Optimal postoperative Pain management After Lung surgery
Recruiting
- Conditions
- ung tumor
- Registration Number
- NL-OMON21054
- Lead Sponsor
- ZonMw, Maxima MC
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 571
Inclusion Criteria
Patients referred for anatomical lung resection (pneumonectomy, (bi)lobectomy or segmentectomy) with the intention of performing it by VATS or RATS are eligible for the trial.
- Adult patients older than 18 years who are able to give informed consent and fill out questionnaires in Dutch.
Exclusion Criteria
- Contra-indications TEA or PVB (infection at skin site, increased intracranial pressure, non-correctable coagulopathy, bridging indication for therapeutic anticoagulation (CHADS-VASc = 8), sepsis and mechanical spine obstruction)
- Allergy to local anaesthetics
- Chronic use of opioids
- In case the lung surgeon estimates the operation to be performed through a thoracotomy technique instead of a VATS the patient will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The NRS (0-10; 0= no pain, 10=worst imaginable pain) will be used to measure pain scores. The primary outcome measure for ‘non-inferiority’ is the proportion of NRS =4, defined as the number of NRS =4 episodes divided by the total amount of NRS pain scores obtained. A minimum of 11 NRS pain scores will be collected (at the recovery room (1), on the ward (10)). The primary outcome for ‘superiority’ is QoR measured with the QoR-15 questionnaire on POD 1 and POD 2. The QoR-15 will provide a continuous variable with a minimum score of 0 and maximum score of 150, and contains the most relevant questions concerning 5 domains (emotional status, physical comfort, psychological support, physical independence and pain) of overall well-being and recovery after surgery.
- Secondary Outcome Measures
Name Time Method