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NCT01999647
Intraneural Injection of Ropivacaine for Subgluteal Sciatic Nerve Block Leads to Faster Onset and Higher Success Rates: a Randomized, Controlled Trial
NA trial testing Intraneural Injection for Subgluteal Sciatic Nerve Block in Orthopedic Disorders in 64 participants. Completed in 1 December 2012.
1 September 2012
Quick facts
| Lead sponsor | University of Parma |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 1 December 2011 |
| Primary completion | 1 September 2012 |
| Estimated completion | 1 December 2012 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Intraneural Injection for Subgluteal Sciatic Nerve Block
- Perineural Injection for Subgluteal Sciatic Nerve Block
- Femoral Nerve Block — full drug profile →
- Patient-Controlled Postoperative Analgesia
- Ropivacaine (ROPIVACAINE) — full drug profile →
Conditions studied
- Orthopedic Disorders — all drugs for Orthopedic Disorders →
- Foot Diseases — all drugs for Foot Diseases →
- Injuries, Leg — all drugs for Injuries, Leg →
- Injuries, Foot — all drugs for Injuries, Foot →
Sponsor
University of Parma
Who can join
18 and older, any sex, with Orthopedic Disorders or Foot Diseases. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Onset Time of Sciatic Nerve Block
Time frame: ≤30 minutes after block performance
Time to onset of sciatic nerve anesthesia, defined as both following criteria: * Sensory: does not feel pain or discomfort when pricked with a 25G needle. * Motor: able to slightly curl toes; unable to flex the ankle.
Sponsor's own description
This study was designed to assess whether the injection of local anesthetic into the nerve (intraneural), as opposed to around it (perineural), requires a shorter time to develop surgical anesthesia of the lower leg. The investigators will compare the two types of injection using the same drug, so as to determine if there is an actual difference onset time. They will also examine the overall success rate of either kind of sciatic nerve blocks as the sole anesthetic for non-emergent orthopedic surgery. The safety of these procedures will be examined by in-hospital and phone-call follow-up contacts.
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 NCT01999647
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT01999647 (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 University of Parma
- Last refreshed: 2 December 2013
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/NCT01999647.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing