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AzTrials

Lung CancerNCT05491239

Optimal Postoperative Pain Management After Lung Surgery (OPtriAL)

A study testing Thoracic epidural analgesia, Continuous regional paravertebral block and Single shot intercostal nerve block in people with Lung Cancer and Pain, Postoperative, run by Maxima Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Pain, Postoperative, VATS
What is being tested?
Thoracic epidural analgesia, Continuous regional paravertebral block and Single shot intercostal nerve block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
1 siteNetherlands
Study dates
1 Mar 2021to 1 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maxima MC

    Veldhoven, 5504 DB

Other trials in Netherlands

About this study

Official title: Optimal Postoperative Pain Management After Lung Surgery (OPtriAL): Multi-centre Randomised Trial

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.

Being tested
Thoracic epidural analgesia, Continuous regional paravertebral block, Single shot intercostal nerve block
Medical subject headings
Lung Neoplasms, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thoracic epidural analgesiaProcedure or surgery

    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).

  • Continuous regional paravertebral blockProcedure or surgery

    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.

  • Single shot intercostal nerve blockProcedure or surgery

    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.

Study groups in NCT05491239
Study groupRoleWhat they receive
Thoracic epidural analgesiaActive comparatorSee intervention description
Receives: Procedure: Thoracic epidural analgesia
Continuous regional paravertebral blockExperimentalSee intervention description
Receives: Procedure: Continuous regional paravertebral block
Single shot intercostal nerve blockExperimentalSee intervention description
Receives: Procedure: Single shot intercostal nerve block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Postoperative day 0-2

  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)

    Measured: Postoperative day 1-2

Secondary outcomes (5)

  1. cumulative use of opioids and analgesics

    total opioid and non-opioid consumption as supplementary analgesic requirement

    Measured: 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

  2. postoperative complications

    according to the Clavien-Dindo classification;

    Measured: until 2-3 weeks of follow-up

  3. hospitalisation

    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;

    Measured: 30 postoperative days

  4. patient satisfaction

    5-point Likert scale: not at all satisfied, slightly satisfied, neutral, very satisfied and extremely satisfied

    Measured: Postoperative day 0 until 3

  5. degree of mobility

    4-point scale: on the bed (1), to the chair (2), to the toilet (3), outside the patient's hospital room(4)

    Measured: Postoperative day 0 until 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2022
  2. Study start1 Mar 2021
  3. Primary completion1 Oct 2023
  4. Study completion1 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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'.
Masking
None (open label)
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05491239
Sponsor's protocol ID
NL75375.041.20
Status last verified
Jul 2024
First submitted
2 Aug 2022
Last updated
8 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will become available for non-commercial scientific research (open access) after a period of 12 months after the last data collection. Data request can be done by contacting the PI.

Publications

  • 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.

    PubMed 40560556

  • 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.

    PubMed 36058900

Questions about this trial

What is this clinical trial studying?

A study testing Thoracic epidural analgesia, Continuous regional paravertebral block and Single shot intercostal nerve block in people with Lung Cancer and Pain, Postoperative, run by Maxima Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain scores (time frame: Postoperative day 0-2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05491239, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.

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