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Clinical Trials/NCT04665531
NCT04665531
Completed
Not Applicable

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

Surgery Bitenc1 site in 1 country50 target enrollmentFebruary 19, 2020

Overview

Phase
Not Applicable
Intervention
Erector Spinae Catheter
Conditions
Neoplasm of Lung
Sponsor
Surgery Bitenc
Enrollment
50
Locations
1
Primary Endpoint
Demand for opioid analgetics
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 19, 2020
End Date
June 14, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Surgery Bitenc
Responsible Party
Sponsor

Eligibility Criteria

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
  • Inflammation in the area of ES catheter insertion
  • Inability to use the PCA pump
  • Inability to execute the main inspiratory and expiratory pressure measurements

Arms & Interventions

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.

Intervention: Erector Spinae Catheter

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.

Intervention: Ropivacaine 0.2% Injectable Solution

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.

Intervention: Intercostal block

Outcomes

Primary Outcomes

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.

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

  • Subjective pain score(Every hour in the 48 hours post surgery.)

Study Sites (1)

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