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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03075358 |
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Date of registration:
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06/03/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of Lidocaine Spray for Reducing Pain During Endometrial Aspiration Biopsy : a Randomized Controlled Trial
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Scientific title:
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Effects of Lidocaine Spray for Reducing Pain During Endometrial Aspiration Biopsy : a Randomized Controlled Trial |
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Date of first enrolment:
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March 6, 2017 |
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Target sample size:
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240 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03075358 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Ratpaporn Piyawetchakarn, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculty of Medicine, Chiang Mai University |
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Name:
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Kittipat Charoenkwan, MD, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculty of Medicine, Chiang Mai University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women undergoing endometrial aspiration biopsy at Maharaj Nakorn Chiang Mai hospital
Exclusion Criteria:
- Lidocaine allergy
- Pregnancy
- Previous uterine or cervical surgical procedures
- Neurological abnormalities
- Coagulopathy
- Infection of cervix, vagina, or pelvic cavity
- Taking any analgesic drugs within 4 hours before the procedure
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Uterine Bleeding
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Intervention(s)
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Drug: Lidocaine spray
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Other: Normal saline spray
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Primary Outcome(s)
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Aspiration pain
[Time Frame: Immediately following endometrial aspiration biopsy]
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Postprocedure pain
[Time Frame: 10 minute after procedure completion]
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Secondary ID(s)
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OBG-2559-04137
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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