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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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8 August 2016 |
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Main ID: |
NCT02566096 |
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Date of registration:
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30/09/2015 |
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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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Efficacy of Transverses Abdominis -Plane Block With Bupivacaine Versus Bupivacaine With Morphine Postoperatively
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Scientific title:
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Efficacy of Transverses Abdominis -Plane Block With Bupivacaine Versus Bupivacaine With Morphine in Patients Undergoing Major Abdominal Cancer Surgery |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02566096 |
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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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
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Phase:
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Phase 4
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Countries of recruitment
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Egypt
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 60 ASA I-II cancer patients with age range (18-60) years,
- weight (50- 85) kg
Exclusion Criteria:
- with patients with known drug allergy to study drugs
- with significant cardiac, respiratory, renal or hepatic disease
- with coagulation disorders
- those with psychiatric illnesses that would interfere with perception and assessment
of pain.
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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Abdominal Cancer
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Intervention(s)
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Drug: transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine
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Primary Outcome(s)
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The presence and severity of pain at rest and on coughing will be assessed using a Visual Analog Scale
[Time Frame: first 24 hours postoperatively]
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Secondary Outcome(s)
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first request for analgesia in minutes will be observed
[Time Frame: firsr 24 hours]
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the level of sedation by using sedation score
[Time Frame: 24 hours postoperatively]
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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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