Clinical trial NCT05491239: Optimal Postoperative Pain Management After Lung Surgery (OPtriAL)
Official title: Optimal Postoperative Pain Management After Lung Surgery (OPtriAL): Multi-centre Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Pain, Postoperative
VATS
Locoregional Anaesthesia
Thoracic Epidural
Lead sponsor: Maxima Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Amsterdam UMC
name: Radboud University Medical Center
First posted: 2022-08-08
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multi-centre randomised three-arm trial comparing continuous PVB, single-shot ICNB and TEA in a 1:1:1 ratio in patients who will undergo a VATS anatomic lung resection. We use a non-inferiority design with respect to the outcome measure 'pain' and a concomitant superiority design regarding 'quality of recovery'.
Primary purpose: TREATMENT

Brief summary: Adequate pain control after video-assisted thoracoscopic surgery (VATS) for lung resection is important to improve postoperative mobilisation, recovery, and to prevent pulmonary complications. So far, no consensus exists on optimal postoperative pain management after VATS anatomic lung resection.

Thoracic epidural analgesia (TEA) is the reference standard for postoperative pain management following VATS. Although the analgesic effect of TEA is clear, it is associated with patient immobilisation, bladder dysfunction and hypotension which may result in delayed recovery and longer hospitalisation. These disadvantages of TEA initiated the development of unilateral regional techniques for pain management. The most frequently used techniques are continuous paravertebral block (PVB) and single-shot intercostal nerve block (ICNB).

The investigators hypothesize that using either PVB or ICNB is non-inferior to TEA regarding postoperative pain and superior regarding quality of recovery (QoR). Signifying faster postoperative mobilisation, reduced morbidity and shorter hospitalisation, these techniques may therefore reduce health care costs and improve patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 years)
* Patients referred for anatomic lung resection (pneumonectomy, (bi)lobectomy or segmentectomy for either benign or malignant disease) with the intention of performing it by video-assisted thoracoscopic surgery (VATS) or robot-assisted thoracoscopic surgery (RATS)
* Patients should be able to provide informed consent and fill out questionnaires in Dutch language.

Exclusion Criteria:

* Patients with contra-indications for TEA or PVB (infection at skin site, increased intracranial pressure, non-correctable coagulopathy, bridging indication for therapeutic anticoagulation (CHADS-VASc ≥ 8), 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.
* In case the lung surgeon estimates the operation to be performed through a thoracotomy instead of VATS/RATS

Primary outcomes:
measure: Pain scores
timeFrame: Postoperative day 0-2
measure: Quality of Recovery (QoR)
timeFrame: Postoperative day 1-2
Secondary outcomes:
measure: cumulative use of opioids and analgesics
timeFrame: Postoperative day 0 until 3 as well as the use and dosage of opioid use at the follow-up period 2-3 weeks after the operation
measure: postoperative complications
timeFrame: until 2-3 weeks of follow-up
measure: hospitalisation
timeFrame: 30 postoperative days
measure: patient satisfaction
timeFrame: Postoperative day 0 until 3
measure: degree of mobility
timeFrame: Postoperative day 0 until 3
Other outcomes:
Locations:
city: Veldhoven
country: Netherlands
facility: Maxima MC
Study officials:
References:
citation: Spaans LN, Dijkgraaf MGW, Meijer P, Mourisse J, Bouwman RA, Verhagen AFTM, van den Broek FJC; OPtriAL study group. Optimal postoperative pain management after VATS lung resection by thoracic epidural analgesia, continuous paravertebral block or single-shot intercostal nerve block (OPtriAL): study protocol of a three-arm multicentre randomised controlled trial. BMC Surg. 2022 Sep 4;22(1):330. doi: 10.1186/s12893-022-01765-y.