Optimal Postoperative Pain Management After Lung Surgery (OPtriAL)

NCT05491239 | Completed DMC

• 1 other identifier: NL75375.041.20
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Pain scores

  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)

  Postoperative day 0-2

• Quality of Recovery (QoR)

  QoR measured with the QoR-15 questionnaire on postoperative 1 and 2 (maximum score of 150, the higher the score the better the outcome)

  Postoperative day 1-2

Secondary Outcomes (5)

• 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

Study Arms (3)

Thoracic epidural analgesia

ACTIVE COMPARATOR

See intervention description

Procedure: Thoracic epidural analgesia

Continuous regional paravertebral block

EXPERIMENTAL

See intervention description

Procedure: Continuous regional paravertebral block

Single shot intercostal nerve block

EXPERIMENTAL

See intervention description

Procedure: Single shot intercostal nerve block

Interventions

Thoracic epidural analgesia PROCEDURE

After correct placement of the epidural catheter, a local anaesthetic (ropivacaine, levobupivacaine or bupivacaine) will be started and, according to in house protocols, an opioid will be added to the epidural solution. A provisional stop of the administration of the epidural infusion is planned after 48 hours (on the second postoperative day).

Thoracic epidural analgesia

Continuous regional paravertebral block PROCEDURE

The PVB catheter is placed under general anaesthesia at the beginning of the VATS procedure under direct thoracoscopic vision. The level of the PVB catheter placement is chosen at the intercostal space of the largest incision (mostly thoracic level 4 or 5). Under direct thoracoscopic vision, the surgeon inserts a Touhy needle. The tip of the needle is observed beneath the pleural surface thoracoscopically. Injection of about 2 mL ropivacaine 7.5mg/mL will create subpleural hydrodissection to reach the adequate paravertebral plane for placement of the catheter. The PVB catheter is subsequently placed under direct thoracoscopic vision and left next to the sympathetic chain in the paravertebral space. Next, a bolus of ropivacaine (total amount 20 mL including the given amount for hydrodissection) is given through the catheter. Postoperatively, a ropivacaine 2 mg/mL pump for continuous infusion is given with an infusion rate of 8-14 ml/hour.

Continuous regional paravertebral block

Single shot intercostal nerve block PROCEDURE

At the end of the surgery a single shot ICNB will be placed at 9 levels (thoracic level 2 to 10) with 2-3mL local anaesthetics per intercostal space under direct thoracoscopic vision. The injection site will be chosen just lateral from the sympathetic trunk. This group will have no analgesic catheters for continuous analgesia. No mobility restrictions are instructed in this group.

Single shot intercostal nerve block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maxima Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Amsterdam UMC: collaborator
• Radboud University Medical Center: collaborator

Study Sites (1)

Maxima MC

Veldhoven, 5504 DB, Netherlands

Location

Related Publications (2)

• Spaans 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 DERIVED

• 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.

  PMID: 36058900 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Pain, Postoperative

Interventions

Tea

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: As the analgesic strategies highly differ in nature (with or without percutaneous catheter) and/or postoperative care (mobility with or without prerequisites, urinary catheter placement), blinding for the randomised strategy is unfeasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator, MD

Model Details: 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'.

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 8, 2022
• Study Start: March 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

NL (1)