search
Back to results

ESP vs ESP With PECS

Primary Purpose

Postoperative Pain, Mitral Valve Disease

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Erector Spinae Plane blockade
Pectoral Fascia block
Oxycodone
general anesthesia
paracetamol
Sponsored by
Medical University of Lublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Erector Spinae Plane blockade, Pectoral Fascia block, patient control anlagesia, mitral valve replacement

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ESP

PECS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Total consumption of oxycodone
The cumulative consumption of oxycodone during 24 hour from the end of anesthesia. Less is better, less intense pain.

Secondary Outcome Measures

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)

Full Information

First Posted
July 5, 2018
Last Updated
February 27, 2019
Sponsor
Medical University of Lublin
Collaborators
Division of Cardiovascular Surgery, St. Jadwiga Provincial Clinical Hospital, Rzeszów, Poland
search

1. Study Identification

Unique Protocol Identification Number
NCT03592485
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 28, 2018 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Lublin
Collaborators
Division of Cardiovascular Surgery, St. Jadwiga Provincial Clinical Hospital, Rzeszów, Poland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Mitral Valve Disease
Keywords
Erector Spinae Plane blockade, Pectoral Fascia block, patient control anlagesia, mitral valve replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Participant
Masking Description
Single (Participant)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESP
Arm Type
Experimental
Arm Description
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.
Arm Title
PECS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane blockade
Intervention Description
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
Intervention Name(s)
Pectoral Fascia block
Intervention Description
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
Drug
Intervention Name(s)
Oxycodone
Intervention Description
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
Procedure
Intervention Name(s)
general anesthesia
Other Intervention Name(s)
GA
Intervention Description
Each patient will generally anesthetized and endotracheal tube will be inserted
Intervention Type
Drug
Intervention Name(s)
paracetamol
Intervention Description
Paracetamol will be given i.v. every 6 hours.
Primary Outcome Measure Information:
Title
Total consumption of oxycodone
Description
The cumulative consumption of oxycodone during 24 hour from the end of anesthesia. Less is better, less intense pain.
Time Frame
From the end of anesthesia till 24 hour postoperatively
Secondary Outcome Measure Information:
Title
Pain intensity measured by VAS
Description
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)
Time Frame
From the end of anesthesia till 24 hour postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Division of Cardiovascular Surgery, St. Jadwiga Provincial Clinical Hospital, Rzeszów, Poland
City
Rzeszów
ZIP/Postal Code
35-501
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32106812
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.
Results Reference
derived

Learn more about this trial

ESP vs ESP With PECS

We'll reach out to this number within 24 hrs