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Completed

NCT Number: NCT03415555

Postoperative Analgesia After Minithoracotomy

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.

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Key information

Conditions

Postoperative Pain Mitral Valve Disease Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Queen Jadwiga Hospital

Rzeszów, 35-501, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Other names: PCA with oxycodone

General Anesthesia

Procedure

Each patient will generally anesthetized and endotracheal tube will be inserted

Other names: GA

Paracetamol

Drug

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

Primary outcomes

  1. Pain intensity

    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).

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

Secondary outcomes

  1. Total consumption of oxycodone

    Time frame: From the end of anesthesia till 24 hour postoperatively

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

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Collaborators

  • University of Rzeszow

Registry information

Official study title

Efficacy of Erector Spinae Plane (ESP) Blockade in Patients Scheduled for Minimally Invasively Mitral Valve Replacement

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 30, 2018
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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