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

University Medical Centre Ljubljana

Status: Completed

Conditions: Aortic Valve Surgery; Postoperative; Pain

Treatments: Drug: Piritramid; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03079830

KVIT2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients after minimally invasive aortic valve surgery
• Patients agreement with the study

Exclusion criteria

• Age under 18 years
• Allergy to local anesthetic

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

76 participants in 2 patient groups

Ropivacaine continous infusion

Active Comparator group

Description:

Piritramid

Treatment:

Drug: Piritramid

Saline continous

Sham Comparator group

Description:

Piritramid

Treatment:

Drug: Saline

Drug: Piritramid