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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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TCTR |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
TCTR20150629005 |
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Date of registration:
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29/06/2015 |
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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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Low Dose Spinal Bupivacaine Decrease Incidence of Postoprative Urinary Retention in Anorectal Surgery
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Scientific title:
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Low Dose Spinal Bupivacaine Decrease Incidence of Postoprative Urinary Retention in Anorectal Surgery |
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Date of first enrolment:
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30/06/2015 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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https://www.thaiclinicaltrials.org/show/TCTR20150629005 |
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Study type:
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Interventional |
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Study design:
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Randomized
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Phase:
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Phase 2
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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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Thanyalak
Thamjamrassri |
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Address:
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270 Rama Road VI Ratchathevi
10400
Bangkok
Thailand |
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Telephone:
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6622011513 |
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Email:
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pika_joy@hotmail.com |
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Affiliation:
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Ramathibodi hospital |
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Name:
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Ratikorn
Wangwarunyoo |
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Address:
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146 Kridsadanakorn20 village Phutthamonthon sai2 road Salathammasop Thaweewatthana
10170
Bangkok
Thailand |
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Telephone:
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66894534991 |
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Email:
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ampam_wang@hotmail.com |
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Affiliation:
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Ramathibodi hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: anorectal surgery
spinal anesthesia
informed consent
Exclusion criteria: predisposing urinary symptom
benign prostate hypertrophy
diabetes mellitus
contraindication for parecoxib and etoricoxib
refuse to participate
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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urinary retention
spinal anesthesia
low dose bupivacaine
anorectal surgery
hemorrhoidectomy
fistulectomy
sphincterectomy
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urinary retention
urinary retention
spinal anesthesia
low dose bupivacaine
anorectal surgery
hemorrhoidectomy
fistulectomy
sphincterectomy
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Intervention(s)
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low dose spinal bupivacaine,conventional dose spinal bupivacaine
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Active Comparator Drug,Active Comparator Drug
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spinal anesthesia with 0.5%bupivacaine (Heavy Marcaine) 0.6ml (3mg) in sitting position for 5 minute,spinal anesthesia with 0.5%bupivacaine (Heavy Marcaine) 1.2ml (6mg) in sitting position for 5 minute
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Primary Outcome(s)
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postoperative urinary retention 24 hours need for urinary catheterization
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Secondary Outcome(s)
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adequacy of anesthesia intraoperative need for other rescue drug
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Secondary ID(s)
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nil known
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Source(s) of Monetary Support
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Faculty of Medicine Ramathibodi Hospital, Mahidol university
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Ethics review
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Status: Submitted, approved
Approval date:
Contact:
Committee on Human Rights Related to Research Involving Human Subjects
6622011000 Ext.
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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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01/12/2016 |
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URL:
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