Postoperative Pain Management After Minimally Invasive Aortic Valve Surgery

NCT ID: NCT03079830

Last Updated: 2019-03-21

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-01-11

Brief Summary

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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. The patients will be enrolled in two different groups according to the protocol of the local anesthetic and saline administration:

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.

Detailed Description

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Patients undergoing minimally invasive aortic valve replacment surgery will be enroled in the study, after giving a signed informed consent.

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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Aortic Valve Surgery Postoperative; Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ropivacaine continous infusion

Piritramid

Group Type ACTIVE_COMPARATOR

Piritramid

Intervention Type DRUG

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

Group Type SHAM_COMPARATOR

Piritramid

Intervention Type DRUG

Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter.

Saline

Intervention Type DRUG

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.

Intervention Type DRUG

Saline

Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter.

Intervention Type DRUG

Other Intervention Names

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Dipidolor Saline Solution

Eligibility Criteria

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Inclusion Criteria

* Patients after minimally invasive aortic valve surgery
* Patients agreement with the study

Exclusion Criteria

* Age under 18 years
* Allergy to local anesthetic
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Maja Sostaric

asoc. prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Slovenia

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.

Reference Type DERIVED
PMID: 32682395 (View on PubMed)

Other Identifiers

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KVIT2016

Identifier Type: -

Identifier Source: org_study_id

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