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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.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT03134391
Date of registration: 25/04/2017
Prospective Registration: No
Primary sponsor: Indonesia University
Public title: Comparison Between Vapocoolant Spray and Eutectic Mixture of Local Anesthetics in Reducing Pain From Spinal Injection
Scientific title: Comparison Between Vapocoolant Spray and Eutectic Mixture of Local Anesthetics in Reducing Pain From Spinal Injection
Date of first enrolment: August 1, 2016
Target sample size: 97
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03134391
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Indonesia
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- woman aged >18 years old

- American Society of Anesthesiologists (ASA) physical status I-III who were planned to
undergo one-day care elective surgery at operating room in spinal anesthesia

- patients who were planned to undergo brachytherapy

Exclusion Criteria:

- Subjects with history of allergy to anesthetic agents

- unstable hemodynamic

- history of active psychotropic drug consumption

- spinal anesthesia contraindications such as local infection, severe coagulopathy,
severe hypovolemia, or increased intracranial pressure



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Adult Patient Undergoing Elective Surgery With Spinal Anesthesia
Intervention(s)
Drug: Vapocoolant spray, EMLA
Primary Outcome(s)
VAS [Time Frame: Day 1]
Vital signs [Time Frame: day 1]
Secondary Outcome(s)
Secondary ID(s)
IndonesiaUAnes012
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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