Postoperative Analgesia With a Catheter Under the Erector Spinae Muscle for Videothoracoscopic Lung Surgery (ESCAV)

July 18, 2022 updated by: Surgery Bitenc
The purpose of the research is to prove the analgesic efficacy of a novel technique in regional anaesthesia, i.e. the catheter under the erector spinae muscle (ESC). Investigators will evaluate the use of the ESC for analgesia after video-assisted thoracoscopic lung surgeries in comparison to the standard method of post-operative analgesia, which is the multiple level intercostal block given at the end of surgery by the surgeon. Investigators will compare the amount of opioid analgesics required by the patient using the patient controlled pump, the pain status in 48-hours after surgery and compare the differences between pre- and post-operative main inspiratory pressure and main expiratory pressure measurements between the two research groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • Slovenia
      • Golnik, Slovenia, 4204
        • Surgery Bitenc

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 (American Society of Anesthesiologists status) I-III
  • Elective video-assisted thoracic surgery - lobectomy 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
  • Inability to execute the main inspiratory and expiratory pressure measurements

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group A - Erector Spinae Catheter group

Patients in the experimental group will receive the erector spinae catheter prior the surgery and will be administered local anesthetics for 48 hours post-operatively.

Anesthetic regimen: initial bolus of 20ml 0.5% levobupivacaine before the end of surgery. Then continually ropivacaine 0,2% 5ml/h with intermittent boluses 15ml ropivacaine 0,2% every 4h.

Both groups will receive multimodal analgetic treatment consisting of a patient-controlled (PCA) pump with opioid analgetics and a peripherally acting analgetic metamizol on a regular basis. The PCA pump will be set to intermittent boluses of 3mg piritramide with a lock-out time 15 min and a maximal number of 6 boluses /3 hours. Patients will receive metamizol 2,5g/12hours i.v. on the day of surgery and 500-1000mg / 6 hours orally on the first and second post-operative day.
Procedure: Erector Spinae Catheter
Patients in the experimental group will receive the Erector Spinae Catheter with an initial bolus ob 20ml 0,5% levobupivacaine prior the surgery and will be administered local anesthetics for 48 hours post-operatively.
Other Names:
  • continuous regional analgesia
Drug: Ropivacaine 0.2% Injectable Solution
Patients in the experimental group will receive Ropivacaine 0,2% continous infusion of 5ml/h with boluses 15ml/4h by the Erector Spinae Catheter for 48 hours post-operatively.
ACTIVE_COMPARATOR: Group B - Intercostal block

Patients will receive standard treatment, i.e. the multi-level intercostal block administered at the end of the surgery by the surgeon. They will receive 20ml 0,5% levobupivacaine on 6 levels of the thoracic wall according to the operative wound level.

Both groups will receive multimodal analgetic treatment consisting of a patient-controlled (PCA) pump with opioid analgetics and a peripherally acting analgetic metamizol on a regular basis. The PCA pump will be set to intermittent boluses of 3mg piritramide with a lock-out time 15 min and a maximal number of 6 boluses /3 hours. Patients will receive metamizol 2,5g/12hours i.v. on the day of surgery and 500-1000mg / 6 hours orally on the first and second post-operative day.
Procedure: Intercostal block
Patients in the comparative group will receive standard treatment, i.e. the multi-level intercostal block with 20ml 0,5% levobupivacaine administered at the end of the surgery by the surgeon.
Other Names:
  • Single shot regional analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demand for opioid analgetics
Time Frame: Continually 48 hours after surgery
Investigators will measure the total consumption of i.v. piritramide after surgery given by the PCA (patient-controlled analgesia) pump. The PCA pump automatically marks all the drug consumption. The PCA pump will be set to a uniform protocol: piritramide 1mg/ml; flow 0ml/h, bolus 3ml, lockout time 15 min, max 4 boluses / hour.
Continually 48 hours after surgery
Difference in pre- and post-operative respiratory muscle fitness
Time Frame: First postoperative day
Investigators will compare the change between pre- and post-operative main inspiratory pressure and main expiratory pressure measurements between the two research groups.
First postoperative day
Difference in pre- and post-operative respiratory muscle fitness
Time Frame: Second postoperative day
Investigators will compare the change between pre- and post-operative main inspiratory pressure and main expiratory pressure measurements between the two research groups.
Second postoperative day

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 nubmering rating score (NRS) scoring system at resting and coughing. The NRS 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 NRS pain levels.
Every hour in the 48 hours post surgery.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with late post-operative complications
Time Frame: 2 months
Investigators will follow up the patients in 4 and 12 weeks after surgery for possible complications. The complications will be read from the follow up documentation in observed patient files. Investigators will search for complications such as arrhythmias, lung or wound infections, lethalities or other unexpected 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, 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)

February 19, 2020

Primary Completion (ACTUAL)

March 14, 2022

Study Completion (ACTUAL)

June 14, 2022

Study Registration Dates

First Submitted

November 11, 2020

First Submitted That Met QC Criteria

December 6, 2020

First Posted (ACTUAL)

December 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0120- 372/2019A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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