ESP vs ESP With PECS

NCT03592485 | Completed Phase 4

• 1 other identifier: KE-0254/127/2018
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Mitral Valve Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Total consumption of oxycodone

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

  From the end of anesthesia till 24 hour postoperatively

Secondary Outcomes (1)

• Pain intensity measured by VAS

  From the end of anesthesia till 24 hour postoperatively

Study Arms (2)

ESP

EXPERIMENTAL

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.

Procedure: Erector Spinae Plane blockade; Drug: Oxycodone; Procedure: general anesthesia; Drug: paracetamol

PECS

EXPERIMENTAL

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.

Procedure: Erector Spinae Plane blockade; Procedure: Pectoral Fascia block; Drug: Oxycodone; Procedure: general anesthesia; Drug: paracetamol

Interventions

Erector Spinae Plane blockade 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.

ESP; PECS

Pectoral Fascia block 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.

PECS

Oxycodone 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.

ESP; PECS

general anesthesia PROCEDURE

Each patient will generally anesthetized and endotracheal tube will be inserted

Also known as: GA

ESP; PECS

paracetamol DRUG

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

ESP; PECS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled mitral valve replacement surgery
• obtained consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Lublin: lead
• Division of Cardiovascular Surgery, St. Jadwiga Provincial Clinical Hospital, Rzeszów, Poland: collaborator

Study Sites (1)

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

Rzeszów, 35-501, Poland

Location

Related Publications (1)

• 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.

  PMID: 32106812 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Oxycodone; Anesthesia, General; Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anesthesia; Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: July 19, 2018
• Study Start: June 28, 2018
• Primary Completion: August 31, 2018
• Study Completion: September 30, 2018
• Last Updated: March 1, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)