Shoulder ArthroscopyNCT01877330
Optimal Location of Local Anesthetic Injection for Ultrasound Guided Interscalene Block
A study testing Interscalene block for shoulder arthroscopy in people with Shoulder Arthroscopy and Ultrasound-guided Interscalene Nerve Block, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a prospective randomized clinical trial to determine where is the optimal location for local anesthetic injection for ultrasound guided interscalene nerve blocks. The investigators are investigating if local anesthetic deposited between the nerve roots is more effective than local anesthetic deposited in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Arthroscopy, Ultrasound-guided Interscalene Nerve Block
- What is being tested?
- Interscalene block for shoulder arthroscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Apr 2016
- Phase
- Interventional
- 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
- ASA I-II patients who are 18 years and older and who are scheduled for shoulder arthroscopy are eligible for enrollment provided they do not have any of the following exclusion criteria.
Who cannot join
- chronic pain
- high preoperative opioid requirement
- age < 18 years old
- non-English speaking
- contraindication to regional anesthesia (allergy to local anesthetics, coagulopathy, severe thrombocytopenia, pre-existing neuropathy in operative limb, infection at puncture site)
- need for postoperative nerve function monitoring
Show all 9Show fewer
- patient refusal
- dementia
- pulmonary disease or low baseline oxygen saturation
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Orthopedic Institute
San Francisco, California, 94158
About this study
Official title: Intraplexus vs Extraplexus Injection of Local Anesthetic for Interscalene Block for Patients Undergoing Arthroscopic Shoulder Surgery
This is a prospective randomized clinical trial to determine where is the optimal location for local anesthetic injection for ultrasound guided interscalene nerve blocks. The investigators are investigating if local anesthetic deposited between the nerve roots is more effective than local anesthetic deposited in the interscalene groove.
- Being tested
- Interscalene block for shoulder arthroscopy
- Keywords
- shoulder arthroscopy, ultrasound guided nerve block, interscalene nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene block for shoulder arthroscopyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Injection in interscalene groove | Active comparator | Patients undergoing shoulder arthroscopy will have an interscalene nerve block by injection of ropivacaine in the interscalene groove anterior and posterior to the brachial plexus nerves. Receives: Procedure: Interscalene block for shoulder arthroscopy |
| Injection between nerve roots | Active comparator | Patients undergoing shoulder arthroscopy will have an interscalene nerve block by injection of ropivacaine in the interscalene groove inbetween the C5 and C6 nerve roots. Receives: Procedure: Interscalene block for shoulder arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of motor blockade
Time to loss of shoulder abduction.
Measured: 1 hour from time of injection
Secondary outcomes (8)
Patient Satisfaction Score
Measured: 24 hours
Opioid consumption
Opioid consumption - perioperative and post discharge
Measured: 24 hours
Quality of Nerve block
onset of sensory block
Measured: 24 hours
Incidence of post-operative nausea/vomiting
Measured: 24 hours
Duration of nerve block
Duration of analgesia from nerve block
Measured: 24 hours
Number of needle passes
Measured: 1 hour
Number of paresthesias
number of paresthesia experience during nerve block
Measured: 1 hour
Residual paresthesia
incidence of residual paresthesias
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthroscopyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedram Aleshi, MD, Principal investigator, University of California, San FranciscoMonica W Harbell, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877330
- Sponsor's protocol ID
- ISNB001
- Status last verified
- Mar 2020
- First submitted
- 12 Dec 2012
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraplexus vs Extraplexus Injection of Local Anesthetic for Interscalene Block for Patients Undergoing Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT01877330
- Acronym / sponsor ID
- ISNB001
- Keywords
- shoulder arthroscopy, ultrasound guided nerve block, interscalene nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 Jun 2013 (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.
This is a prospective randomized clinical trial to determine where is the optimal location for local anesthetic injection for ultrasound guided interscalene nerve blocks. The investigators are investigating if local anesthetic deposited between the nerve roots is more effective than local anesthetic deposited in the interscalene groove.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection in interscalene groove | Active comparator | Procedure: Interscalene block for shoulder arthroscopyPatients undergoing shoulder arthroscopy will have an interscalene nerve block by injection of ropivacaine in the interscalene groove anterior and posterior to the brachial plexus nerves. |
| Injection between nerve roots | Active comparator | Procedure: Interscalene block for shoulder arthroscopyPatients undergoing shoulder arthroscopy will have an interscalene nerve block by injection of ropivacaine in the interscalene groove inbetween the C5 and C6 nerve roots. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-II patients who are 18 years and older and who are scheduled for shoulder arthroscopy are eligible for enrollment provided they do not have any of the following exclusion criteria.
Key exclusion criteria (9 listed)
- chronic pain
- high preoperative opioid requirement
- age < 18 years old
- non-English speaking
- contraindication to regional anesthesia (allergy to local anesthetics, coagulopathy, severe thrombocytopenia, pre-existing neuropathy in operative limb, infection at puncture site)
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 block for shoulder arthroscopy | Procedure or surgery | Injection between nerve roots, Injection in interscalene groove |
Primary outcome
Onset of motor blockade
Time frame: 1 hour from time of injection
Time to loss of shoulder abduction.
8 secondary outcomes
Patient Satisfaction Score
Time frame: 24 hours
Opioid consumption
Time frame: 24 hours
Quality of Nerve block
Time frame: 24 hours
Incidence of post-operative nausea/vomiting
Time frame: 24 hours
Duration of nerve block
Time frame: 24 hours
Number of needle passes
Time frame: 1 hour
Number of paresthesias
Time frame: 1 hour
Residual paresthesia
Time frame: 24 hour
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 19 Mar 2020.
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Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
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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.
Pedram Aleshi, MD principal investigator
University of California, San Francisco
Monica W Harbell, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interscalene block for shoulder arthroscopy in people with Shoulder Arthroscopy and Ultrasound-guided Interscalene Nerve Block, run by University of California, San Francisco 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 1 inclusion and 9 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 19 Mar 2020. 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.
What does the primary outcome measure?
Onset of motor blockade (time frame: 1 hour from time of injection). It is what the study was designed to measure, not a finding.
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 19 Mar 2020.