Postoperative Analgesia After Minithoracotomy

NCT03415555 | Completed Phase 4

• 1 other identifier: KE-0254/26/2018
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Mitral Valve Disease

Keywords

Erector Spinae Plane blockade; patient control anlagesia; mitral valve replacement

Outcome Measures

Primary Outcomes (1)

• Pain intensity

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

  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 Outcomes (1)

• Total consumption of oxycodone

  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

PCA

EXPERIMENTAL

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.

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: 0.2 mL per patients' KG. The maximum dose is 40 mL.

Also known as: ESP

ESP

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.

Also known as: PCA with oxycodone

ESP; PCA

general anesthesia PROCEDURE

Each patient will generally anesthetized and endotracheal tube will be inserted

Also known as: GA

ESP; PCA

paracetamol DRUG

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

ESP; PCA

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
• postoperative ventilation or ICU admission

Sponsors & Collaborators

• Medical University of Lublin: lead
• University of Rzeszow: collaborator

Study Sites (1)

Queen Jadwiga Hospital

Rzeszów, 35-501, Poland

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Oxycodone; Passive Cutaneous Anaphylaxis; 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; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena; Anesthesia; Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mirosław Czuczwar, M.D., PhD

  Medical University of Lublin

  STUDY CHAIR

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: associate professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: January 30, 2018
• Study Start: February 7, 2018
• Primary Completion: April 18, 2018
• Study Completion: April 18, 2018
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

PL (1)