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Postoperative Analgesia After Minithoracotomy

Primary Purpose

Postoperative Pain, Mitral Valve Disease

Status
Unknown status
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Erector Spinae Plane blockade
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, 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
  • postoperative ventilation or ICU admission

Sites / Locations

  • Queen Jadwiga HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ESP

PCA

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.

Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose. ESP will not be done in this arm.

Outcomes

Primary Outcome Measures

Pain intensity
Patients' self-pain assessment with VAS (visual-analogue scale)

Secondary Outcome Measures

Total consumption of oxycodone
The cumulative consumption of oxycodone during 24 hour from the end of anesthesia.

Full Information

First Posted
January 23, 2018
Last Updated
March 21, 2018
Sponsor
Medical University of Lublin
Collaborators
Medical University of Rzeszów
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1. Study Identification

Unique Protocol Identification Number
NCT03415555
Brief Title
Postoperative Analgesia After Minithoracotomy
Official Title
Efficacy of Erector Spinae Plane (ESP) Blockade in Patients Scheduled for Minimally Invasively Mitral Valve Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
May 7, 2018 (Anticipated)
Study Completion Date
June 4, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Lublin
Collaborators
Medical University of Rzeszów

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 replacement. Each patient will be treated with intravenous (i.v.) oxycodone - patient-controlled analgesia (PCA). Half of the patients will be randomly allocated to Erector Spinae Plane (ESP) blockade group.
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 into one of two groups: PCA or ESP. 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: 0.2 mL per patients' KG. The maximum dose is 40 mL. 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. This is standard protocol in our 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, 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
20 (Anticipated)

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
PCA
Arm Type
Experimental
Arm Description
Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose. ESP will not be done in this arm.
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane blockade
Other Intervention Name(s)
ESP
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: 0.2 mL per patients' KG. The maximum dose is 40 mL.
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Other Intervention Name(s)
PCA with 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
Pain intensity
Description
Patients' self-pain assessment with VAS (visual-analogue scale)
Time Frame
From the end of anesthesia till 24 hour postoperatively. VAS range from 0 (no pain, good outcome) to 100 in millimeters (the worst pain ever, bad outcome).
Secondary Outcome Measure Information:
Title
Total consumption of oxycodone
Description
The cumulative consumption of oxycodone during 24 hour from the end of anesthesia.
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 postoperative ventilation or ICU admission
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michał Borys, M.D., PhD
Phone
506350569
Email
michalborys1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirosław Czuczwar, M.D., PhD
Organizational Affiliation
Medical University of Lublin
Official's Role
Study Chair
Facility Information:
Facility Name
Queen Jadwiga Hospital
City
Rzeszów
ZIP/Postal Code
35-501
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beata Horeczy, M.D.
Phone
+48 784445414
Email
beata.horeczy@yahoo.com

12. IPD Sharing Statement

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Postoperative Analgesia After Minithoracotomy

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