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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine continous infusion | Active Comparator | Piritramid |
|
| Saline continous | Sham Comparator | Piritramid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Piritramid | Drug | Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Complications related to the catheter in the surgical wound | Complications related to the catheter in the surgical wound | Up to 30 days |
| Visual analogue scale (VAS), frequency of scores higher than 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maja Sostaric, PhD | Clinical department of anesthesiology and intensive care | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinical Center Ljubljana | Ljubljana | 1000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32682395 | Derived | 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D010892 | Pirinitramide |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007540 | Isonipecotic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
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|
| Saline | Drug | Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter. |
|
|
Visual analogue scale (VAS), frequency of scores higher than 3
| 48 hours after admission to the ICU |
| 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 |
| Rate of complications related to the local anesthetic | Neurotoxicity and cardiotoxicity related to the local anesthetic | 72 hours after surgery |
| Hospital lenght of stay | Hospital lenght of stay | Up to 30 days |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |