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NCT03905837
Impact of Lidocaine Administration on Postoperative Complications During Lung Resection Surgery
Phase 4 trial testing Lidocaine in Lung Diseases in 156 participants. Completed in 2 July 2021.
2 June 2021
Quick facts
| Lead sponsor | Francisco Andres de la Gala |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 156 |
| Start date | 28 January 2019 |
| Primary completion | 2 June 2021 |
| Estimated completion | 2 July 2021 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Lidocaine — full drug profile →
- Remifentanil — full drug profile →
Conditions studied
- Lung Diseases — all drugs for Lung Diseases →
- Lung Inflammation — all drugs for Lung Inflammation →
- Lung Injury, Acute — all drugs for Lung Injury, Acute →
- Postoperative Complications — all drugs for Postoperative Complications →
Sponsor
Francisco Andres de la Gala — full company profile →
Who can join
18 and older, any sex, with Lung Diseases or Lung Inflammation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to analyze the impact of the intravenous (IV) or paravertebral (PV) lidocaine administration during the intraoperative period of lung resection surgery on the appearance of postoperative complications. We design a randomized, controlled and blinded study to be performed in 153 patients with 3 arms: 1) Lidocaine IV + PV saline 2) saline IV + PV lidocaine, 3) remifentanil IV + PV saline. Perioperative analysis of inflammatory biomarkers in bronchoalveolar lavage and serum. Follow-up of the postoperative course, especially the appearance of postoperative complications according to the revised Clavien-Dindo classification for thoracic surgery, as well as other relevant clinical results.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Effect of intraoperative paravertebral or intravenous lidocaine versus control during lung resection surgery on postoperative complications: A randomized controlled trial.
De la Gala F, Piñeiro P, Reyes A, Simón C, et al · · 2019 · cited 6× · PMID 31694684 · DOI 10.1186/s13063-019-3677-9 -
Effect of intraoperative paravertebral or intravenous lidocaine infusion on postoperative complications and inflammation after lung resection surgery: a randomised controlled trial.
de la Gala F, de la Fuente E, Piñeiro P, Reyes A, et al · · 2025 · cited 2× · PMID 40897588 · DOI 10.1016/j.bja.2025.05.059 -
Impact of Intraoperative Lidocaine During Oncologic Lung Resection on Long-Term Outcomes in Primary Lung Cancer: A Post Hoc Analysis of a Randomized Controlled Trial.
de la Fuente E, de la Gala F, Hortal J, Simón C, et al · · 2025 · cited 1× · PMID 40941021 · DOI 10.3390/cancers17172923 -
High Cerebral Oxygen Saturation Levels During One-Lung Ventilation Predict Better Cognitive and Clinical Outcomes After Thoracic Surgery: A Retrospective Observational Study.
Garutti I, de la Gala F, Hortal J, Reyes A, et al · · 2025 · PMID 41003148 · DOI 10.3390/jpm15090445
Verify or expand the search:
- PubMed search for NCT03905837
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT07355049 — The Effect of Dexmedetomidine Versus Lidocaine on Emergence Agitation. · NA · not yet recruiting
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Currently open trials in the same condition.
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Other Francisco Andres de la Gala trials
Trials by the same sponsor.
- NCT07461779 — Effect of Oxygen Administration in the Non-dependent Lung on Postoperative Complications After Lung Surgery · Phase 4 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03905837 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Francisco Andres de la Gala
- Last refreshed: 25 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03905837.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing