Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial)

NARecruitingINTERVENTIONAL
Enrollment

366

Participants

Timeline

Start Date

November 8, 2023

Primary Completion Date

February 1, 2028

Study Completion Date

November 1, 2028

Conditions
Pneumothorax, Primary SpontaneousVATSPain, PostoperativeLocoregional AnaesthesiaThoracic EpiduralChest Tube Drainage
Interventions
PROCEDURE

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).

PROCEDURE

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.

PROCEDURE

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"

PROCEDURE

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"

Trial Locations (1)

5504 DB

RECRUITING

Maxima MC, Veldhoven

Sponsors
All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

collaborator

Leiden University Medical Center

OTHER

lead

Maxima Medical Center

OTHER