Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
IUA
Study hypothesis
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
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Local anesthesia for fractional curettage
Intervention
Intrauterine lidocaine plus paracervical block (experimental group) compared with intrauterine saline plus paracervical block (control group)
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
The reduction of a maximum pain score during fractional curettage.
Secondary outcome measures
Secondary outcomes included pain profile during fractional curettage, number of patients with pain score >4 cm, patientsÂ’ global satisfaction, types and incidence of adverse events, and serum lidocaine profile.
Overall trial start date
01/04/2003
Overall trial end date
31/10/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Women with abnormal uterine bleeding scheduled for fractional curettage.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
70
Participant exclusion criteria
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.
Recruitment start date
01/04/2003
Recruitment end date
31/10/2003
Locations
Countries of recruitment
Thailand
Trial participating centre
Department of Obstetrics and Gynecology
Bangkok
10700
Thailand
Funders
Funder type
Hospital/treatment centre
Funder name
Siriraj Grant for Research Development, Faculty of Medicine, Siriraj Hospital (Thailand)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16135583
Publication citations
-
Results
Rattanachaiyanont M, Leerasiri P, Indhavivadhana S, Effectiveness of intrauterine anesthesia for pain relief during fractional curettage., Obstet Gynecol, 2005, 106, 3, 533-539, doi: 10.1097/01.AOG.0000172424.09992.3e.