Clinical trial · Interventional
Preoperative Paravertebral Block in Cancer Surgery of the Lung
Preoperative Paravertebral Block in Cancer Surgery of the Lung: ParaSOL a Prospective Randomized Controlled Clinical Trial
NCT04209868CI-TRIAL-00075545ParaSOLunknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators aim to determine whether ultrasound-guided preemptive paravertebral blockade (PVB) local anaesthetic (pre-PVB LA), administered in addition to the post-operative PVB (post-PVB) local anaesthetic (LA) infusion, reduces acute postoperative pain, opioid requirement, chronic pain, and improves surgical recovery, in thoracoscopic surgery for lung cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Post-thoracotomy Pain | — | UNRESOLVED | — |
| Anesthesia, Local | — | UNRESOLVED | — |
| Chronic Pain Post-Procedural | — | UNRESOLVED | — |
| Thoracic Neoplasm | Thoracic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 0.9% Sodium Chloride 20mL Injection | Drug | — | UNRESOLVED |
| Levo-Bupivacaine Hydrochloride (HCl) 0.5 % in 20mL Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Pre-PVB with saline
- description
- Placebo (20ml Saline) pre-PVB performed post-induction and pre-incision.
- interventionNames
- Drug: 0.9% Sodium Chloride 20mL Injection
- type
- EXPERIMENTAL
- label
- Pre-PVB with 0.5% Levo-bupivacaine
- description
- 20ml 0.5% Levo-bupivacaine pre-PVB performed post-induction and pre-incision.
- interventionNames
- Drug: Levo-Bupivacaine Hydrochloride (HCl) 0.5 % in 20mL Injection
Primary outcomes (1)
- measure
- Moderate-to-severe pain Numerical Rating Scale (NRS) >/=3
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Elective radical primary lung cancer VATS surgery for single lobectomy * American Society of Anesthesiology (ASA) I-III * Age ≥18 Exclusion Criteria: * Planned open thoracotomy, wedge resection, bilobectomy, pneumonectomy, chest wall resection or total pleurectomy * Local anaesthetic or opioid allergy * Coagulation disorders * Inability to comply with study questionnaire completion * Pre-existing pain in chest area or pre-existing pain conditions * Local infection/tumour at proposed PVB site * Previous lung surgery * Planned surgery within 3 months of the primary lung resection
References
Publications (0)
Data not yet available
No reference posted for this study.