Optimal pain management after a lung operation

Optimal postoperative Pain management After Lung surgery (OPtriAL): multi-centre randomised trial - OPtriAL

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004584-11-NL

Enrollment

571

Registered

2020-12-24

Start date

2021-02-03

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute postoperative pain after lung surgery MedDRA version: 20.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863

Interventions

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Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients referred for anatomical lung resection (pneumonectomy, (bi)lobectomy or segmentectomy) with the intention of performing it by VATS or RATS are eligible for the trial. Adult patients older than 18 years who are able to give informed consent and fill out questionnaires in Dutch. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 171

Exclusion criteria

Exclusion criteria: Patients with contra-indications for TEA or PVB (infection at skin site, increased intracranial pressure, non-correctable coagulopathy, 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. If, prior to the procedure, catheter placement during TEA is unsuccessful, a continuous PVB will be given during the procedure, and, if catheter placement during PVB is unsuccessful, a single shot multilevel ICNB will be used. Non-inferiority will be analysed based on intention-to-treat, as well as per-protocol analysis. In case the lung surgeon estimates the operation to be performed through a thoracotomy technique instead of a VATS the patient will be excluded.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: not applicable ;Timepoint(s) of evaluation of this end point: 4 weeks;Main Objective: The main objective is to compare regional continuous paravertebral block (PVB), single shot multi-level intercostal nerve block (ICNB) and thoracic epidural analgesia (TEA) as pain relief techniques in order to provide safe, effective and efficient pain management after thoracoscopic lung surgery. This study will provide the evidence for an ERATS protocol to be implemented for the optimal analgesic technique after VATS anatomic lung resection taking into account pain scores and QoR.;Primary end point(s): The NRS (0-10; 0= no pain, 10=worst imaginable pain) will be used to measure pain scores. The primary outcome measure for ‘non-inferiority’ is the proportion of NRS =4, defined as the number of NRS =4 episodes divided by the total amount of NRS pain scores obtained. A minimum of 11 NRS pain scores will be collected (at the recovery room (1), on the ward (10)). The primary outcome for ‘superiority’ is QoR measured with the QoR-15 questionnaire on POD 1 and POD 2. The QoR-15 will provide a continuous variable with a minimum score of 0 and maximum score of 150, and contains the most relevant questions concerning 5 domains (emotional status, physical comfort, psychological support, physical independence and pain) of overall well-being and recovery after surgery.	—

Measure

Time frame

Secondary Objective: not applicable ;Timepoint(s) of evaluation of this end point: 4 weeks;Main Objective: The main objective is to compare regional continuous paravertebral block (PVB), single shot multi-level intercostal nerve block (ICNB) and thoracic epidural analgesia (TEA) as pain relief techniques in order to provide safe, effective and efficient pain management after thoracoscopic lung surgery. This study will provide the evidence for an ERATS protocol to be implemented for the optimal analgesic technique after VATS anatomic lung resection taking into account pain scores and QoR.;Primary end point(s): The NRS (0-10; 0= no pain, 10=worst imaginable pain) will be used to measure pain scores. The primary outcome measure for ‘non-inferiority’ is the proportion of NRS =4, defined as the number of NRS =4 episodes divided by the total amount of NRS pain scores obtained. A minimum of 11 NRS pain scores will be collected (at the recovery room (1), on the ward (10)). The primary outcome for ‘superiority’ is QoR measured with the QoR-15 questionnaire on POD 1 and POD 2. The QoR-15 will provide a continuous variable with a minimum score of 0 and maximum score of 150, and contains the most relevant questions concerning 5 domains (emotional status, physical comfort, psychological support, physical independence and pain) of overall well-being and recovery after surgery.

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Secondary

Measure	Time frame
Secondary end point(s): 1) Pain scores during rest and mobilisation at baseline, in the morning, afternoon and evening on POD 0-3 and at 2-3 weeks follow-up; 2) Proportion of postoperative pain scores of NRS =4 during mobilization at POD 0-3; 3) QoR-15 pre-operatively (baseline), POD 0, POD 3 and at 2-3 weeks follow-up; 4) Cumulative use of systemic opioids and analgesics at POD 0-3; 5) Postoperative complications until 2-3 weeks follow-up, according to the Clavien-Dindo classification; 6) Hospitalization, 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. 7) Patient satisfaction (5-point Likert scale: not at all satisfied, slightly satisfied, neutral, very satisfied and extremely satisfied); 8) Degree of mobility (1-4 scale: on the bed (1), to the chair (2), to the toilet (3), outside the patient’s hospital room(4)); ;Timepoint(s) of evaluation of this end point: 4 weeks	—

Measure

Time frame

Secondary end point(s): 1) Pain scores during rest and mobilisation at baseline, in the morning, afternoon and evening on POD 0-3 and at 2-3 weeks follow-up; 2) Proportion of postoperative pain scores of NRS =4 during mobilization at POD 0-3; 3) QoR-15 pre-operatively (baseline), POD 0, POD 3 and at 2-3 weeks follow-up; 4) Cumulative use of systemic opioids and analgesics at POD 0-3; 5) Postoperative complications until 2-3 weeks follow-up, according to the Clavien-Dindo classification; 6) Hospitalization, 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. 7) Patient satisfaction (5-point Likert scale: not at all satisfied, slightly satisfied, neutral, very satisfied and extremely satisfied); 8) Degree of mobility (1-4 scale: on the bed (1), to the chair (2), to the toilet (3), outside the patient’s hospital room(4)); ;Timepoint(s) of evaluation of this end point: 4 weeks

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Countries

Netherlands

Contacts

Public ContactLouisa Spaans

Maxima MC

louisa.spaans@mmc.nl310408887243

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026