Ultrasound Visualization Versus Electrical Nerve Stimulation

This study has been completed.
Sponsor:
Collaborator:
SonoSite, Inc.
Information provided by (Responsible Party):
Nanette Schwann, M.D., Allentown Anesthesia Associates
ClinicalTrials.gov Identifier:
NCT01010412
First received: November 9, 2009
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

Hypothesis and Specific Aims:

The investigators hypothesize that ultrasound (US) visualization is as effective as nerve stimulation (NS) for identification of peripheral nervous structures and may be associated with less trauma and patient discomfort. Specifically, the investigators believe that equivalent rates of surgical anesthesia are achievable with non-invasive ultrasonic needle guidance in comparison to needle guidance by intensity of motor fiber response to intermittent electrical nerve stimulation. Specifically, the number of needle sticks to identify the brachial plexus and total time to plexus sheath injection may be reduced while achieving similar efficacy rates. The investigators hypothesize that similar composite safety and efficacy endpoints but improved patient satisfaction and acceptance will favor US over NS guidance of nerve blocks indicated for surgery on the extremity surgery. However, the investigators believe that an economic assessment based upon capital hardware investment, operating room utilization, total block time, and pay for performance patient satisfaction metrics require examination prior to assimilation of new technology into clinical practice.


Condition Intervention Phase
Trauma to the Arm, Shoulder, Elbow, Forearm, or Hand
Device: Ultrasound (Sonosite Titan T-shaped ultrasound probe)
Device: Electrical Nerve Stimulation (Stimuplex (B Braun) needle)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Ultrasound Visualization v. Electrical Nerve Stimulation for the Safety and Effectiveness of Interscalene/Axillary Nerve Block in Upper Extremity Surgery: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Allentown Anesthesia Associates:

Primary Outcome Measures:
  • Incidence of Successful Block: defined by avoidance of General Anesthesia (which will be documented in the medical record as such) [ Time Frame: 30 minutes after injection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Amount of sedation required for block. (mg of drug) [ Time Frame: 30 minutes after injection ] [ Designated as safety issue: Yes ]

Enrollment: 158
Study Start Date: February 2009
Study Completion Date: October 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasound
Ultrasound guided nerve localization through direct visualization of the nerves and surrounding structures.
Device: Ultrasound (Sonosite Titan T-shaped ultrasound probe)
Ultrasonography will allow direct visualization of nerves. As local anesthetic is injected, it can be seen surrounding the nerve.
Other Name: Sonosite Titan T-shaped ultrasound probe
Active Comparator: Nerve Stimulation
Standard of Care
Device: Electrical Nerve Stimulation (Stimuplex (B Braun) needle)

  Hide Detailed Description

Detailed Description:

This is a prospective randomized study of 450 consecutive patients presenting for upper extremity surgery scheduled to receive NB without general anesthesia for their surgical procedure. Patients will be randomized to receive one of two nerve localization techniques in a 1:1 randomization ratio. Primary intraoperative providers of supplemental sedative, additional local anesthetic infiltration or analgesia, general anesthesia and assessors of VAS or PCI will be blinded to the technique.

Patients over 18 years of age presenting for elective upper extremity surgery planned in the supine position under isolated interscalene or axillary nerve block will be screened. Up to 450 patients undergoing unilateral upper extremity procedures at Lehigh Valley Hospital will be enrolled.

STUDY PROCEDURES Screening:

All patients meeting inclusion criteria and not meeting exclusion criteria will be eligible to be enrolled. All subjects who have preadmission testing will be recruited prior to their surgical procedure with initial contact made before the day of their scheduled surgery. For patients who do not have preadmission testing scheduled and are found to be eligible for the study on the day of surgery, those patients will be consented for the study the morning of their procedure by the study anesthesiologist. Only patients who are able to understand English and who are able to legally give written informed consent will be recruited to the study. Following signed informed consent (IRB approved) and permission of their surgeon and anesthesiologist and prior to the start of anesthesia, vital signs, standard lab tests, patient history and physical examination will be reviewed.

Day of Procedure:

For the NS group, interscalene/axillary block will be performed in the standard method using a nerve stimulator attached to a four centimeter Stimuplex (B Braun) needle. Following application of routine monitors, supplemental oxygen via facemask, and intravenous sedation, the skin overlying the brachial plexus will be anesthetized. The Stimuplex needle will then be inserted and guided into a position in close proximity to the brachial plexus using an endpoint of muscle twitches involving the hand at a stimulus intensity of less than 0.5 milliamps to the satisfaction of the operator. Forty (40) milliliters of 0.5 percent Bupivicaine with 1.5% Mepivicaine with 1:200,00 of epinephrine will be injected incrementally with intermittent aspiration. This block is chosen for the study because of its widespread use for a variety of shoulder procedures and for its low incidence of complications. The quoted success rate in the literature for interscalene block ranges from 70 to 95 percent.

For the US group interscalene block will be performed in a method using ultrasound guided needle insertion. Following application of routine monitors, supplemental oxygen via facemask, and intravenous sedation, the skin overlying the brachial plexus will be anesthetized. A sterile cover will be used for the ultrasound probe. Using this probe, the anesthesiologist can visualize the nerve and will maneuver the tip of the needle into the nerve guided by the of ultrasound probe. Forty (40) milliliters of 0.5% Bupivicaine with 1.5% Mepivicaine with 1:200,00 of Epinephrine will be injected incrementally with intermittent aspiration. This block is chosen for the study because of its widespread use for a variety of shoulder procedures and for its low incidence of complications. The quoted success rate in the literature for interscalene block ranges for 70 to 95 percent.

The brachial plexus will be visualized at the level of the roots of the plexus at this level. Presence or absence of local anesthetic around the nerves will be recorded using a Sonosite Titan T-shaped ultrasound probe placed on the patient's skin. Still images of the brachial plexus and the local anesthetic will be captured for each patient. Patient identifiers will be on the images, however the images are placed on the patient's medical record.

Assessment of block success:

The success of the block will be assessed by examining motor strength in the anesthetized extremity and degree of anesthesia at 30 minutes after injection. Strength in the distribution of the musculocutaneous, median, radial, and ulnar nerves will be assessed. Pinprick and cold sensation will be assessed in the same distributions. A successful block will be one with a lack of sensation to cold and pinprick in the above distributions as well as strength less than three out of five on the standard scale of strength testing in all of the above distributions. Ultimately, block success (yes/no) will be determined by pain free surgery not requiring general anesthesia. The patient comfort index and post op assessments will be carried out as above.

Completion of the Study:

The study will be complete at PACU discharge after the patient returns his/her assessment of PCI and pain and nausea data.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients older than 18 years of age at the time of screening
  • ASA Class I - IV, undergoing unilateral elective surgical procedure involving the shoulder, arm, elbow, forearm, or hand
  • Planned interscalene block

Exclusion Criteria:

  • Peripheral neuropathy
  • Coagulopathy
  • Anticoagulant treatment that would preclude regional anesthesia
  • Local anesthetic allergy
  • Infection at the site of injection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010412

Locations
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
Sponsors and Collaborators
Allentown Anesthesia Associates
SonoSite, Inc.
Investigators
Principal Investigator: Nanette Schwann, M.D. Allentown Anesthesia Associates
  More Information

Publications:
Responsible Party: Nanette Schwann, M.D., MD, Allentown Anesthesia Associates
ClinicalTrials.gov Identifier: NCT01010412     History of Changes
Other Study ID Numbers: UVVENS
Study First Received: November 9, 2009
Last Updated: August 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Allentown Anesthesia Associates:
Ultrasound
Nerve blocks
Upper extremity

ClinicalTrials.gov processed this record on August 28, 2014