- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03415555
Postoperative Analgesia After Minithoracotomy
Efficacy of Erector Spinae Plane (ESP) Blockade in Patients Scheduled for Minimally Invasively Mitral Valve Replacement
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Michał Borys, M.D., PhD
- Phone Number: 506350569
- Email: michalborys1@gmail.com
Study Locations
-
-
-
Rzeszów, Poland, 35-501
- Queen Jadwiga Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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:
Each patient will generally anesthetized and endotracheal tube will be inserted
Other Names:
Paracetamol will be given i.v.
every 6 hours.
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:
|
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.
|
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:
Each patient will generally anesthetized and endotracheal tube will be inserted
Other Names:
Paracetamol will be given i.v.
every 6 hours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From the end of anesthesia till 24 hour postoperatively
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Mirosław Czuczwar, M.D., PhD, Medical University of Lublin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antipyretics
- Analgesics, Opioid
- Narcotics
- Acetaminophen
- Oxycodone
Other Study ID Numbers
- KE-0254/26/2018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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