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NCT03599427
Added Value of Systemic Lidocaine on Postoperative Pain, Opiate Use and Nausea After Knee Arthroscopy
Phase 4 trial testing systemic lidocaine in Surgery in 60 participants. Completed in 30 June 2019.
1 June 2019
Quick facts
| Lead sponsor | Algemeen Ziekenhuis Maria Middelares |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | supportive care |
| Enrollment | 60 |
| Start date | 1 September 2018 |
| Primary completion | 1 June 2019 |
| Estimated completion | 30 June 2019 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- systemic lidocaine — full drug profile →
- Placebo
Conditions studied
- Surgery — all drugs for Surgery →
- Pain, Postoperative — all drugs for Pain, Postoperative →
- Nausea, Postoperative — all drugs for Nausea, Postoperative →
- Opioid Use — all drugs for Opioid Use →
Sponsor
Algemeen Ziekenhuis Maria Middelares — full company profile →
Who can join
18 and older, any sex, with Surgery or Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Local intra-articular injection of anesthetics (LIA) is increasingly used during knee arthroscopy for pain relief. The LIA can only be performed at the end of surgery as the knee joint is continuously flushed during the arthroscopy. As a consequence, an optimal analgesic effect is only obtained one hour after surgery and opiates are typically used as pain relief in the immediate postoperative period. Since these opiates have a number of side effects such as nausea, vomiting and drowsiness, other analgetic methods are desirable. Intravenous administration of lidocaine, a safe, inexpensive analgesic, is already used in major (abdominal) surgeries and might also be a promising method for pain relief in the first hour after knee arthroscopy, in anticipation of the onset of the analgesic effect of the LIA. The aim of this study is to verify if systemic administration of lidocaine has a beneficial effect on the pain immediately after knee arthroscopy. In addition, the effect of systemic lidocaine administration on postoperative nausea, vomiting and general patient comfort will be evaluated.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03599427
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Algemeen Ziekenhuis Maria Middelares trials
Trials by the same sponsor.
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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 NCT03599427 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Algemeen Ziekenhuis Maria Middelares
- Last refreshed: 10 October 2019
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/NCT03599427.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing