Postoperative Pain Management After Minimally Invasive Aortic Valve Surgery

Study Overview
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Brief Summary
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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: group: continous infusion of the local anesthetic plus bolus on demand group: continous infusion of saline plus bolus on demand For all patients metamizol every 12 hours plus bolous of piritramid on demand.

Detailed Description
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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: group: continous infusion of the local anesthetic plus bolus on demand 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.

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

Conditions
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Aortic Valve Surgery, Postoperative; Pain

Intervention / Treatment
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* Drug: Piritramid
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients after minimally invasive aortic valve surgery Patients agreement with the study Exclusion Criteria: Age under 18 years Allergy to local anesthetic

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ropivacaine continous infusion<br>Piritramid | Drug: Piritramid<br>* Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter.<br>* Other names: Dipidolor;|
| Sham Comparator: Saline continous<br>Piritramid | Drug: Piritramid<br>* Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter.<br>* Other names: Dipidolor;Drug: Saline<br>* Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter.<br>* Other names: Saline Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic valve surgery, postoperative pain