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ISRCTN
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ISRCTN02384619
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ClinicalTrials.gov identifier
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Public title
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A double blind randomised placebo-controlled trial to compare the effectiveness of paracervical block plus Intrauterine anesthesia and paracervical block alone for pain relief during fractional durettage
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Scientific title
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Acronym
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IUA
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Serial number at source
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N/A
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Study hypothesis
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Compared with paracervical block alone, intrauterine anesthesia plus paracervical block would reduce maximum pain during fractional curettage for at least 2 cm, as measured by a 10-cm visual analogue score
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Thailand
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Disease/condition/study domain
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Local anesthesia for fractional curettage
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Participants - inclusion criteria
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Women with abnormal uterine bleeding scheduled for fractional curettage.
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Participants - exclusion criteria
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Patients who had the American Society of Anesthesiologists (ASA) physical status >II, genital organ infection, profuse uterine bleeding, a history of lidocaine hypersensitivity, a history of impaired liver function, were virgin, pregnant, or unable to understand how to score a 10-cm visual analogue scale (VAS) pain score.
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Anticipated start date
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01/04/2003
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Anticipated end date
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31/10/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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70
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Interventions
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Intrauterine lidocaine plus paracervical block (experimental group) compared with intrauterine saline plus paracervical block (control group)
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Primary outcome measure(s)
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The reduction of a maximum pain score during fractional curettage.
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Secondary outcome measure(s)
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Secondary outcomes included pain profile during fractional curettage, number of patients with pain score >4 cm, patients’ global satisfaction, types and incidence of adverse events, and serum lidocaine profile.
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Sources of funding
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Siriraj Grant for Research Development, Faculty of Medicine, Siriraj Hospital (Thailand)
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Trial website
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Publications
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2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16135583
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Contact name
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Dr
Manee
Rattanachaiyanont
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Address
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Department of Obstetrics and Gynecology
Faculty of Medicine
Siriraj Hospital
2 Prannok Rd.
Bangkoknoi
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City/town
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Bangkok
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Zip/Postcode
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10700
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Country
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Thailand
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Sponsor
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Mahidol University - Siriraj Grant for Research Development (Thailand)
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Address
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Faculty of Medicine
Siriraj Hospital
Mahidol University
2 Prannok Rd.
Bangkoknoi
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City/town
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Bangkok
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Zip/Postcode
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10700
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Country
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Thailand
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Date applied
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08/05/2005
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Last edited
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10/09/2009
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Date ISRCTN assigned
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08/07/2005
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