ESP vs ESP With PECS

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03592485

Enrollment

Registered

2018-07-19

Start date

2018-06-28

Completion date

2018-09-30

Last updated

2019-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Disease, Postoperative Pain

Keywords

Erector Spinae Plane blockade, Pectoral Fascia block, patient control anlagesia, mitral valve replacement

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.

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: 0.1 mL per patients' KG. The maximum dose is 20 mL.

PROCEDUREPectoral 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.

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.

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

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)

Design outcomes

Primary

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. Less is better, less intense pain.

Secondary

Measure	Time frame	Description
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)

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026