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Completed

NCT Number: NCT03079830

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.

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Key information

Conditions

Aortic Valve Surgery Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative; Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinical Center Ljubljana

Ljubljana, 1000, Slovenia

About this study

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:

  • group: continous infusion of the local anesthetic plus bolus on demand
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age under 18 years
  • Allergy to local anesthetic

Treatment and study plan

Piritramid

Drug

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

Saline

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Complications related to the catheter in the surgical wound

    Time frame: Up to 30 days

    Complications related to the catheter in the surgical wound

  2. 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

  3. 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

  4. Rate of complications related to the local anesthetic

    Time frame: 72 hours after surgery

    Neurotoxicity and cardiotoxicity related to the local anesthetic

  5. Hospital lenght of stay

    Time frame: Up to 30 days

    Hospital lenght of stay

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Acronym: PPMAMIAVS

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 15, 2017
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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