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

Primary Purpose

Neoplasm of Lung, Thoracic Surgery, Video-Assisted

Status
Unknown status
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Ropivacaine Hcl 0.2% Inj Vil 10Ml
Saline 0.9%
Sponsored by
Surgery Bitenc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasm of Lung focused on measuring Anesthesia, Conduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Surgery BitencRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A - Local anesthetic group

Group B - Placebo group

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Usage of opioid analgetics
Investigators will measure the total consumption of i.v. piritramide after surgery.

Secondary Outcome Measures

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.
Incentive spirometry
Investigators will assess spirometry with a manual device.
Satisfaction with analgesia
Investigators will assess satisfaction with qualitative and quantitative questionnaries.

Full Information

First Posted
August 18, 2019
Last Updated
November 11, 2020
Sponsor
Surgery Bitenc
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1. Study Identification

Unique Protocol Identification Number
NCT04062045
Brief Title
Efficacy of Continous Regional Anesthesia Using m. Erector Spinae Catheter After VATS Procedures
Official Title
Efficacy of Continous Regional Anesthesia Using m. Erector Spinae Catheter After Video-assisted Thoracic Surgery Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Surgery Bitenc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm of Lung, Thoracic Surgery, Video-Assisted
Keywords
Anesthesia, Conduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, double blind, placebo controlled
Masking
ParticipantCare ProviderInvestigator
Masking Description
Masking the infusion mixture by using the same shape of the drug/placebo bottle and wrapping it into non-transparent sheath.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A - Local anesthetic group
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B - Placebo group
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Ropivacaine Hcl 0.2% Inj Vil 10Ml
Intervention Description
Group A will receive the medicine through the erector spinae catheter.
Intervention Type
Drug
Intervention Name(s)
Saline 0.9%
Intervention Description
Group B will receive Saline 0,9% through the erector spinae catheter.
Primary Outcome Measure Information:
Title
Usage of opioid analgetics
Description
Investigators will measure the total consumption of i.v. piritramide after surgery.
Time Frame
Continually 48 hours post surgery
Secondary Outcome Measure Information:
Title
Subjective pain score
Description
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.
Time Frame
Every hour in the 48 hours post surgery
Title
Incentive spirometry
Description
Investigators will assess spirometry with a manual device.
Time Frame
24 and 48 hours after surgery
Title
Satisfaction with analgesia
Description
Investigators will assess satisfaction with qualitative and quantitative questionnaries.
Time Frame
1 day (at dismissal from hospital.)
Other Pre-specified Outcome Measures:
Title
Complications
Description
Investigators will follow up the patients in weeks after surgery for possible complications.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 BMI>35 Inflammation in the area of ES catheter insertion Inability to use the PCA pump
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Polona Gams, MD
Phone
00386 41 522 968
Email
polona.gams@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maja Šoštarič, MD, as. prof
Email
maja.sos@siol.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Polona Gams, MD
Organizational Affiliation
Surgery Bitenc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Surgery Bitenc
City
Golnik
ZIP/Postal Code
4204
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Polona Gams, MD
Email
polona.gams@gmail.com
First Name & Middle Initial & Last Name & Degree
Polona Gams, MD
First Name & Middle Initial & Last Name & Degree
Nenad Danojević, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
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Efficacy of Continous Regional Anesthesia Using m. Erector Spinae Catheter After VATS Procedures

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