Optimal Postoperative Pain Management After Lung Surgery (OPtriAL)

Maxima Medical Center

Status: Completed

Conditions: Pain, Postoperative; Locoregional Anaesthesia; Lung Cancer; Thoracic Epidural; VATS

Treatments: Procedure: Thoracic epidural analgesia; Procedure: Single shot intercostal nerve block; Procedure: Continuous regional paravertebral block

Study type: Interventional

Funder types: Other

Identifiers

NCT05491239

NL75375.041.20

Details and patient eligibility

About

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.

Enrollment: 450 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 3 patient groups

Thoracic epidural analgesia

Active Comparator group

Description:

See intervention description

Treatment:

Procedure: Thoracic epidural analgesia

Continuous regional paravertebral block

Experimental group

Description:

See intervention description

Treatment:

Procedure: Continuous regional paravertebral block

Single shot intercostal nerve block

Experimental group

Description:

See intervention description

Treatment:

Procedure: Single shot intercostal nerve block