Optimal Postoperative Pain Management After Lung Surgery (OPtriAL): Multi-centre Randomised Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Maxima Medical Center
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Pain scores
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Louisa Spaans
Coordinating Investigator, MD
Maxima Medical Center
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
Outcomes
Primary Outcomes
Pain scores
Time Frame: Postoperative day 0-2
Proportion of pain scores ≥4 as assessed by the numerical rating scale (NRS) (measured from 0 until 10; lowest value signifying no pain and highest value signifying worst pain)
Quality of Recovery (QoR)
Time Frame: Postoperative day 1-2
QoR measured with the QoR-15 questionnaire on postoperative 1 and 2 (maximum score of 150, the higher the score the better the outcome)
Secondary Outcomes
- cumulative use of opioids and analgesics(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)
- postoperative complications(until 2-3 weeks of follow-up)
- hospitalisation(30 postoperative days)
- patient satisfaction(Postoperative day 0 until 3)
- degree of mobility(Postoperative day 0 until 3)