Needle Nerve Contact in Ultrasound Guided Femoral Block
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Purpose
Ultrasound-guided femoral nerve block is a common regional anesthesia technique. The optimal method of needle guidance (in-plane versus out-of-plane) with regards to the block efficacy and avoidance of needle-nerve contact has not been established. In this study the investigators tests the hypothesis that the incidence of needle-nerve contact is higher with the needle insertion in an out-of-plane than with the in-plane approach.
| Condition | Intervention |
|---|---|
|
Peripheral Nerve Injury |
Procedure: Needle placement |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Incidence of Intraneural Needle Insertion in Ultrasound Guided Femoral Block: Out of Plane Versus in Plane Approach |
- Number of intraneural needle insertion in ultrasound-guided femoral block: out-of-plane versus in-plane approach [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]The incidence of needle-nerve contact is higher with the out-of-plane approach (inserting the needle into the fascia at the midpoint over the femoral nerve)needle-nerve contact than with the in-plane approach (inserting the needle lateral to the femoral nerve).
- Number of Participants with femoral block success in ultrasound-guided femoral block: out-of-plane versus in-plane approach. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]The efficacy of the out-of-plane approach (inserting the needle into the fascia at the midpoint over the femoral nerve)needle-nerve contact and the in-plane approach (inserting the needle lateral to the femoral nerve).
| Estimated Enrollment: | 44 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: in plane needle placement |
Procedure: Needle placement
In plane versus out of plane needle placement techniques
|
| Experimental: out of plane needle placement |
Procedure: Needle placement
In plane versus out of plane needle placement techniques
|
Detailed Description:
Fourty-four patients with hip fracture (American Society of Anesthesiologists physical status 1-3) are being randomized to receive the femoral block with an out-of-plane (needle inserted at a 45°-60° angle 1 cm caudal to the midpoint of the ultrasound probe just above the femoral nerve) or an in-plane technique (needle inserted 0.5 cm from the side of the probe lateral to the femoral nerve). The data collected includes the depth of needle insertion at the endpoint before injection, response to nerve stimulation, distribution of the injected volume in relation to the nerve (anterior vs posterior, the latter indicating impalement), block efficacy at 20 minutes and 24 hours, and any signs of nerve injury).
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- ASA physical status 1-3 patients
- Diagnosis of trochanteric or cervical hip fracture
- Hip replacement under spinal anesthesia
Exclusion Criteria:
- Patients under the age of 65 years or over the age of 90 years
Contacts and Locations| Contact: Ana Ruiz, MD | 0034932275558 | anaruiz@clinic.ub.es |
| Contact: Xavier Sala-Blanch, MD | 0034932275558 | Xavier Sala-Blanch <xavi.sala.blanch@gmail.com> |
| United States, New York | |
| St Luke'S Roosevelt Hospital, Columbia University | Recruiting |
| New York, New York, United States, 10025 | |
| Principal Investigator: Admir Hadzic, PROF.DR | |
| Spain | |
| University of Barcelona | Recruiting |
| Barcelona, Spain | |
| Contact: Xavier Sala-Blanch, MD 0034932275558 Xavier Sala-Blanch <xavi.sala.blanch@gmail.com> | |
| Sub-Investigator: Ana Ruiz, MD | |
| Principal Investigator: Xavier Sala-Blanch, MD | |
| Sub-Investigator: Julia Martinez-Ocón, MD | |
| Sub-Investigator: Maria J Carretero, MD | |
| Sub-Investigator: Gerard Sánchez-Etayo, MD | |
| Principal Investigator: | Xavier Sala-Blanch, MD | University Clinic Barcelona |
| Principal Investigator: | Ana Ruiz, MD | University of Barcelona |
| Study Chair: | Julia Martinez-Ocon, MD | University of Barcelona |
| Study Chair: | Maria J Carretero, MD | University of Barcelona |
| Study Chair: | Gerard Sánchez-Etayo, MD | University of Barcelona |
| Study Director: | Admir Hadzic, Prof Dr | Columbia University St Luke's Hospital |
More Information
No publications provided
| Responsible Party: | Ana Ruiz, MD, Hospital Clinic of Barcelona |
| ClinicalTrials.gov Identifier: | NCT01554722 History of Changes |
| Other Study ID Numbers: | R6345 |
| Study First Received: | February 27, 2012 |
| Last Updated: | March 13, 2012 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Hospital Clinic of Barcelona:
|
Ultrasound guidance Femoral nerve block Needle placement Intraneural needle insertion |
ClinicalTrials.gov processed this record on May 21, 2013