NCT03415555

Postoperative Analgesia After Minithoracotomy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Medical University of Lublin · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Postoperative Pain
• Mitral Valve Disease

Interventions

Type	Name	Description
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.
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.
PROCEDURE	general anesthesia	Each patient will generally anesthetized and endotracheal tube will be inserted
DRUG	paracetamol	Paracetamol will be given i.v. every 6 hours.

Timeline

• Start date: 2018-02-07
• Primary completion: 2018-04-18
• Completion: 2018-04-18
• First posted: 2018-01-30
• Last updated: 2023-11-28

Locations

1 site across 1 country: Poland