Clinical trial · Interventional
Optimal Postoperative Pain Management After Lung Surgery (OPtriAL)
Optimal Postoperative Pain Management After Lung Surgery (OPtriAL): Multi-centre Randomised Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locoregional Anaesthesia | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Pain, Postoperative | — | UNRESOLVED | — |
| Thoracic Epidural | — | UNRESOLVED | — |
| VATS | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Continuous regional paravertebral block | Procedure | — | UNRESOLVED |
| Single shot intercostal nerve block | Procedure | — | UNRESOLVED |
| Thoracic epidural analgesia | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Thoracic epidural analgesia
- description
- See intervention description
- interventionNames
- Procedure: Thoracic epidural analgesia
- type
- EXPERIMENTAL
- label
- Continuous regional paravertebral block
- description
- See intervention description
- interventionNames
- Procedure: Continuous regional paravertebral block
- type
- EXPERIMENTAL
- label
- Single shot intercostal nerve block
- description
- See intervention description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDSpaans LN, Dijkgraaf MGW, Susa D, de Loos ER, Mourisse JMJ, Bouwman RA, Verhagen AFTM, van den Broek FJC; OPtriAL Study Group; Meijer P, Kuut M, Hanneman N, Bousema J, Franssen A, Brokx H, van Duyn E, Potters JW, van den Broek R, van Brakel T, Rijna H, Boom A, Noyez V, Hendriks JMH, Yogeswaran SK, Dickhoff C, van Dorp M. Intercostal or Paravertebral Block vs Thoracic Epidural in Lung Surgery: A Randomized Noninferiority Trial. JAMA Surg. 2025 Aug 1;160(8):855-864. doi: 10.1001/jamasurg.2025.1899. PMID 40560556
- DERIVEDSpaans 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. PMID 36058900