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 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/05/2005
- Registration date
- 08/07/2005
- Last edited
- 10/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Manee Rattanachaiyanont
Scientific
Scientific
Department of Obstetrics and Gynecology
Faculty of Medicine
Siriraj Hospital
2 Prannok Rd.
Bangkoknoi
Bangkok
10700
Thailand
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/04/2003 |
| Completion date | 31/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Thailand
Study participating centre
Department of Obstetrics and Gynecology
Bangkok
10700
Thailand
10700
Thailand
Sponsor information
Mahidol University - Siriraj Grant for Research Development (Thailand)
University/education
University/education
Faculty of Medicine
Siriraj Hospital
Mahidol University
2 Prannok Rd.
Bangkoknoi
Bangkok
10700
Thailand
"ROR" |
https://ror.org/01znkr924 |
|---|
Funders
Funder type
Hospital/treatment centre
Siriraj Grant for Research Development, Faculty of Medicine, Siriraj Hospital (Thailand)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2005 | Yes | No |
