Efficacy of Continous Regional Anesthesia Using m. Erector Spinae Catheter After Video-assisted Thoracic Surgery Procedures
Overview
- Phase
- Not Applicable
- Intervention
- Ropivacaine Hcl 0.2% Inj Vil 10Ml
- Conditions
- Neoplasm of Lung
- Sponsor
- Surgery Bitenc
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Usage of opioid analgetics
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed written informed consent
- •ASA I-III
- •Elective video-assisted thoracic surgery with 3 ports technique
- •No contraindications for regional anesthesia
Exclusion Criteria
- •Allergy to local anesthetic
- •Pregnancy, breastfeeding
- •Inflammation in the area of ES catheter insertion
- •Inability to use the PCA pump
Arms & Interventions
Group A - Local anesthetic group
Group A will receive a continuous infusion of ropivacaine 0,2% 5ml/h and intermittent boluses of the same local anesthetic 15ml/4h through the erector spinae catheter.
Intervention: Ropivacaine Hcl 0.2% Inj Vil 10Ml
Group B - Placebo group
Group B will receive a continuous infusion of 0,9% saline 5ml/h and intermittent boluses of the same fluid 15ml/4h through the erector spinae catheter.
Intervention: Saline 0.9%
Outcomes
Primary Outcomes
Usage of opioid analgetics
Time Frame: Continually 48 hours post surgery
Investigators will measure the total consumption of i.v. piritramide after surgery.
Secondary Outcomes
- Subjective pain score(Every hour in the 48 hours post surgery)
- Incentive spirometry(24 and 48 hours after surgery)
- Satisfaction with analgesia(1 day (at dismissal from hospital.))