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Postoperative Analgesia After Minithoracotomy

M

Medical University of Lublin

Status and phase

Completed
Phase 4

Conditions

Mitral Valve Disease
Postoperative Pain

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03415555
KE-0254/26/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

19 participants in 2 patient groups

ESP
Experimental group
Description:
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.
Treatment:
Procedure: Erector Spinae Plane blockade
Procedure: general anesthesia
Drug: Oxycodone
Drug: paracetamol
PCA
Experimental group
Description:
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.
Treatment:
Procedure: general anesthesia
Drug: Oxycodone
Drug: paracetamol

Trial contacts and locations

1

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Central trial contact

Michał Borys, M.D., PhD

Data sourced from clinicaltrials.gov

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