NCT04062045

Efficacy of Continous Regional Anesthesia Using m. Erector Spinae Catheter After VATS Procedures

Efficacy of Continous Regional Anesthesia Using m. Erector Spinae Catheter After Video-assisted Thoracic Surgery Procedures

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Surgery Bitenc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Investigators will analyze the efficacy of continuous regional anesthesia through a catheter under erector spinae muscle in a prospective, randomized, double blind, placebo-controlled study. Investigators will include 50 adults, predicted for elective lung surgery with video-assisted thoracic surgery (VATS) technique. Patients will be randomly assigned to group A or B. Investigators will insert a catheter under the erector spinae muscle (ESC) at the T4 level of the operated side under ultrasound guidance. All patients will receive an initial bolus of 20ml levobupivacaine 0,5% through the catheter. Group A will receive a continuous infusion 5ml/h of ropivacaine 0,2% and intermittent boluses of the same local anesthetic 15ml/4h through the ESC. Group B will receive a continuous infusion of 0,9% saline in the same doses. All patients will have a PCA pump with piritramide 1mg/ml to cover the pain. All patients will receive regular doses of paracetamol and metamizole as part of multimodal analgesia. Investigators will compare pain, assessed with the VAS scale in resting and coughing and piritramide usage in both groups. Investigators will compare the incentive spirometry results at 24 and 48 hours postoperatively and observe for possible late complications.

Conditions

• Neoplasm of Lung
• Thoracic Surgery, Video-Assisted

Interventions

Type	Name	Description
DRUG	Ropivacaine Hcl 0.2% Inj Vil 10Ml	Group A will receive the medicine through the erector spinae catheter.
DRUG	Saline 0.9%	Group B will receive Saline 0,9% through the erector spinae catheter.

Timeline

• Start date: 2019-10-14
• Primary completion: 2021-11-01
• Completion: 2022-05-01
• First posted: 2019-08-20
• Last updated: 2020-11-13

Locations

1 site across 1 country: Slovenia