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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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19 February 2015 |
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Main ID: |
NCT02198027 |
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Date of registration:
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21/07/2014 |
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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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Peritubal Infiltration of Bupivacaine in PCNL
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Scientific title:
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Role of Peritubal Infiltration of 0.25% Bupivacaine in Percutaneous Nephrolithotomy (PCNL) in Postoperative Pain Control |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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68 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02198027 |
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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, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Zeeshan Arshad, MBBS |
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Address:
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Telephone:
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Email:
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zeeshandaa@hotmail.com |
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Affiliation:
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Name:
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Naila Baig-Ansari, PhD |
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Address:
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Telephone:
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Email:
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naila.baig.ansari@gmail.com |
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Affiliation:
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Name:
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Zafar Zaidi, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Indus Hospital |
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Name:
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Zeeshan Arshad, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Indus Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 18-60 years of age
- Single PCNL track
Exclusion Criteria:
- Spinal Disc Prolapse
- Any previous renal surgery
- Complication secondary to PCNL
- Hydrothorax that requires intervention
- Pneumothorax
- Massive hemorrhage that requires more than 1 U transfusion
- Conversion to open procedure.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pain
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Intervention(s)
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Drug: Bupivacaine
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Other: Normal saline infiltration
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Primary Outcome(s)
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Mean time for first demand of rescue analgesic
[Time Frame: Release of the patient from the hospital or 24 hours (whichever comes first)]
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Secondary ID(s)
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IRD_IRB_2014_01_002
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TIH-Urology-001
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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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