NCT03079830

Brief Summary

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. 1.group: continous infusion of the local anesthetic plus bolus on demand
  2. 2.group: continous infusion of saline plus bolus on demand For all patients metamizol every 12 hours plus bolous of piritramid on demand.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2018

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

1.2 years

First QC Date

October 11, 2016

Last Update Submit

March 19, 2019

Conditions

Aortic Valve SurgeryPostoperative; Pain

Keywords

aortic valve surgerypostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Comparison of cumulative postoperative dose of Piritramid between the two different protocols, using VAS scale to determine level of analgesia.

    Comparison of cumulative postoperative dose of Piritramid between the two protocols

    48 hours after admission to the intensive care unit (ICU)

Secondary Outcomes (5)

  • Complications related to the catheter in the surgical wound

    Up to 30 days

  • 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

    72 hours after surgery

  • Rate of complications related to the local anesthetic

    72 hours after surgery

  • Hospital lenght of stay

    Up to 30 days

Study Arms (2)

Ropivacaine continous infusion

ACTIVE COMPARATOR

Piritramid

Drug: Piritramid

Saline continous

SHAM COMPARATOR

Piritramid

Drug: PiritramidDrug: Saline

Interventions

PiritramidDRUG

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

Also known as: Dipidolor
Ropivacaine continous infusionSaline continous
SalineDRUG

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

Also known as: Saline Solution
Saline continous

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age under 18 years
  • Allergy to local anesthetic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinical Center Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

  • 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.

    PMID: 32682395DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

PirinitramideSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Isonipecotic AcidsAcids, HeterocyclicHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-RingChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Maja Sostaric, PhD

    Clinical department of anesthesiology and intensive care

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
asoc. prof.

Study Record Dates

First Submitted

October 11, 2016

First Posted

March 15, 2017

Study Start

October 1, 2016

Primary Completion

December 31, 2017

Study Completion

January 11, 2018

Last Updated

March 21, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)