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

ISRCTN	ISRCTN02384619
DOI	https://doi.org/10.1186/ISRCTN02384619
Protocol serial number	N/A
Sponsor	Mahidol University - Siriraj Grant for Research Development (Thailand)
Funder	Siriraj Grant for Research Development, Faculty of Medicine, Siriraj Hospital (Thailand)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Manee Rattanachaiyanont
Scientific

Department of Obstetrics and Gynecology
Faculty of Medicine
Siriraj Hospital
2 Prannok Rd.
Bangkoknoi
Bangkok
10700
Thailand

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	IUA
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	The reduction of a maximum pain score during fractional curettage.
Key secondary outcome measure(s)	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.
Completion date	31/10/2003

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	70
Key inclusion criteria	Women with abnormal uterine bleeding scheduled for fractional curettage.
Key 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.
Date of first enrolment	01/04/2003
Date of final enrolment	31/10/2003

Department of Obstetrics and Gynecology

Bangkok
10700
Thailand

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2005		Yes	No