ESP vs ESP With PECS

NCT ID: NCT03592485

Last Updated: 2019-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-28
• Study Completion Date: 2018-09-30

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.

Conditions

Postoperative Pain; Mitral Valve Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ESP

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.

Group Type: EXPERIMENTAL

Erector Spinae Plane blockade

Intervention Type: PROCEDURE

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.

Oxycodone

Intervention Type: DRUG

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.

general anesthesia

Intervention Type: PROCEDURE

Each patient will generally anesthetized and endotracheal tube will be inserted

paracetamol

Intervention Type: DRUG

Paracetamol will be given i.v. every 6 hours.

PECS

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.

Group Type: EXPERIMENTAL

Erector Spinae Plane blockade

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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.

Oxycodone

Intervention Type: DRUG

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.

general anesthesia

Intervention Type: PROCEDURE

Each patient will generally anesthetized and endotracheal tube will be inserted

paracetamol

Intervention Type: DRUG

Paracetamol will be given i.v. every 6 hours.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

general anesthesia

Each patient will generally anesthetized and endotracheal tube will be inserted

Intervention Type: PROCEDURE

paracetamol

Paracetamol will be given i.v. every 6 hours.

Intervention Type: DRUG

Other Intervention Names

GA

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

Medical University of Lublin

OTHER

Sponsor Role: lead

Responsible Party

Michał Borys

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Rzeszów, , Poland

Countries

Poland

References

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.

Reference Type: DERIVED

PMID: 32106812 (View on PubMed)

Other Identifiers

KE-0254/127/2018

Identifier Type: -

Identifier Source: org_study_id