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Postoperative Analgesia After Minithoracotomy

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ClinicalTrials.gov Identifier: NCT03415555
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
Medical University of Rzeszów
Information provided by (Responsible Party):
Michał Borys, Medical University of Lublin

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Mitral Valve Disease Procedure: Erector Spinae Plane blockade Drug: Oxycodone Procedure: general anesthesia Drug: paracetamol Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Single (Participant)
Masking Description: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Erector Spinae Plane (ESP) Blockade in Patients Scheduled for Minimally Invasively Mitral Valve Replacement
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : May 7, 2018
Estimated Study Completion Date : June 4, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Oxycodone

Arm Intervention/treatment
Experimental: ESP
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
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 Name: ESP

Drug: Oxycodone
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 Name: PCA with oxycodone

Procedure: general anesthesia
Each patient will generally anesthetized and endotracheal tube will be inserted
Other Name: GA

Drug: paracetamol
Paracetamol will be given i.v. every 6 hours.

Experimental: PCA
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
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 Name: PCA with oxycodone

Procedure: general anesthesia
Each patient will generally anesthetized and endotracheal tube will be inserted
Other Name: GA

Drug: paracetamol
Paracetamol will be given i.v. every 6 hours.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03415555


Contacts
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Contact: Michał Borys, M.D., PhD 506350569 michalborys1@gmail.com

Locations
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Poland
Queen Jadwiga Hospital Recruiting
Rzeszów, Poland, 35-501
Contact: Beata Horeczy, M.D.    +48 784445414    beata.horeczy@yahoo.com   
Sponsors and Collaborators
Medical University of Lublin
Medical University of Rzeszów
Investigators
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Study Chair: Mirosław Czuczwar, M.D., PhD Medical University of Lublin

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Responsible Party: Michał Borys, associate professor, Medical University of Lublin
ClinicalTrials.gov Identifier: NCT03415555     History of Changes
Other Study ID Numbers: KE-0254/26/2018
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michał Borys, Medical University of Lublin:
Erector Spinae Plane blockade
patient control anlagesia
mitral valve replacement

Additional relevant MeSH terms:
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Oxycodone
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Anesthetics
Acetaminophen
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antipyretics
Analgesics, Opioid
Narcotics