Levobupivacaine
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Levobupivacaine: From Local Anaesthesia to Gastroduodenitis
One-Sentence Summary
Levobupivacaine is a long-acting amide local anaesthetic that blocks voltage-gated sodium channels. The TxGNN model ranks gastroduodenitis as its top predicted new indication, but no clinical trials and no publications currently support this prediction. The score is a graph-based computational prediction only (evidence level L5).
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the registration record (local anaesthesia/analgesia by injection is the known use) |
| Predicted New Indication | Gastroduodenitis |
| TxGNN Prediction Score | 99.09% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on known information, levobupivacaine is a long-acting amide local anaesthetic, and it is understood to act by blocking voltage-gated sodium channels in nerve fibres. Its anaesthetic and analgesic efficacy is established, but this does not extend to inflammatory gastrointestinal disease.
For gastroduodenitis, no mechanistic link could be identified. Sodium channel blockade has no established role in gastroduodenal inflammation, and the high TxGNN score reflects graph-based association only. The same applies to the other top-ranked predictions (peptic ulcer disease, gout, rhinitis, bronchitis, ankylosing spondylitis), none of which has any trial or literature support.
Other predictions with some evidence
- Migraine disorder (score 97.59%, L4): Local anaesthetics are used in greater occipital nerve blocks, which plausibly modulate headache pain signalling. The single 2026 publication is a prospective cohort on nerve blocks across headache types. It does not isolate levobupivacaine. This is indirect procedural evidence, not evidence for systemic repurposing.
- Hypertensive disorder (score 96.19%, L4): The studies use levobupivacaine as an anaesthetic in hypertensive or haemodynamically sensitive patients. They do not show that it treats hypertension.
- Exostosis (score 96.76%, L4): One case report describes routine perioperative nerve block analgesia, not treatment of the disease.
Clinical Trial Evidence
Currently no related clinical trials are registered for gastroduodenitis, the top-ranked prediction.
For reference, the two trials found for the lower-ranked prediction of hypertensive disorder are anaesthesia studies, not disease-treatment studies:
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT02699827 | Phase 4 | Completed | 60 | Magnesium sulphate added to epidural levobupivacaine for caesarean section in preeclampsia; endpoint is anaesthesia quality and pain relief |
| NCT02497040 | Phase 4 | Completed | 90 | Scalp block with bupivacaine vs levobupivacaine on the haemodynamic response to head pinning; indirect relevance |
Literature Evidence
Currently no related literature is available for gastroduodenitis.
For reference, selected publications for lower-ranked predictions (all indirect):
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 28415943 | 2017 | RCT | J Int Med Res | Scalp block with bupivacaine vs levobupivacaine: haemodynamic response and postoperative analgesia (publication of NCT02497040) |
| 26894153 | 2016 | RCT | J Clin Diagn Res | Epidural bupivacaine, levobupivacaine and dexmedetomidine in vascular surgery patients |
| 30417244 | 2019 | Review | J Anesth | Practical guide to managing local anaesthetic systemic toxicity |
| 24258467 | 2014 | Observational | J Anesth | Ultrasound vs neurostimulation technique and hypertension after interscalene block |
| 42533183 | 2026 | Cohort (likely) | Pain Ther | Greater occipital nerve block across headache phenotypes (migraine) |
| 36344405 | 2022 | Case report | Rev Esp Anestesiol Reanim | Costoclavicular brachial plexus block with 0.25% levobupivacaine in a child with multiple exostoses |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN16641P | L-ASCAIN SOLUTION FOR INJECTION 5MG/ML | Injection, solution | Not stated in the record |
Safety Considerations
- Disease associations flagged in the knowledge graph (not label text): kidney disease, pyoureter, liver disease, gallbladder disease, myasthenia gravis (including adult-onset), neuromuscular junction disease, butyrylcholinesterase deficiency, cardiovascular disease, and heart disease.
- Drug Interactions: 62 interactions were recorded. Examples at Moderate level include aprepitant, cimetidine, clarithromycin, obeticholic acid, miconazole, clotrimazole, cobicistat, deferasirox, ticlopidine, fostamatinib, thiabendazole, primaquine, and other topical or ophthalmic local anaesthetics (lidocaine, benzocaine, cocaine). Minor interactions include dexamethasone, omeprazole, hyaluronidase, and albendazole.
- Class note: Systemic toxicity of local anaesthetics (central nervous system and cardiovascular) is a recognised risk, and it matters for any use beyond routine anaesthesia.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The top prediction, gastroduodenitis, rests on a model score alone. There are no trials or publications, and no plausible mechanism links sodium channel blockade to gastroduodenal inflammation. Migraine (nerve-block procedures) is the only prediction with a plausible link, and that evidence is indirect and does not isolate levobupivacaine.
To proceed, the following is needed:
- Package insert warnings and contraindications from the HSA record (safety screening cannot proceed without them)
- Approved indication text for the Singapore registration
- Mechanism of action data
- For migraine as a research question: studies that specifically use levobupivacaine in nerve blocks for headache
- Route compatibility assessment: the only registered form is an injectable, and the predicted indications have not been checked against it
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.