Clinical trial NCT01221415: A Comparison of Ultrasound and Nerve Stimulator Techniques for Nerve Localization in Regional Anesthesia
Official title: A Comparison of Ultrasound and Nerve Stimulator Techniques for Nerve Localization in Regional Anesthesia
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Orthopedic
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2010-10-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 18 years of age or older undergoing outpatient knee arthroscopy or lower leg/foot surgery as well as shoulder arthroscopy.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: time from injection of local anesthetic to adequate surgical anesthesia
timeFrame: within the first 45 minutes after injection of local anesthestic
Secondary outcomes:
measure: effectiveness of block
timeFrame: within 1 hour of injection
measure: time taken to locate the target nerve and inject local anesthetic
timeFrame: within 45 minutes prior to injection
measure: incidence of vascular puncture
timeFrame: within 30 minutes of injection
measure: incidence of adverse events
timeFrame: within 2 weeks of the day of surgery
measure: patient satisfaction
timeFrame: within 2 weeks of the date of surgery
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
Study officials:
affiliation: Ochsner Health System
name: Leslie Thomas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Domingo-Triado V, Selfa S, Martinez F, Sanchez-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):1270-4, tables of contents. doi: 10.1213/01.ane.0000221469.24319.49.
citation: Marhofer P, Schrogendorfer 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. doi: 10.1016/s1098-7339(98)90086-4.