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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neoplasm of Lung, Thoracic Surgery, Video-Assisted

Intervention / Treatment
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* Drug: Ropivacaine Hcl 0.2% Inj Vil 10Ml
* Drug: Saline 0.9%


Participation Criteria
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Eligibility Criteria
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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 BMI>35 Inflammation in the area of ES catheter insertion Inability to use the PCA pump

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, double blind, placebo controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A - Local anesthetic group<br>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. | Drug: Ropivacaine Hcl 0.2% Inj Vil 10Ml<br>* Group A will receive the medicine through the erector spinae catheter.<br>|
| Placebo Comparator: Group B - Placebo group<br>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. | Drug: Saline 0.9%<br>* Group B will receive Saline 0,9% through the erector spinae catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usage of opioid analgetics | Investigators will measure the total consumption of i.v. piritramide after surgery. | Continually 48 hours post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective pain score | Investigators will measure subjective perception of pain with the visual analogue scale (VAS) scoring system at resting and coughing. The VAS scoring system is a numerical scale from 0-10, with 0 being no pain and 10 the strongest pain imaginable. Patients will assess their pain with the help of analogue scale with colours and faces by each number representing different VAS pain levels. | Every hour in the 48 hours post surgery | 
| Incentive spirometry | Investigators will assess spirometry with a manual device. | 24 and 48 hours after surgery | 
| Satisfaction with analgesia | Investigators will assess satisfaction with qualitative and quantitative questionnaries. | 1 day (at dismissal from hospital.) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Conduction