ESP vs ESP With PECS

Phase 4

Completed

• Conditions: Postoperative Pain; Mitral Valve Disease
• Interventions: Procedure: Erector Spinae Plane blockade; Procedure: Pectoral Fascia block; Drug: Oxycodone; Procedure: general anesthesia; Drug: paracetamol

• Registration Number: NCT03592485
• Lead Sponsor: Medical University of Lublin

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.

Study Timeline

• Study Start: 2018-06-28
• Study First Submitted: 2018-07-05
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-19
• Primary Completion: 2018-08-31
• Study Completion: 2018-09-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESP	general anesthesia	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.
PECS	Erector Spinae Plane blockade	Before the induction of general anesthesia, Erector Spinae Plane (ESP) block and Pectoral fascia type I and II will be done. Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose.
PECS	general anesthesia	Before the induction of general anesthesia, Erector Spinae Plane (ESP) block and Pectoral fascia type I and II will be done. Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose.
ESP	Erector Spinae Plane blockade	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.
PECS	Pectoral Fascia block	Before the induction of general anesthesia, Erector Spinae Plane (ESP) block and Pectoral fascia type I and II will be done. Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose.
ESP	Oxycodone	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.
ESP	paracetamol	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.
PECS	Oxycodone	Before the induction of general anesthesia, Erector Spinae Plane (ESP) block and Pectoral fascia type I and II will be done. Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose.
PECS	paracetamol	Before the induction of general anesthesia, Erector Spinae Plane (ESP) block and Pectoral fascia type I and II will be done. Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose.

Primary Outcome Measures

Name	Time	Method
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. Less is better, less intense pain.

Secondary Outcome Measures

Name	Time	Method
Pain intensity measured by VAS	From the end of anesthesia till 24 hour postoperatively	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)

Trial Locations

Locations (1)

Division of Cardiovascular Surgery, St. Jadwiga Provincial Clinical Hospital, Rzeszów, Poland; 🇵🇱 Rzeszów, Poland