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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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4 December 2023 |
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Main ID: |
NCT03415555 |
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Date of registration:
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23/01/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Postoperative Analgesia After Minithoracotomy
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Scientific title:
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Efficacy of Erector Spinae Plane (ESP) Blockade in Patients Scheduled for Minimally Invasively Mitral Valve Replacement |
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Date of first enrolment:
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February 7, 2018 |
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Target sample size:
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19 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03415555 |
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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: Treatment. Masking: Single (Participant).
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Phase:
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Phase 4
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Countries of recruitment
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Poland
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Contacts
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Name:
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Miroslaw Czuczwar, M.D., PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical University of Lublin |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Scheduled mitral valve replacement surgery
- obtained consent
Exclusion Criteria:
- allergy to oxycodone and local anesthetics
- depression, antidepressant drugs treatment
- epilepsy
- usage of painkiller before surgery
- addiction to alcohol or recreational drugs
- postoperative ventilation or ICU admission
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Mitral Valve Disease
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Postoperative Pain
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Intervention(s)
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Procedure: general anesthesia
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Drug: paracetamol
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Drug: Oxycodone
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Procedure: Erector Spinae Plane blockade
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Primary Outcome(s)
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Pain intensity
[Time Frame: From the end of anesthesia till 24 hour postoperatively. VAS range from 0 (no pain, good outcome) to 100 in millimeters (the worst pain ever, bad outcome).]
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Secondary Outcome(s)
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Total consumption of oxycodone
[Time Frame: From the end of anesthesia till 24 hour postoperatively]
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Secondary ID(s)
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KE-0254/26/2018
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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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