N/A
N=250
Ultrasound Guided Distal Sciatic Nerve Block - a Comparison With Nerve Stimulator Technique
Other Surgical Procedures
Bottom Line
View on ClinicalTrials.gov: NCT01643616 ↗Enrolled (actual)
250
Serious AEs
0.4%
Results posted
Nov 2013
Primary outcome: Primary: Success Rate Without Supplementation — 112; 73 participants — p=< 0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- midazolam (Drug); Prilocaine 1% (Drug); Ropivacaine 0.75% (Drug); ultrasound guidance (Device); nerve stimulation technique (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Helios Research Center
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success Rate Without Supplementation |
112; 73 | < 0.05 sig |
| PRIMARY Time Until Readiness for Surgery (Minutes) |
15.1; 28 | < 0.05 sig |
| PRIMARY Success Rate With Supplementation |
116; 85 | 0.05 |
Summary
For distal sciatic nerve block this prospective, randomised comparison with ultrasound guided distal subepineural block tested the hypothesis, that intraepineural injection of local anesthetic using nerve stimulation technique is common and associated with high success rate.
Eligibility Criteria
Inclusion Criteria
- elective surgery on the foot or ankle
- tourniquet distal of the knee
- adult patients, 18-75 years old
- ASA-risk-groups I-III (American Society of Anesthesiologists)
- informed consent
Exclusion Criteria
- severe coagulopathy
- systemic inflammatory response
- ASA-risk-groups > III (American Society of Anesthesiologists)
- drug allergy: local anesthetics
- pregnancy, lactation period
- participation in other studies
- addiction to drugs or alcohol
- non-cooperative patients
Data sourced from ClinicalTrials.gov (NCT01643616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.