postoperative pain
Conditions
Interventions
Intervention 1: continuous regional PVB
The PVB catheter is placed after general anaesthesia at the beginning of the
VATS/RATS procedure under direct thoracoscopic vision. If placement cannot be
ach
Sponsors
Maxima Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: Patients with contra-indications for TEA or PVB (infection at skin site, increased intracranial pressure, non-correctable coagulopathy, sepsis and mechanical spine obstruction) or allergic reactions to local anaesthetics will be excluded. Patients chronically using opioids for reasons not related to the operation will be excluded from the study since postoperative baseline opioid requirement will be higher and TEA remains the preferred technique for these patients. If, prior to the procedure, catheter placement during TEA is unsuccessful, a continuous PVB will be given during the procedure, and, if catheter placement during PVB is unsuccessful, a single shot multilevel ICNB will be used. Non-inferiority will be analysed based on intention-to-treat, as well as per-protocol analysis. In case the lung surgeon estimates the operation to be performed through a thoracotomy technique instead of a VATS the patient will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1) Pain scores during rest and mobilisation at baseline, in the morning, afternoon and evening on POD 0-3 and at 2-3 weeks follow-up; 2) Proportion of postoperative pain scores of NRS >=4 during mobilization at POD 0-3; 3) QoR-15 pre-operatively (baseline), POD 0, POD 3 and at 2-3 weeks follow-up; 4) Cumulative use of systemic opioids and analgesics at POD 0-3; 5) Postoperative complications until 2-3 weeks follow-up, according to the Clavien-Dindo classification; 6) Hospitalization, defined as the total number of days in hospital after the surgical intervention (including readmissions within the first 30 postoperative days). The following standardised discharge criteria after surgery will be applied in all participating hospitals: normal intake of nutrition; independent mobility; absence of fever ( | — |
Countries
Netherlands
Outcome results
None listed