Postoperative Pain Management After Minimally Invasive Aortic Valve Surgery (PPMAMIAVS)

March 19, 2019 updated by: Maja Sostaric, University Medical Centre Ljubljana

Efficacy of Ropivacaine Wound Infiltration for Postoperative Pain Management After Minimally Invasive Aortic Valve Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Clinical Center Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Age under 18 years
  • Allergy to local anesthetic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ropivacaine continous infusion
Piritramid
Drug: Piritramid
Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter.
Other Names:
  • Dipidolor
Sham Comparator: Saline continous
Piritramid
Drug: Piritramid
Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter.
Other Names:
  • Dipidolor
Drug: Saline
Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter.
Other Names:
  • Saline Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of cumulative postoperative dose of Piritramid between the two different protocols, using VAS scale to determine level of analgesia.
Time Frame: 48 hours after admission to the intensive care unit (ICU)
Comparison of cumulative postoperative dose of Piritramid between the two protocols
48 hours after admission to the intensive care unit (ICU)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications related to the catheter in the surgical wound
Time Frame: Up to 30 days
Complications related to the catheter in the surgical wound
Up to 30 days
Visual analogue scale (VAS), frequency of scores higher than 3
Time Frame: 48 hours after admission to the ICU
Visual analogue scale (VAS), frequency of scores higher than 3
48 hours after admission to the ICU
Patients satisfaction with pain relief measured by Likert-type Patient satisfaction scale
Time Frame: 72 hours after surgery
Patients satisfaction regarding pain relief, in the following order 1.very satisfied 2.satisfied 3.neither satisfied nor dissatisfied 4.dissatisfied 5.completely dissatisfied
72 hours after surgery
Rate of complications related to the local anesthetic
Time Frame: 72 hours after surgery
Neurotoxicity and cardiotoxicity related to the local anesthetic
72 hours after surgery
Hospital lenght of stay
Time Frame: Up to 30 days
Hospital lenght of stay
Up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Investigators

  • Study Chair: Maja Sostaric, PhD, Clinical department of anesthesiology and intensive care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

January 11, 2018

Study Registration Dates

First Submitted

October 11, 2016

First Submitted That Met QC Criteria

March 8, 2017

First Posted (Actual)

March 15, 2017

Study Record Updates

Last Update Posted (Actual)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KVIT2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe