366
Participants
Start Date
November 8, 2023
Primary Completion Date
February 1, 2028
Study Completion Date
November 1, 2028
Thoracic epidural analgesia
After correct placement of the epidural catheter, a local anaesthetic (ropivacaine, levobupivacaine or bupivacaine) will be started and, according to in house protocols, an opioid will be added to the epidural solution. A provisional stop of the administration of the epidural infusion is planned after 48 hours (on the second postoperative day).
Single-shot paravertebral block
At the beginning of surgery, before pleurectomy, a single shot PVB will be placed at 10 levels (T2-T11) by the surgeon with Ropivacaine 7.5mg/mL and 2-3mL per site under direct thoracoscopic vision. The injection site will be chosen at the paravertebral space, just lateral adjacent to the sympathetic trunk.
Late chest tube removal
"Postoperatively, the chest tube is connected to a Thopaz+ system (Medela inc.) and installed to -2 or -5 cm H2O.~The chest tube will be left in place during a fixed period of 3 postoperative days. The chest tube will be removed at the earliest at POD 3 in case the following criteria are met:~1. The patient is lucid and capable of sitting up straight in bed on his/her own~2. No air leakage indicated by the Thopaz+ system during at least 4 hours, or \<15 mL/min air leakage during at least 6 hours~3. Postoperative X ray (performed at least 4 hours after surgery or ultimately performed the morning of POD1) demonstrating complete lung expansion at the level of the hilum.~4. Absence of bloody drainage by the Thopaz+ system"
Early chest tube removal
"Postoperatively, the chest tube is connected to a Thopaz+ system (Medela inc.) and installed to -2 or -5 cm H2O.~The chest tube will be removed at the earliest at 4 hours postoperatively in case the following criteria are met:~1. The patient is lucid and capable of sitting up straight in bed on his/her own~2. No air leakage indicated by the Thopaz+ system during at least 4 hours, or \<15 mL/min air leakage during at least 6 hours~3. Postoperative X ray (performed at least 4 hours after surgery or ultimately performed the morning of POD1) demonstrating complete lung expansion at the level of the hilum.~4. Absence of pure blood drainage by the Thopaz+ system"
RECRUITING
Maxima MC, Veldhoven
Lead Sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Leiden University Medical Center
OTHER
Maxima Medical Center
OTHER