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

Surgery Bitenc

Status: Completed

Conditions: Neoplasm of Lung; Thoracic Surgery, Video-Assisted

Treatments: Procedure: Erector Spinae Catheter; Drug: Ropivacaine 0.2% Injectable Solution; Procedure: Intercostal block

Study type: Interventional

Funder types: Other

Identifiers

NCT04665531

0120- 372/2019A

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Group A - Erector Spinae Catheter group

Experimental group

Description:

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.

Treatment:

Drug: Ropivacaine 0.2% Injectable Solution

Procedure: Erector Spinae Catheter

Group B - Intercostal block

Active Comparator group

Description:

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.

Treatment:

Procedure: Intercostal block