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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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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2016/12/007516 |
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Date of registration:
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01-12-2016 |
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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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Comparison of effects of two local anesthetic drugs levobupivacaine and bupivacaine combined with an opioid named fentanyl in spinal anesthesia in patients of Medical Termination of Pregnancy with sterilization surgery
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Scientific title:
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A comparative study of intrathecal low dose hyperbaric levobupivacaine (0.5%) plus fentanyl and low dose hyperbaric bupivacaine (0.5%) plus fentanyl in patients undergoing Medical Termination of Pregnancy with sterilization |
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Date of first enrolment:
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04-02-2013 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=14355 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group Trial
Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded
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Phase:
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Phase 2/ Phase 3
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Countries of recruitment
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India
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Contacts
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Name:
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Sakshi Thakore
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Address:
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26/26, Gayatri Nagar,Civil Lines Road,Bundi,Rajasthan, 323001
323001
Bundi, RAJASTHAN
India |
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Telephone:
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9571241824 |
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Email:
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drsakshiarora88@gmail.com |
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Affiliation:
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S.M.S. Medical College and Hospital ,Jaipur |
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Name:
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Dr Rama Chatterji
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Address:
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31,Sangram Colony, C Scheme, Jaipur, Rajasthan, 302001
323001
Jaipur, RAJASTHAN
India |
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Telephone:
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9571241824 |
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Email:
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drsakshiarora88@gmail.com |
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Affiliation:
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S.M.S. Medical College and Hospital ,Jaipur |
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Key inclusion & exclusion criteria
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Inclusion criteria: Weight 40-70 kg, Height >145 cm,ASA I-II, Patients under Medical Termination of Pregnancy with sterilisation
Exclusion criteria: Patients with uncontrolled hypertension ,Infection at injection site, Coagulation disorder, Neurological disease, Patient refusal
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Pregnant females upto 12 weeks posted for Medical Termination of Pregnancy and sterilisation surgery
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Intervention(s)
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Intervention1: Fentanyl: Opioid analgesic added in both grouos
Control Intervention1: Levobupivacaine: Local anesthetic agent. Levo rotatory isomer of bupivacaine
Control Intervention2: Bupivacaine: Local anesthetic agent
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Primary Outcome(s)
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Duration of sensory blockTimepoint: Time to complete recovery of sensory block assessed by pin prick
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Secondary Outcome(s)
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Duration of motor block
Timepoint: Time to reach Modified Bromage Score to zero.
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Source(s) of Monetary Support
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Sawai Man Singh Medical College and Hospital, Sawai Man Singh Road, Tonk Road, Jaipur, Rajasthan. 302001
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Ethics review
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Status: Approved
Approval date: 06/06/2015
Contact:
Ethics Committee,SMS Medical College and Hospital, Jaipur
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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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