A Comparison of Ultrasound and Nerve Stimulator Techniques for Nerve Localization in Regional Anesthesia

NCT01221415 | Withdrawn DMC

• 1 other identifier: 2007.127.A
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic

Outcome Measures

Primary Outcomes (1)

• time from injection of local anesthetic to adequate surgical anesthesia

  within the first 45 minutes after injection of local anesthestic

Secondary Outcomes (5)

• effectiveness of block

  within 1 hour of injection

• time taken to locate the target nerve and inject local anesthetic

  within 45 minutes prior to injection

• incidence of vascular puncture

  within 30 minutes of injection

• incidence of adverse events

  within 2 weeks of the day of surgery

• patient satisfaction

  within 2 weeks of the date of surgery

Study Arms (6)

Interscalene Ultrasound

Subjects having orthopedic surgery requiring an interscalene peripheral nerve block and randomized to have the ultrasound used to locate the nerve.

Interscalene Nerve Stimulator

Subjects having orthopedic surgery requiring an interscalene peripheral nerve block and randomized to have the nerve stimulator used to locate the nerve.

Popliteal Ultrasound

Subjects having orthopedic surgery requiring an popliteal peripheral nerve block and randomized to have the ultrasound used to locate the nerve.

Popliteal Nerve Stimulator

Subjects having orthopedic surgery requiring an popliteal peripheral nerve block and randomized to have the nerve stimulator used to locate the nerve.

Femoral Ultrasound

Subjects having orthopedic surgery requiring an femoral peripheral nerve block and randomized to have the ultrasound used to locate the nerve.

Femoral Nerve Stimulator

Subjects having orthopedic surgery requiring an femoral peripheral nerve block and randomized to have the nerve stimulator used to locate the nerve.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Allergy to:
• Local anesthetics
• Hydromorphone
• Propofol
• Midazolam
• Patient refusal
• Infection at the injection site
• Peripheral Neuropathy

Sponsors & Collaborators

• Ochsner Health System: lead

Study Sites (1)

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Related Publications (2)

• 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.

  PMID: 17456685 RESULT

• 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.

  PMID: 9840855 RESULT

Study Officials

• Leslie Thomas, MD

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: October 15, 2010
• Study Start: January 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

US (1)