Trial | NCT04062045  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    50
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.
Study Started
Oct 14
2019
Primary Completion
Nov 30
2021
Anticipated
Study Completion
May 31
2022
Anticipated
Last Update
Nov 13
2020

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.

Group A - Local anesthetic group Experimental

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.

Group B - Placebo group Placebo Comparator

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.

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
BMI>35
Inflammation in the area of ES catheter insertion
Inability to use the PCA pump
No Results Posted