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Ropivacaine

Anesthetics, Local

Levobupivacaine

Analgesics, Opioid

Dipyrone

Pirinitramide

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.

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.

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.

Erector Spinae Catheter

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.

Intercostal block

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.

Ropivacaine 0.2% Injectable Solution

Polona Gams

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.

The method of treatment is obvious and cannot be masked for care providers and investigators. Data will be non-labelled and therefore concealed before the outcomes assessor.

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

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.

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.

Investigators will compare the change between pre- and post-operative main inspiratory pressure and main expiratory pressure measurements between the two research groups.

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.

Surgery Bitenc

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.

Group A will receive the medicine through the erector spinae catheter.

Ropivacaine Hcl 0.2% Inj Vil 10Ml

Group B will receive Saline 0,9% through the erector spinae catheter.

Saline 0.9%

Polona Gams, MD

Maja Šoštarič, MD, as. prof

Nenad Danojević, MD

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.

Prospective, randomized, double blind, placebo controlled

Masking the infusion mixture by using the same shape of the drug/placebo bottle and wrapping it into non-transparent sheath.

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

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

Investigators will follow up the patients in weeks after surgery for possible complications.

Investigators will measure the total consumption of i.v. piritramide after 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.

Investigators will assess spirometry with a manual device.

Investigators will assess satisfaction with qualitative and quantitative questionnaries.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Postoperative Analgesia With a Catheter Under the Erector Spinae Muscle for Videothoracoscopic Lung Surgery	NCT04665531	Neoplasm of Lun... Thoracic Surger...	Erector Spinae ... Intercostal blo... Ropivacaine 0.2...	18 Years -	Surgery Bitenc
Efficacy of Continous Regional Anesthesia Using m. Erector Spinae Catheter After VATS Procedures	NCT04062045	Neoplasm of Lun... Thoracic Surger...	Ropivacaine Hcl... Saline 0.9%	18 Years -	Surgery Bitenc

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