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

Not Applicable

• Conditions: Neoplasm of Lung; Thoracic Surgery, Video-Assisted
• Interventions: Drug: Ropivacaine Hcl 0.2% Inj Vil 10Ml; Drug: Saline 0.9%

• Registration Number: NCT04062045
• Lead Sponsor: Surgery Bitenc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-18
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-20
• Study Start: 2019-10-14
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-11
• Last Update Posted: 2020-11-13
• Primary Completion: 2021-11
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A - Local anesthetic group	Ropivacaine Hcl 0.2% Inj Vil 10Ml	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	Saline 0.9%	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.

Primary Outcome Measures

Name	Time	Method
Usage of opioid analgetics	Continually 48 hours post surgery	Investigators will measure the total consumption of i.v. piritramide after surgery.

Secondary Outcome Measures

Name	Time	Method
Subjective pain score	Every hour in the 48 hours post surgery	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.
Incentive spirometry	24 and 48 hours after surgery	Investigators will assess spirometry with a manual device.
Satisfaction with analgesia	1 day (at dismissal from hospital.)	Investigators will assess satisfaction with qualitative and quantitative questionnaries.

Trial Locations

Locations (1)

Surgery Bitenc; 🇸🇮 Golnik, Slovenia