drugset / Trial / NCT04169854
Pre-emptive Topical Lidocaine 5% Plaster for Prevention of Post-craniotomy Pain
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Postcraniotomy pain remains a common phenomenon in the neurosurgery field. Managements for postcraniotomy pain are to be standardised and optimized. In the proposed study, the investigators aim to provide a novel regional non-invasive prophylactic strategy for postcraniotomy pain by utilizing Lidocaine 5% plaster.
Timeline
- Start
- 2020-10-15
- Primary completion
- 2023-01
- Completion
- 2023-01
Outcome
Missed primary endpoint
paper There were no statistically significant differences in the VAS scores at 24 h after craniotomy (P = 0.539). PMID 39691748 ↗
Publications
- Background Gottschalk A, Berkow LC, Stevens RD, Mirski M, Thompson RE, White ED, Weingart JD, Long DM, Yaster M. Prospective evaluation of pain and analgesic use following major elective intracranial surgery. J Neurosurg. 2007 Feb;106(2):210-6. doi: 10.3171/jns.2007.106.2.210.
- Background Mordhorst C, Latz B, Kerz T, Wisser G, Schmidt A, Schneider A, Jahn-Eimermacher A, Werner C, Engelhard K. Prospective assessment of postoperative pain after craniotomy. J Neurosurg Anesthesiol. 2010 Jul;22(3):202-6. doi: 10.1097/ANA.0b013e3181df0600.
- Background Artime CA, Aijazi H, Zhang H, Syed T, Cai C, Gumbert SD, Ferrario L, Normand KC, Williams GW, Hagberg CA. Scheduled Intravenous Acetaminophen Improves Patient Satisfaction With Postcraniotomy Pain Management: A Prospective, Randomized, Placebo-controlled, Double-blind Study. J Neurosurg Anesthesiol. 2018 Jul;30(3):231-236. doi: 10.1097/ANA.0000000000000461.
- Background Licina A, Russell J, Silvers A, Jin X, Denny J. Subcutaneous sumatriptan for the treatment of postcraniotomy pain (SUPS trial): protocol for a randomised double-blinded placebo controlled trial. BMJ Open. 2019 Aug 18;9(8):e032388. doi: 10.1136/bmjopen-2019-032388.
- Background Hassani E, Mahoori A, Sane S, Tolumehr A. Comparison the effects of paracetamol with sufentanil infusion on postoperative pain control after craniotomy in patients with brain tumor. Adv Biomed Res. 2015 Mar 4;4:64. doi: 10.4103/2277-9175.152610. eCollection 2015.
- Han X, Yang Y, Ren T, Ji N, Luo F. Efficacy of Preemptive Topical Lidocaine 5% Plaster in the Prevention of Post-Craniotomy Pain, a Randomized Clinical Trial. J Pain Res. 2024 Dec 13;17:4251-4261. doi: 10.2147/JPR.S499264. eCollection 2024.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lidocaine | Other / unclassified | 5 % | Topical |
Indications
No indication recorded.