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Research question

Is thoracic epidural analgesia necessary for optimal postoperative pain management and quality of recovery (QoR) after video-assisted thoracic surgery (VATS) or can alternative unilateral regional techniques such as continuous paravertebral block (PVB) or single shot multi-level intercostal nerve block (ICNB) improve these aspects with a reduction in epidural related complications?

 

Hypothesis

Continuous PVB or single shot multi-level ICNB is non-inferior to TEA regarding pain, but superior regarding faster postoperative mobilization, reduced morbidity and shorter hospitalization resulting in better QoR. In addition, ICNB is deemed more cost-effective than PVB and TEA.

 

Study design

Three-armed randomized trial comparing PVB, ICNB and TEA in a 1:1:1 ratio for pain (non-inferiority) and for QoR (superiority).

 

Study population

Patients referred for anatomical lung resection performed by VATS without contra-indications for either PVB, ICNB or TEA, and without allergic reactions to analgesics.

 

Usual care

TEA placed preoperatively by the anesthesiologist. TEA is removed at postoperative day (POD) 2 in case of adequate pain control.

 

Intervention

Continuous PVB or multi-level ICNB analgesic procedures are performed intraoperatively under direct thoracoscopic vision. In the case of PVB a catheter will be placed in the paravertebral space for continuous infusion of analgesics. The catheter is removed at POD 2 in case of adequate pain control.

The three groups will have the same pre- and postoperative pain protocols.

 

Outcome measures

Primary outcome measure for non-inferiority is the proportion pain scores =4 divided by the total amount of obtained pain scores during POD 0-3. Primary outcome for superiority is QoR measured with the QoR-15 questionnaire on POD 1-2. Secondary outcomes will be QoR at POD 3 and 30 day follow up, additional opioid use, morbidity, hospitalization, patient satisfaction, degree of mobility and costs.

 

Sample size

571 patients.

 

 

 

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