Mitral Valve Disease, Postoperative Pain
Conditions
Keywords
Erector Spinae Plane blockade, patient control anlagesia, mitral valve replacement
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.
Interventions
PROCEDUREErector Spinae Plane blockade
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.
DRUGOxycodone
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.
PROCEDUREgeneral anesthesia
Each patient will generally anesthetized and endotracheal tube will be inserted
DRUGparacetamol
Paracetamol will be given i.v. every 6 hours.
Sponsors
University of Rzeszow
Medical University of Lublin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single (Participant)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 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). | Patients' self-pain assessment with VAS (visual-analogue scale) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total consumption of oxycodone | From the end of anesthesia till 24 hour postoperatively | The cumulative consumption of oxycodone during 24 hour from the end of anesthesia. |
Countries
Poland
Outcome results
None listed