0
Phone 31755 0
Fax 31755 0
Email 31755 0
Contact person for public queries
Name 15002 0
Nujaree Leelasuwattanakul
Address 15002 0
Khon Kaen Hospital
56 Srichan Road
Muang
Khon Kaen
40000
Country 15002 0
Thailand
Phone 15002 0
66834017488
Fax 15002 0
6643336789 Ext 3736
Email 15002 0
[email protected]
Contact person for scientific queries
Name 5930 0
Somsak Pratipanawat
Address 5930 0
Khon Kaen Hospital
56 Srichan Road
Muang
Khon Kaen
40000
Country 5930 0
Thailand
Phone 5930 0
66897143355
Fax 5930 0
6643336789 Ext 3736
Email 5930 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

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