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Completed

NCT Number: NCT04665531

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

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.

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Key information

Conditions

Neoplasm of Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Thoracic Surgery, Video-Assisted

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Surgery Bitenc

Golnik, 4204, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erector Spinae Catheter

Procedure

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

intercostal block

Procedure

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

Ropivacaine 0.2% Injectable Solution

Drug

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Surgery Bitenc

Other

Registry information

Acronym: ESCAV

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 11, 2020
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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