Postoperative Pain Management After Minimally Invasive Aortic Valve Surgery
NCT ID: NCT03079830
Last Updated: 2019-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
76 participants
INTERVENTIONAL
2016-10-31
2018-01-11
Brief Summary
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1. group: continous infusion of the local anesthetic plus bolus on demand
2. group: continous infusion of saline plus bolus on demand For all patients metamizol every 12 hours plus bolous of piritramid on demand.
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Detailed Description
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The study evaluates the efficacy of local anesthestic application through the catheter in the surgical wound for the postoperative pain relief after minimally invasive aortic valve surgery.
Patients will then be randomised in two groups according to the protocol:
1. group: continous infusion of the local anesthetic plus bolus on demand
2. group: continous infusion of saline plus bolus on demand
All patients will receive Metamizol every 12 hours plus bolus of piritramid on demand.
Analgesia effectivness will be checked hourly according to the visual analogue scale (VAS). According to protocol, bolus will be given every time the score of VAS scale is \>3.
The catheter will be removed 48 hours after the protocols' start.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ropivacaine continous infusion
Piritramid
Piritramid
Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter.
Saline continous
Piritramid
Piritramid
Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter.
Saline
Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter.
Interventions
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Piritramid
Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter.
Saline
Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients agreement with the study
Exclusion Criteria
* Allergy to local anesthetic
18 Years
ALL
No
Sponsors
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University Medical Centre Ljubljana
OTHER
Responsible Party
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Maja Sostaric
asoc. prof.
Principal Investigators
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Maja Sostaric, PhD
Role: STUDY_CHAIR
Clinical department of anesthesiology and intensive care
Locations
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University Clinical Center Ljubljana
Ljubljana, , Slovenia
Countries
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References
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Mijovski G, Podbregar M, Ksela J, Jenko M, Sostaric M. Effectiveness of wound infusion of 0.2% ropivacaine by patient control analgesia pump after minithoracotomy aortic valve replacement: a randomized, double-blind, placebo-controlled trial. BMC Anesthesiol. 2020 Jul 18;20(1):172. doi: 10.1186/s12871-020-01093-9.
Other Identifiers
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KVIT2016
Identifier Type: -
Identifier Source: org_study_id
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