Postoperative Pain Management After Minimally Invasive Aortic Valve Surgery

Not Applicable

Completed

• Conditions: Aortic Valve Surgery; Postoperative; Pain
• Interventions: Drug: Piritramid; Drug: Saline

• Registration Number: NCT03079830
• Lead Sponsor: University Medical Centre Ljubljana

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. 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.

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 Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2017-03-08
• Study First Posted: 2017-03-15
• Primary Completion: 2017-12-31
• Study Completion: 2018-01-11
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline continous	Piritramid	Piritramid
Saline continous	Saline	Piritramid
Ropivacaine continous infusion	Piritramid	Piritramid

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Hospital lenght of stay	Up to 30 days	Hospital lenght of stay
Patients satisfaction with pain relief measured by Likert-type Patient satisfaction scale	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
Rate of complications related to the local anesthetic	72 hours after surgery	Neurotoxicity and cardiotoxicity related to the local anesthetic
Complications related to the catheter in the surgical wound	Up to 30 days	Complications related to the catheter in the surgical wound
Visual analogue scale (VAS), frequency of scores higher than 3	48 hours after admission to the ICU	Visual analogue scale (VAS), frequency of scores higher than 3

Trial Locations

Locations (1)

University Clinical Center Ljubljana; 🇸🇮 Ljubljana, Slovenia