ESP vs ESP With PECS

Postoperative Pain Clinical Trial

Official title:

Efficacy of Erector Spinae Plane Block and Pectoral Fascia Block in Patients Undergoing Mitral Valve Repair Through the Right Mini-thoracotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592485
• Other study ID #: KE-0254/127/2018
• Status: Completed
• Phase: Phase 4
• Start date: June 28, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: February 2019
• Source: Medical University of Lublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 30, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Mitral Valve Disease
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Erector 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: 0.1 mL per patients' KG. The maximum dose is 20 mL.
• Pectoral Fascia block
Before the beginning of the procedure, PECS type I and II blocks will be performed under ultrasound control. A single-shot technique will be used with 0.375 % solution of ropivacaine: 0.1 mL per patients' KG. The maximum dose is 20 mL.

Drug:
• Oxycodone
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.

Procedure:
• general anesthesia
Each patient will generally anesthetized and endotracheal tube will be inserted

Drug:
• paracetamol
Paracetamol will be given i.v. every 6 hours.

Locations

Country	Name	City	State
Poland	Division of Cardiovascular Surgery, St. Jadwiga Provincial Clinical Hospital, Rzeszów, Poland	Rzeszów

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Lublin	Division of Cardiovascular Surgery, St. Jadwiga Provincial Clinical Hospital, Rzeszów, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total consumption of oxycodone	The cumulative consumption of oxycodone during 24 hour from the end of anesthesia. Less is better, less intense pain.	From the end of anesthesia till 24 hour postoperatively
Secondary	Pain intensity measured by VAS	Patient self-pain assessment on VAS (visual-analogue scale). VAS range from 0 (no pain, good outcome) to 100 in millimeters (the worst pain ever, bad outcome)	From the end of anesthesia till 24 hour postoperatively