Pain after lung cancer surgery – comparing traditional versus prolonged release nerve blockades

Pain after thoracoscopic lung surgery – the effect of intercostal nerve blockades with standard bupivacaine and liposomal bupivacaine – a randomised controlled feasibility trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003218-38-DK

Enrollment

Registered

2021-07-02

Start date

2021-09-08

Completion date

Unknown

Last updated

2024-11-04

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

Conditions

Acute postoperative pain Lung cancer MedDRA version: 20.0 Level: LLT Classification code 10025044 Term: Lung cancer System Organ Class: 100000004864

Interventions

Trade Name: Exparel Product Name: Exparel Pharmaceutical Form: Solution for injection in vial INN or Proposed INN: Bupivacaine CAS Number: 2180-92-9 Concentration unit: mg/ml milligram(s)/millilitre C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults independent of sex with an age of = 18 years Patients undergoing VATS as a part of either examination or radical treatment of lung cancer 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

Exclusion criteria: Patients who are unable to understand oral and written information. Patients with known chronic pain in the thorax which have been persisting for at least six months before the day of surgery. Pregnant and nursing women. Patients with hypersensitivity / allergy / Intolerance to dexamethasone or bupivacaine. Patients receiving a planned preoperative epidural blockade during their stay. Patients converted to open surgery

Design outcomes

Primary

Measure	Time frame
Main Objective: To examine if intercostal nerve blockades with liposomal bupivacaine improves postoperative pain management compared to intercostal nerve blockades with bupivacaine HCL. ;Secondary Objective: Not applicable.;Primary end point(s): Time to first postoperative administration of Pro Re Nata (PRN) opioids. ;Timepoint(s) of evaluation of this end point: Hours	—

Secondary

Measure	Time frame
Secondary end point(s): 1. Total equipotent opioid dose in milligrams during the first 48 hours after surgery. 2. Pain intensity on a Numerical Rating Scale ranging from 0 indicating no pain to 10 indicating worst pain imaginable during the first two postoperative days. 3. Time to full mobilisation defined as walking with or without aids. 4. Need for opioids (yes or no and equipotent dosage) 5. Patient-reported satisfaction of postoperative pain management;Timepoint(s) of evaluation of this end point: 1. 48 hours after surgery 2. The evening following surgery, then 2 times daily the first 48 hours. 3. Hours 4. At discharge 5. At discharge or at 48 hours after surgery if still admitted	—

Measure

Time frame

Secondary end point(s): 1. Total equipotent opioid dose in milligrams during the first 48 hours after surgery. 2. Pain intensity on a Numerical Rating Scale ranging from 0 indicating no pain to 10 indicating worst pain imaginable during the first two postoperative days. 3. Time to full mobilisation defined as walking with or without aids. 4. Need for opioids (yes or no and equipotent dosage) 5. Patient-reported satisfaction of postoperative pain management;Timepoint(s) of evaluation of this end point: 1. 48 hours after surgery 2. The evening following surgery, then 2 times daily the first 48 hours. 3. Hours 4. At discharge 5. At discharge or at 48 hours after surgery if still admitted

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Countries

Denmark

Contacts

Public Contactj.staehr@rn.dk

Aalborg University Hospital

j.staehr@rn.dk+4597660578

Outcome results

None listed

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