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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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12 December 2020 |
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Main ID: |
NCT03074097 |
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Date of registration:
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27/02/2017 |
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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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Rectus Sheath Block: Postoperative Analgesia and Proinflammatory Cytokines
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Scientific title:
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Effect of Rectus Sheath Block on Opioid Consumption and Serum Level of TNF-a and IL-6 After Radical Prostatectomy |
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Date of first enrolment:
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March 5, 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/NCT03074097 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Care Provider).
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Phase:
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Phase 2
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Waleed S Farrag |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assiut University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Male patients their age over 40 years, classified ASA I, II or III, undergoing radical
resection of cancer prostate, through midline abdominal incision under general anaesthesia.
Exclusion criteria:
Contraindications to rectus sheath block as patient refusal, coagulopathy, local infection
and allergy to bupivacaine. Planned transverse or oblique abdominal incision, extensive
existing midline abdominal scarring or pre-existing chronic abdominal pain.
Age minimum:
40 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Postoperative Pain
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Intervention(s)
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Drug: Bupivacaine 0.25%
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Primary Outcome(s)
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cumulative opioid consumption
[Time Frame: 24 hours postoperative]
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Secondary Outcome(s)
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Numerical rating scale (NRS)
[Time Frame: 24 hours postoperative]
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serum levels of TNF-a
[Time Frame: at 24 hours postoperative]
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time to first anlgesic request
[Time Frame: 24 hours postoperative]
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Serum level of IL-6
[Time Frame: at 24 hours postoperative]
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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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