Neoplasm of Lung, Thoracic Surgery, Video-Assisted
Conditions
Keywords
Anesthesia, Conduction
Brief summary
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.
Interventions
DRUGRopivacaine Hcl 0.2% Inj Vil 10Ml
Group A will receive the medicine through the erector spinae catheter.
DRUGSaline 0.9%
Group B will receive Saline 0,9% through the erector spinae catheter.
Sponsors
Surgery Bitenc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Masking the infusion mixture by using the same shape of the drug/placebo bottle and wrapping it into non-transparent sheath.
Intervention model description
Prospective, randomized, double blind, placebo controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed written informed consent * ASA I-III * Elective video-assisted thoracic surgery 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usage of opioid analgetics | Continually 48 hours post surgery | Investigators will measure the total consumption of i.v. piritramide after surgery. |
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 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. |
| Incentive spirometry | 24 and 48 hours after surgery | Investigators will assess spirometry with a manual device. |
| Satisfaction with analgesia | 1 day (at dismissal from hospital.) | Investigators will assess satisfaction with qualitative and quantitative questionnaries. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Complications | 2 months | Investigators will follow up the patients in weeks after surgery for possible complications. |
Countries
Slovenia
Contacts
Primary ContactPolona Gams, MD
Backup ContactMaja Šoštarič, MD, as. prof
Outcome results
None listed