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

November 11, 2020 updated by: Surgery Bitenc

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Slovenia
      • Golnik, Slovenia, 4204
        • Recruiting
        • Surgery Bitenc
        • Contact:
        • Principal Investigator:
          • Polona Gams, MD
        • Sub-Investigator:
          • Nenad Danojević, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Ropivacaine Hcl 0.2% Inj Vil 10Ml
Group A will receive the medicine through the erector spinae catheter.
Placebo Comparator: 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.
Drug: Saline 0.9%
Group B will receive Saline 0,9% through the erector spinae catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usage of opioid analgetics
Time Frame: Continually 48 hours post surgery
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
Time Frame: 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.
Every hour in the 48 hours post surgery
Incentive spirometry
Time Frame: 24 and 48 hours after surgery
Investigators will assess spirometry with a manual device.
24 and 48 hours after surgery
Satisfaction with analgesia
Time Frame: 1 day (at dismissal from hospital.)
Investigators will assess satisfaction with qualitative and quantitative questionnaries.
1 day (at dismissal from hospital.)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 2 months
Investigators will follow up the patients in weeks after surgery for possible complications.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Surgery Bitenc

Investigators

  • Principal Investigator: Polona Gams, MD, Surgery Bitenc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2019

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

August 18, 2019

First Submitted That Met QC Criteria

August 19, 2019

First Posted (Actual)

August 20, 2019

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 11, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0120- 372/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymous IPD may be shared.

IPD Sharing Time Frame

After the collection of data has finished.

IPD Sharing Access Criteria

Primary researcher consent.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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