Shoulder SurgeryNCT01229683
Effects of Interscalene Brachial Plexus Nerve Blocks on the Hand and Forearm
An observational study of Shoulder Surgery and Interscalene Nerve Block, run by University of California, San Diego at 1 site in United States.
Trial summary
Research study to determine the proportion of cases in which an interscalene brachial plexus nerve block produces hand and forearm anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Surgery, Interscalene Nerve Block
- What is being tested?
- Interscalene Nerve Block
- Type of treatment
- Surgery or procedure
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Mar 2012
- Phase
- Observational
- 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
Study population: Study population will consist only of patients undergoing orthopedic shoulder surgery.
Who may be able to join
- 18 years of age or older
- unilateral orthopedic shoulder surgery
- already desiring an interscalene brachial plexus nerve block for postoperative analgesia with the anesthetic plan including a preoperative interscalene nerve block with mepivacaine
Who cannot join
- any known contraindication to study medications or testing hand grip strength pre/post-op
- insulin-dependent diabetes mellitus
- neuropathy of any etiology in the affected extremity
- any anticipated incision site apart from the shoulder
- Obesity
- Pregnancy
- Incarceration
- inability to communicate with the investigators and hospital staff
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Medical Centers (Hillcrest and Thornton)
San Diego, California, 92103
About this study
Research study to determine the proportion of cases in which an interscalene brachial plexus nerve block produces hand and forearm anesthesia.
Read the detailed description
This is a research study to prospectively determine the proportion of cases in which an interscalene brachial plexus nerve block produces hand and forearm anesthesia. The investigators will investigate this issue in patients having shoulder and not hand/forearm surgery. We will test hand grip strength and sensation to determine if the hand and forearm are responding to the anesthesia.
- Conditions
- Shoulder Surgery, Interscalene Nerve Block
- Being tested
- Interscalene Nerve Block
- Keywords
- UCSD, Perineural Nerve Block, Shoulder Surgery, Pain, Grip Strength, Sensation, Interscalene Nerve Block
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene Nerve BlockProcedure or surgery
Patients undergoing shoulder surgery will be given an Interscalene Nerve Block. The patients' strength and sensation in their hand and forearm will be tested to determine if the nerve block is affectively delivering anesthetic to the nerves that serve these areas.
| Study group | Role | What they receive |
|---|---|---|
| Shoulder Surgery | Patients will be given an interscalene nerve block and then strength and sensation of the hand and forearm will be tested to determine if the block is helping to anesthetize these areas. Receives: Procedure: Interscalene Nerve Block |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder SurgeryStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian M. Ilfeld, MD, MS, University of California, San Diego
- Investigators
- Brian M Ilfeld, M.D., M.S., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229683
- Sponsor's protocol ID
- Madison Block
- Status last verified
- Mar 2012
- First submitted
- 27 Oct 2010
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Interscalene Brachial Plexus Nerve Blocks on the Hand and Forearm
- ClinicalTrials.gov ID
- NCT01229683
- Acronym / sponsor ID
- Madison Block
- Conditions
- Shoulder Surgery, Interscalene Nerve Block
- Keywords
- UCSD, Perineural Nerve Block, Shoulder Surgery, Pain, Grip Strength, Sensation, Interscalene Nerve Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 28 Oct 2010 (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.
Research study to determine the proportion of cases in which an interscalene brachial plexus nerve block produces hand and forearm anesthesia.
Detailed description
This is a research study to prospectively determine the proportion of cases in which an interscalene brachial plexus nerve block produces hand and forearm anesthesia. The investigators will investigate this issue in patients having shoulder and not hand/forearm surgery. We will test hand grip strength and sensation to determine if the hand and forearm are responding to the anesthesia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shoulder Surgery | – | Procedure: Interscalene Nerve BlockPatients will be given an interscalene nerve block and then strength and sensation of the hand and forearm will be tested to determine if the block is helping to anesthetize these areas. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will consist only of patients undergoing orthopedic shoulder surgery.
Key inclusion criteria (3 listed)
- 18 years of age or older
- unilateral orthopedic shoulder surgery
- already desiring an interscalene brachial plexus nerve block for postoperative analgesia with the anesthetic plan including a preoperative interscalene nerve block with mepivacaine
Key exclusion criteria (8 listed)
- any known contraindication to study medications or testing hand grip strength pre/post-op
- insulin-dependent diabetes mellitus
- neuropathy of any etiology in the affected extremity
- any anticipated incision site apart from the shoulder
- Obesity
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 |
|---|---|---|
| Interscalene Nerve BlockPatients undergoing shoulder surgery will be given an Interscalene Nerve Block. The patients' strength and sensation in their hand and forearm will be tested to determine if the nerve block is affectively delivering anesthetic to the nerves that serve these areas. | Procedure or surgery | Shoulder Surgery |
Primary outcome
Not reported in the source record.
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 8 Mar 2012.
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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.
Brian M Ilfeld, M.D., M.S. principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Surgery and Interscalene Nerve Block, run by University of California, San Diego 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 8 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 8 Mar 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.
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.
Where can I read the original study information?
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 8 Mar 2012.