Postoperative Pain Management After Minimally Invasive Aortic Valve Surgery

Aortic Valve Surgery Clinical Trial

— PPMAMIAVS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03079830
• Other study ID #: KVIT2016
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: January 11, 2018

Study information

• Verified date: March 2019
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 11, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients after minimally invasive aortic valve surgery

• Patients agreement with the study

Exclusion Criteria:

• Age under 18 years

• Allergy to local anesthetic

Related Conditions & MeSH terms

• Aortic Valve Surgery
• Pain, Postoperative
• Postoperative; Pain

Intervention

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

Locations

Country	Name	City	State
Slovenia	University Clinical Center Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complications related to the catheter in the surgical wound	Complications related to the catheter in the surgical wound	Up to 30 days
Secondary	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
Secondary	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
Secondary	Rate of complications related to the local anesthetic	Neurotoxicity and cardiotoxicity related to the local anesthetic	72 hours after surgery
Secondary	Hospital lenght of stay	Hospital lenght of stay	Up to 30 days