N/A
N=80
Saphenous Nerve Block for Foot and Ankle Surgery
Saphenous Nerve Block
Bottom Line
View on ClinicalTrials.gov: NCT02382744 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Block Success — 18; 22 participants — p=0.25
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ultrasound Guidance (Device); Ultrasound guidance + nerve stimulation (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of British Columbia
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Block Success |
18; 22 | 0.25 |
| SECONDARY Block Failure Rate |
1; 3; 39; 37 | 0.62 |
| SECONDARY Any Evidence of Blockade (Decreased or Complete Absence of Sensation) |
39; 37 | 0.62 |
| SECONDARY Incomplete Block Rate |
21; 15; 19; 25 | 0.26 |
| SECONDARY Speed of Onset for Nerve Block (Complete Blockade) |
25.0; 17.5 | 0.12 |
| SECONDARY Rate of Success of Elicitation of a Tapping Sensation |
32 | — |
| SECONDARY Mean Minimum Stimulation Current |
0.39 | — |
| SECONDARY Rate of Success of Elicitation of a Tapping Sensation at < 0.6 Milliampere (mA) |
25 | — |
| SECONDARY Time Required to Administer Block |
207; 314 | <0.0001 sig |
| SECONDARY Immediate Complications |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Delayed Complications |
0; 1; 0; 0 | — |
Summary
Patients undergoing foot and ankle surgery have the option of having a nerve block administered by their Anesthesiologist. The nerve block numbs the foot and results in less post-operative nausea and vomiting, and better pain control. Two different techniques for blocking the saphenous nerve to the foot have been described and are both commonly used at St. Paul's hospital. The goal of this study is to compare the success rates of these two techniques.
Eligibility Criteria
Inclusion Criteria
- Subjects undergoing foot and ankle surgery
- Aged 19-80
- Normal sensation in saphenous nerve distribution in both legs
- Provided written informed consent.
- Body Mass Index <38 kg/m2
Exclusion Criteria
- Subject refusal
- A known history of allergy, sensitivity or any other form of reaction to local anesthetics of amide type
- Suspected inability to comply with study procedures, including language difficulties or medical history and/or concomitant disease (i.e. skin infection as the site of needle insertion), as judged by the investigator. Reason for exclusion will be recorded.
- A neurological and/or vascular condition, which may preclude eligibility for peripheral nerve blockade (i.e. peripheral neuropathy) as judged by the investigator. Reason for exclusion will be recorded.
- Subjects on therapeutic anticoagulation or coagulopathy at the time of nerve blockade.
- Previous inclusion in this study.
- Participation in other clinical studies during this study or in the 14 days prior to admission to this study.
- Surgeon refusal (e.g. the surgeon does not want a nerve block for the subject). Reason for exclusion will be recorded.
Data sourced from ClinicalTrials.gov (NCT02382744). 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.