Optimal postoperative Pain management After Lung surgery (OPtriAL): multi-centre randomised trial

Completed

Conditions: postoperative pain
10038737

Registration Number: NL-OMON52222

Lead Sponsor: Maxima Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 420

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The NRS (0-10; 0= no pain, 10=worst imaginable pain) will be used to measure<br /><br>pain scores. The primary outcome measure for non-inferiority is the<br /><br>proportion of NRS >=4, defined as the number of NRS >=4 episodes divided by the<br /><br>total amount of NRS pain scores obtained. A minimum of 11 NRS pain scores will<br /><br>be collected (at the recovery room (1), on the ward (10)). The primary outcome<br /><br>for superiority is QoR measured with the QoR-15 questionnaire on POD 1 and<br /><br>POD 2. The QoR-15 will provide a continuous variable with a minimum score of 0<br /><br>and maximum score of 150, and contains the most relevant questions concerning 5<br /><br>domains (emotional status, physical comfort, psychological support, physical<br /><br>independence and pain) of overall well-being and recovery after surgery.</p><br>

Secondary Outcome Measures