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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01221415
Other study ID # 2007.127.A
Secondary ID 2007.127.A
Status Withdrawn
Phase
First received
Last updated
Start date January 2008
Est. completion date October 2011

Study information

Verified date April 2022
Source Ochsner Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective of this study is to compare ultrasound versus nerve stimulator techniques for nerve localization when performing peripheral nerve blocks. Specifically the investigators will be performing Popliteal, Femoral, and Interscalene nerve blocks. The investigators will be looking for differences in 1) time taken to locate the target nerve and inject local anesthetic 2) time from injection of local anesthetic to adequate surgical anesthesia 3) effectiveness of block 4) incidence of vascular puncture 5) incidence of adverse events 6) patient satisfaction.


Description:

After obtaining informed consent, subjects will be randomized to either the ultrasound or nerve stimulator groups as the method for nerve localization prior to peripheral block placement.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - American Society of Anesthesiologists (ASA) Physical status I-III - Arthroscopic knee surgery or Lower leg/foot surgery as well as shoulder arthroscopy - Outpatient status - Patient preference for a regional anesthetic - Subjects should be capable of giving informed consent Exclusion Criteria: - Allergy to: - Local anesthetics - Hydromorphone - Propofol - Midazolam - Patient refusal - Infection at the injection site - Peripheral Neuropathy

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Ochsner Clinic Foundation New Orleans Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Ochsner Health System

Country where clinical trial is conducted

United States, 

References & Publications (2)

Domingo-Triadó V, Selfa S, Martínez F, Sánchez-Contreras D, Reche M, Tecles J, Crespo MT, Palanca JM, Moro B. Ultrasound guidance for lateral midfemoral sciatic nerve block: a prospective, comparative, randomized study. Anesth Analg. 2007 May;104(5):1270- — View Citation

Marhofer P, Schrögendorfer K, Wallner T, Koinig H, Mayer N, Kapral S. Ultrasonographic guidance reduces the amount of local anesthetic for 3-in-1 blocks. Reg Anesth Pain Med. 1998 Nov-Dec;23(6):584-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary time from injection of local anesthetic to adequate surgical anesthesia within the first 45 minutes after injection of local anesthestic
Secondary effectiveness of block within 1 hour of injection
Secondary time taken to locate the target nerve and inject local anesthetic within 45 minutes prior to injection
Secondary incidence of vascular puncture within 30 minutes of injection
Secondary incidence of adverse events within 2 weeks of the day of surgery
Secondary patient satisfaction within 2 weeks of the date of surgery
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