Trauma to the Arm, Shoulder, Elbow, Forearm, or HandPhase 4NCT01010412
Ultrasound Visualization Versus Electrical Nerve Stimulation
A Phase 4 study testing Ultrasound (Sonosite Titan T-shaped ultrasound probe) and Electrical Nerve Stimulation (Stimuplex (B Braun) needle) in people with Trauma to the Arm, Shoulder, Elbow, Forearm, or Hand, run by Allentown Anesthesia Associates at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma to the Arm, Shoulder, Elbow, Forearm, or Hand
- What is being tested?
- Ultrasound (Sonosite Titan T-shaped ultrasound probe) and Electrical Nerve Stimulation (Stimuplex (B Braun) needle)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Oct 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Peripheral neuropathy
- Coagulopathy
- Anticoagulant treatment that would preclude regional anesthesia
- Local anesthetic allergy
- Infection at the site of injection
Trial locations and contacts
1 site in 1 country.
United States1 site
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105
About this study
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
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.
Read the 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.
- Being tested
- Ultrasound (Sonosite Titan T-shaped ultrasound probe), Electrical Nerve Stimulation (Stimuplex (B Braun) needle)
- Keywords
- Ultrasound, Nerve blocks, Upper extremity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound (Sonosite Titan T-shaped ultrasound probe)Device
Also called 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.
Electrical Nerve Stimulation (Stimuplex (B Braun) needle)Device
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Ultrasound guided nerve localization through direct visualization of the nerves and surrounding structures. Receives: Device: Ultrasound (Sonosite Titan T-shaped ultrasound probe) |
| Nerve Stimulation | Active comparator | Standard of Care Receives: Device: Electrical Nerve Stimulation (Stimuplex (B Braun) needle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Successful Block: defined by avoidance of General Anesthesia (which will be documented in the medical record as such)
Measured: 30 minutes after injection
Secondary outcomes (1)
Amount of sedation required for block. (mg of drug)
Measured: 30 minutes after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trauma to the Arm, Shoulder, Elbow, Forearm, or HandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allentown Anesthesia Associates
- Sponsor type
- University, hospital or other
- Collaborators
- SonoSite, Inc.
- Responsible party
- Principal investigator, Nanette Schwann, M.D., Allentown Anesthesia Associates
- Investigators
- Nanette Schwann, M.D., Principal investigator, Allentown Anesthesia Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010412
- Sponsor's protocol ID
- UVVENS
- Status last verified
- Aug 2012
- First submitted
- 9 Nov 2009
- Last updated
- 30 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Gray AT, Schafhalter-Zoppoth I. Ultrasound guidance for ulnar nerve block in the forearm. Reg Anesth Pain Med. 2003 Jul-Aug;28(4):335-9. doi: 10.1016/s1098-7339(03)00196-2.
PubMed 12945028
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01010412
- Acronym / sponsor ID
- UVVENS
- Keywords
- Ultrasound, Nerve blocks, Upper extremity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Allentown Anesthesia AssociatesUniversity, hospital or other
- Collaborators
- SonoSite, Inc.
- Study start
- Feb 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Device: Ultrasound (Sonosite Titan T-shaped ultrasound probe)Ultrasound guided nerve localization through direct visualization of the nerves and surrounding structures. |
| Nerve Stimulation | Active comparator | Device: Electrical Nerve Stimulation (Stimuplex (B Braun) needle)Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Peripheral neuropathy
- Coagulopathy
- Anticoagulant treatment that would preclude regional anesthesia
- Local anesthetic allergy
- Infection at the site of injection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound (Sonosite Titan T-shaped ultrasound probe)Also: Sonosite Titan T-shaped ultrasound probeUltrasonography will allow direct visualization of nerves. As local anesthetic is injected, it can be seen surrounding the nerve. | Device | Ultrasound |
| Electrical Nerve Stimulation (Stimuplex (B Braun) needle) | Device | Nerve Stimulation |
Primary outcome
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
1 secondary outcome
Amount of sedation required for block. (mg of drug)
Time frame: 30 minutes after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2012.
- Background: PubMed 12945028Gray AT, Schafhalter-Zoppoth I. Ultrasound guidance for ulnar nerve block in the forearm. Reg Anesth Pain Med. 2003 Jul-Aug;28(4):335-9. doi: 10.1016/s1098-7339(03)00196-2.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nanette Schwann, M.D. principal investigator
Allentown Anesthesia Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ultrasound (Sonosite Titan T-shaped ultrasound probe) and Electrical Nerve Stimulation (Stimuplex (B Braun) needle) in people with Trauma to the Arm, Shoulder, Elbow, Forearm, or Hand, run by Allentown Anesthesia Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01010412, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2012.