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

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: Aortic Valve Surgery; Postoperative; Pain
• Intervention / Treatment: Drug: Piritramid; Drug: Saline

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	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	Complications related to the catheter in the surgical wound	Up to 30 days
Visual analogue scale (VAS), frequency of scores higher than 3	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	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	Neurotoxicity and cardiotoxicity related to the local anesthetic	72 hours after surgery
Hospital lenght of stay	Hospital lenght of stay	Up to 30 days

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Investigators: Study Chair: Maja Sostaric, PhD, Clinical department of anesthesiology and intensive care

Publications and helpful links

General Publications

• 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.

Study record dates

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: postoperative pain; aortic valve surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Pirinitramide
• Other Study ID Numbers: KVIT2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO