Neoplasm of Lung, Thoracic Surgery, Video-Assisted
Conditions
Keywords
Anesthesia, Conduction, Regional Anesthesia, Post-operative Analgesia
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.
Interventions
PROCEDUREErector 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.
PROCEDUREIntercostal 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.
DRUGRopivacaine 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.
Sponsors
Surgery Bitenc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
Prospective, randomised, controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demand for opioid analgetics | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective pain score | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with late post-operative complications | 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. |
Countries
Slovenia
Outcome results
None listed