Optimal Postoperative Pain Management After Lung Surgery (OPtriAL)

Not Applicable

Completed

• Conditions: Lung Cancer; VATS; Locoregional Anaesthesia; Pain, Postoperative; Thoracic Epidural
• Interventions: Procedure: Continuous regional paravertebral block; Procedure: Thoracic epidural analgesia; Procedure: Single shot intercostal nerve block

• Registration Number: NCT05491239
• Lead Sponsor: Maxima Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-05
• Study First Posted: 2022-08-08
• Primary Completion: 2023-10-01
• Study Completion: 2023-11-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous regional paravertebral block	Continuous regional paravertebral block	See intervention description
Thoracic epidural analgesia	Thoracic epidural analgesia	See intervention description
Single shot intercostal nerve block	Single shot intercostal nerve block	See intervention description

Primary Outcome Measures

Name	Time	Method
Pain scores	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)	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 Outcome Measures

Name	Time	Method
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	total opioid and non-opioid consumption as supplementary analgesic requirement
postoperative complications	until 2-3 weeks of follow-up	according to the Clavien-Dindo classification;
hospitalisation	30 postoperative days	defined as the total number of days in hospital after the surgical intervention (including readmissions within the first 30 postoperative days), the following standardised discharge criteria after surgery will be applied in all participating hospitals: normal intake of nutrition, independent mobility, absence of fever (\<38 °C), and no presence of chest tube;
patient satisfaction	Postoperative day 0 until 3	5-point Likert scale: not at all satisfied, slightly satisfied, neutral, very satisfied and extremely satisfied
degree of mobility	Postoperative day 0 until 3	4-point scale: on the bed (1), to the chair (2), to the toilet (3), outside the patient's hospital room(4)

Trial Locations

Locations (1)

Maxima MC; 🇳🇱 Veldhoven, Netherlands