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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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16 March 2015 |
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Main ID: |
NCT02387060 |
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Date of registration:
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25/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Use of Intrathecal Fentanyl and Development of Hyperalgesia in Patients Undergoing Elective Cesarean
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Scientific title:
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Use of Intrathecal Fentanyl and Development of Hyperalgesia in Patients Undergoing Elective Cesarean |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02387060 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Chile
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Contacts
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Name:
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Hernan Auad, MD |
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Address:
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Telephone:
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56982933226 |
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Email:
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hernan_auad@hotmail.com |
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Affiliation:
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Name:
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Juan Carlos De la Cuadra, MD |
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Address:
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Telephone:
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+56-2-23543270 |
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Email:
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juancarl@med.puc.cl |
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Affiliation:
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Name:
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Luis I Cortinez, 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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Ponticia Universidad Católica |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Pregnant 37 to 41 weeks.
- American Society of Anesthesiologists classificationI or II.
- Between 18 and 40 years.
- Scheduled for elective cesarean section under spinal anesthesia in the Maternity
Service of the Clinical Hospital of the Catholic University.
Exclusion Criteria:
- Background Of high risk pregnancy. Twin-pregnancy.
- Obesity> 30 kg / m 2 before pregnancy.
- Background Of psychiatric illness.
- Using Chronic analgesic.
- AllergyDrug used in protocol.
- require General anesthesia during surgery
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Complications; Cesarean Section
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Intervention(s)
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Drug: Fentanyl
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Drug: H-Bupivacaine
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Primary Outcome(s)
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Change in Punctate - Von frey (grams)
[Time Frame: Change from Baseline in punctate sensibility at 48 hours]
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Secondary Outcome(s)
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Change in Pressure pain - algometer (kg/cm/cm)
[Time Frame: Change from Baseline in pressure pain at 48 hours]
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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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