Aortic Valve Surgery, Postoperative; Pain
Conditions
Keywords
aortic valve surgery, postoperative pain
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.
Interventions
DRUGPiritramid
Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter.
DRUGSaline
Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter.
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients after minimally invasive aortic valve surgery * Patients agreement with the study
Exclusion criteria
* Age under 18 years * Allergy to local anesthetic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Hospital lenght of stay | Up to 30 days | Hospital lenght of stay |
Countries
Slovenia
Outcome results
None listed