Clinical trial NCT03079830: Postoperative Pain Management After Minimally Invasive Aortic Valve Surgery
Official title: Efficacy of Ropivacaine Wound Infiltration for Postoperative Pain Management After Minimally Invasive Aortic Valve Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Surgery
Postoperative; Pain
Keywords: aortic valve surgery
postoperative pain
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Comparison of cumulative postoperative dose of Piritramid between the two different protocols, using VAS scale to determine level of analgesia.
timeFrame: 48 hours after admission to the intensive care unit (ICU)
Secondary outcomes:
measure: Complications related to the catheter in the surgical wound
timeFrame: Up to 30 days
measure: Visual analogue scale (VAS), frequency of scores higher than 3
timeFrame: 48 hours after admission to the ICU
measure: Patients satisfaction with pain relief measured by Likert-type Patient satisfaction scale
timeFrame: 72 hours after surgery
measure: Rate of complications related to the local anesthetic
timeFrame: 72 hours after surgery
measure: Hospital lenght of stay
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Clinical Center Ljubljana
Study officials:
affiliation: Clinical department of anesthesiology and intensive care
name: Maja Sostaric, PhD
role: STUDY_CHAIR
References:
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.