Clinical trial NCT03592485: ESP vs ESP With PECS
Official title: Efficacy of Erector Spinae Plane Block and Pectoral Fascia Block in Patients Undergoing Mitral Valve Repair Through the Right Mini-thoracotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Mitral Valve Disease
Keywords: Erector Spinae Plane blockade
Pectoral Fascia block
patient control anlagesia
mitral valve replacement
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
Collaborators: name: Division of Cardiovascular Surgery, St. Jadwiga Provincial Clinical Hospital, Rzeszów, Poland
First posted: 2018-07-19
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: Patients scheduled for minimally invasive mitral valve repair. Each patient will be treated with intravenous (i.v.) oxycodone - patient-controlled analgesia (PCA). Patients will be allocated to one of the groups: erector spinae plane (ESP) block or EPS with pectoral fascia (PECS) block.

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 to one of two groups: ESP or PECS. 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: 0.1 mL per patient KG. The maximum dose is 20 mL.

Patients from PECS group will receive ESP block and PECS I and II type block with 0.375 % solution of ropivacaine (up to 20 mL of local anesthetic).

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: 7-minute interval. This is standard protocol in the investigator's 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.

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
* prolonged postoperative ventilation (over 2 hours)

Primary outcomes:
measure: Total consumption of oxycodone
timeFrame: From the end of anesthesia till 24 hour postoperatively
Secondary outcomes:
measure: Pain intensity measured by VAS
timeFrame: From the end of anesthesia till 24 hour postoperatively
Other outcomes:
Locations:
city: Rzeszów
country: Poland
facility: Division of Cardiovascular Surgery, St. Jadwiga Provincial Clinical Hospital, Rzeszów, Poland
Study officials:
References:
citation: Gaweda B, Borys M, Belina B, Bak J, Czuczwar M, Woloszczuk-Gebicka B, Kolowca M, Widenka K. Postoperative pain treatment with erector spinae plane block and pectoralis nerve blocks in patients undergoing mitral/tricuspid valve repair - a randomized controlled trial. BMC Anesthesiol. 2020 Feb 27;20(1):51. doi: 10.1186/s12871-020-00961-8.