Postoperative Pain Management After Minimally Invasive Aortic Valve Surgery (PPMAMIAVS)
Primary Purpose
Aortic Valve Surgery, Postoperative; Pain
Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Piritramid
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Surgery focused on measuring aortic valve surgery, postoperative pain
Eligibility Criteria
Inclusion Criteria:
- Patients after minimally invasive aortic valve surgery
- Patients agreement with the study
Exclusion Criteria:
- Age under 18 years
- Allergy to local anesthetic
Sites / Locations
- University Clinical Center Ljubljana
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Ropivacaine continous infusion
Saline continous
Arm Description
Piritramid
Piritramid
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Complications related to the catheter in the surgical wound
Complications related to the catheter in the surgical wound
Visual analogue scale (VAS), frequency of scores higher than 3
Visual analogue scale (VAS), frequency of scores higher than 3
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
Rate of complications related to the local anesthetic
Neurotoxicity and cardiotoxicity related to the local anesthetic
Hospital lenght of stay
Hospital lenght of stay
Full Information
NCT ID
NCT03079830
First Posted
October 11, 2016
Last Updated
March 19, 2019
Sponsor
University Medical Centre Ljubljana
1. Study Identification
Unique Protocol Identification Number
NCT03079830
Brief Title
Postoperative Pain Management After Minimally Invasive Aortic Valve Surgery
Acronym
PPMAMIAVS
Official Title
Efficacy of Ropivacaine Wound Infiltration for Postoperative Pain Management After Minimally Invasive Aortic Valve Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
January 11, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
group: continous infusion of the local anesthetic plus bolus on demand
group: continous infusion of saline plus bolus on demand For all patients metamizol every 12 hours plus bolous of piritramid on demand.
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Surgery, Postoperative; Pain
Keywords
aortic valve surgery, postoperative pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ropivacaine continous infusion
Arm Type
Active Comparator
Arm Description
Piritramid
Arm Title
Saline continous
Arm Type
Sham Comparator
Arm Description
Piritramid
Intervention Type
Drug
Intervention Name(s)
Piritramid
Other Intervention Name(s)
Dipidolor
Intervention Description
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
Intervention Name(s)
Saline
Other Intervention Name(s)
Saline Solution
Intervention Description
Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter.
Primary Outcome Measure Information:
Title
Comparison of cumulative postoperative dose of Piritramid between the two different protocols, using VAS scale to determine level of analgesia.
Description
Comparison of cumulative postoperative dose of Piritramid between the two protocols
Time Frame
48 hours after admission to the intensive care unit (ICU)
Secondary Outcome Measure Information:
Title
Complications related to the catheter in the surgical wound
Description
Complications related to the catheter in the surgical wound
Time Frame
Up to 30 days
Title
Visual analogue scale (VAS), frequency of scores higher than 3
Description
Visual analogue scale (VAS), frequency of scores higher than 3
Time Frame
48 hours after admission to the ICU
Title
Patients satisfaction with pain relief measured by Likert-type Patient satisfaction scale
Description
Patients satisfaction regarding pain relief, in the following order 1.very satisfied 2.satisfied 3.neither satisfied nor dissatisfied 4.dissatisfied 5.completely dissatisfied
Time Frame
72 hours after surgery
Title
Rate of complications related to the local anesthetic
Description
Neurotoxicity and cardiotoxicity related to the local anesthetic
Time Frame
72 hours after surgery
Title
Hospital lenght of stay
Description
Hospital lenght of stay
Time Frame
Up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients after minimally invasive aortic valve surgery
Patients agreement with the study
Exclusion Criteria:
Age under 18 years
Allergy to local anesthetic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maja Sostaric, PhD
Organizational Affiliation
Clinical department of anesthesiology and intensive care
Official's Role
Study Chair
Facility Information:
Facility Name
University Clinical Center Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32682395
Citation
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.
Results Reference
derived
Learn more about this trial
Postoperative Pain Management After Minimally Invasive Aortic Valve Surgery
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