Postoperative Analgesia After Minithoracotomy

Study Overview
=================
Brief Summary
-----------------
Patients scheduled for minimally invasive mitral valve replacement. Each patient will be treated with intravenous (i.v.) oxycodone - patient-controlled analgesia (PCA). Half of the patients will be randomly allocated to Erector Spinae Plane (ESP) blockade group.

Detailed Description
-----------------
Only patients who are qualified for an elective procedure of mitral valve replacement may participate in the study. Each patient will be anesthetized generally. The same drugs will be used in each stage of anesthesia. The induction: etomidate, remifentanil, rocuronium, scolina as required. The maintenance: sevoflurane, remifentanil, rocuronium. The emergence: oxygen, sugammadex or neostigmine a required. Patients will be randomly allocated into one of two groups: PCA or ESP. Among the patients from ESP group will have ESP blockade before the induction of general anesthesia. ESP blockade will be performed under ultrasound control. A single-shot technique will be used with 0.375 % solution of ropivacaine: 0.2 mL per patients' KG. The maximum dose is 40 mL. Each patient, before the end of surgery, will be administered i.v. 0.1 mg of oxycodone. PCA with oxycodone (1mg/mL) will be utilized during the postoperative period: 5-minute interval. This is standard protocol in our department. Only patients who are successfully awakened after the procedure may participate in the study. The pain intensity will be assessed with visual-analogue scale (VAS) at 2, 4, 8, 12 and 24 hour after the end of anesthesia. The total consumption of oxycodone will be also monitored.

Official Title
-----------------
Efficacy of Erector Spinae Plane (ESP) Blockade in Patients Scheduled for Minimally Invasively Mitral Valve Replacement

Conditions
-----------------
Postoperative Pain, Mitral Valve Disease

Intervention / Treatment
-----------------
* Procedure: Erector Spinae Plane blockade
* Drug: Oxycodone
* Procedure: general anesthesia
* Drug: paracetamol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled mitral valve replacement surgery obtained consent Exclusion Criteria: allergy to oxycodone and local anesthetics depression, antidepressant drugs treatment epilepsy usage of painkiller before surgery addiction to alcohol or recreational drugs postoperative ventilation or ICU admission

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESP<br>Before the induction of general anesthesia, Erector Spinae Plane (ESP) blockade will be done. Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose. | Procedure: Erector Spinae Plane blockade<br>* Before the beginning of the procedure, ESP blockade will be performed under ultrasound control. A single-shot technique will be used with 0.375 % solution of ropivacaine: 0.2 mL per patients' KG. The maximum dose is 40 mL.<br>* Other names: ESP;Drug: Oxycodone<br>* Each patient, before the end of surgery, will be administered i.v. 0.1 mg of oxycodone. PCA with oxycodone (1mg/mL) will be utilized during the postoperative period: 5-minute interval.<br>* Other names: PCA with oxycodone;Procedure: general anesthesia<br>* Each patient will generally anesthetized and endotracheal tube will be inserted<br>* Other names: GA;Drug: paracetamol<br>* Paracetamol will be given i.v. every 6 hours.<br>|
| Experimental: PCA<br>Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose. ESP will not be done in this arm. | Drug: Oxycodone<br>* Each patient, before the end of surgery, will be administered i.v. 0.1 mg of oxycodone. PCA with oxycodone (1mg/mL) will be utilized during the postoperative period: 5-minute interval.<br>* Other names: PCA with oxycodone;Procedure: general anesthesia<br>* Each patient will generally anesthetized and endotracheal tube will be inserted<br>* Other names: GA;Drug: paracetamol<br>* Paracetamol will be given i.v. every 6 hours.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Patients' self-pain assessment with VAS (visual-analogue scale) | From the end of anesthesia till 24 hour postoperatively. VAS range from 0 (no pain, good outcome) to 100 in millimeters (the worst pain ever, bad outcome). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total consumption of oxycodone | The cumulative consumption of oxycodone during 24 hour from the end of anesthesia. | From the end of anesthesia till 24 hour postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erector Spinae Plane blockade, patient control anlagesia, mitral valve replacement