Shoulder ArthroscopyLow Dose ISBNCT01701115
Effect of Local Anesthetic Dose on Interscalene Block
A study testing Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block and Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine) in people with Shoulder Arthroscopy and Interscalene Block, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
The purpose of this study is to determine if a decrease in the standard volume of local anesthetic used to numb your shoulder area before shoulder arthroscopy will provide adequate anesthesia for the procedure and decrease the amount of time until you are ready for discharge from the hospital. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Arthroscopy, Interscalene Block
- What is being tested?
- Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block and Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18 - 80 years old
- Surgical time < 2.5 hours
- ASA I, II or III
- Shoulder arthroscopy
Who cannot join
- Age < 18 or > 80 years old
- Chronic pain patients (on narcotics/opioids > 3 months)
- Open shoulder surgical procedure
- BMI > 40
- Pre-existing neurological condition
- Patient refusal of interscalene block
Show all 9Show fewer
- Severe respiratory disease or hemidiaphragmatic dysfunction
- Allergy to any local anesthetics
- Planned general anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Effect of Local Anesthetic Dose on Interscalene Block for Shoulder Arthroscopy, Patient Satisfaction and Return of Handgrip Strength
The purpose of this study is to determine if a decrease in the standard volume of local anesthetic used to numb your shoulder area before shoulder arthroscopy will provide adequate anesthesia for the procedure and decrease the amount of time until you are ready for discharge from the hospital.
Read the detailed description
Traditionally, an interscalene block is done either with nerve stimulator or ultrasound guided using 40-60mL of local anesthetic. The study plans to investigate the difference in hand grip strength post-operatively in patients who will receive interscalene blocks with 40mL versus a lower dose (20mL) of local anesthetic. We suspect the lower dose will achieve adequate surgical anesthesia while creating less motor block and thus, increase patient satisfaction, present fewer complications or adverse affects and decrease time in the recovery room.
- Conditions
- Shoulder Arthroscopy, Interscalene Block
- Being tested
- Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block, Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block, Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine), Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)
- Keywords
- Interscalene Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose (20 ml) Local Anesthetic Volume for Interscalene BlockProcedure or surgery
Anesthetic volume:
Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL
Control Dose (40 mL) Local Anesthetic Volume for Interscalene BlockProcedure or surgery
Anesthetic volume:
Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL
Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)Drug
Also called Mepivacaine, Bupivacaine
Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)Drug
Also called Mepivacaine, Bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Low Dose (20 mL) Local Anesthetic | Experimental | Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine. Receives: Procedure: Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block; Drug: Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine) |
| Control Dose (40 mL) Local Anesthetic | Active comparator | Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine Receives: Procedure: Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block; Drug: Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handgrip Strength
The primary outcome will be handgrip strength as measured by a dynamometer. A reading will be obtained at baseline (before the interscalene block) and 60 minutes post-operative.
Measured: Difference between between baseline and postoperative.
Secondary outcomes (3)
Patient Readiness to Discharge
Measured: Participants will be followed every 15 minutes post-surgery until discharged from the hospital (up to 180 minutes)
Duration of Analgesia
Time to pain
Measured: Postoperative Day 2
Side Effects
Incidence of nausea
Measured: Postoperative Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Shoulder ArthroscopyStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701115
- Sponsor's protocol ID
- 2012-011
- Acronym
- Low Dose ISB
- Status last verified
- Oct 2017
- First submitted
- 24 Sep 2012
- Last updated
- 4 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Anesthetic Dose on Interscalene Block for Shoulder Arthroscopy, Patient Satisfaction and Return of Handgrip Strength
- ClinicalTrials.gov ID
- NCT01701115
- Acronym / sponsor ID
- Low Dose ISB / 2012-011
- Conditions
- Shoulder Arthroscopy, Interscalene Block
- Keywords
- Interscalene Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Posted 4 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if a decrease in the standard volume of local anesthetic used to numb your shoulder area before shoulder arthroscopy will provide adequate anesthesia for the procedure and decrease the amount of time until you are ready for discharge from the hospital.
Detailed description
Traditionally, an interscalene block is done either with nerve stimulator or ultrasound guided using 40-60mL of local anesthetic. The study plans to investigate the difference in hand grip strength post-operatively in patients who will receive interscalene blocks with 40mL versus a lower dose (20mL) of local anesthetic. We suspect the lower dose will achieve adequate surgical anesthesia while creating less motor block and thus, increase patient satisfaction, present fewer complications or adverse affects and decrease time in the recovery room.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose (20 mL) Local Anesthetic | Experimental | Procedure: Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block, Drug: Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine. |
| Control Dose (40 mL) Local Anesthetic | Active comparator | Procedure: Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block, Drug: Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18 - 80 years old
- Surgical time < 2.5 hours
- ASA I, II or III
- Shoulder arthroscopy
Key exclusion criteria (9 listed)
- Age < 18 or > 80 years old
- Chronic pain patients (on narcotics/opioids > 3 months)
- Open shoulder surgical procedure
- BMI > 40
- Pre-existing neurological condition
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 |
|---|---|---|
| Low Dose (20 ml) Local Anesthetic Volume for Interscalene BlockAnesthetic volume: Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL | Procedure or surgery | Low Dose (20 mL) Local Anesthetic |
| Control Dose (40 mL) Local Anesthetic Volume for Interscalene BlockAnesthetic volume: Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL | Procedure or surgery | Control Dose (40 mL) Local Anesthetic |
| Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)Also: Mepivacaine, Bupivacaine | Drug | Low Dose (20 mL) Local Anesthetic |
| Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)Also: Mepivacaine, Bupivacaine | Drug | Control Dose (40 mL) Local Anesthetic |
Primary outcome
Handgrip Strength
Time frame: Difference between between baseline and postoperative.
The primary outcome will be handgrip strength as measured by a dynamometer. A reading will be obtained at baseline (before the interscalene block) and 60 minutes post-operative.
3 secondary outcomes
Patient Readiness to Discharge
Time frame: Participants will be followed every 15 minutes post-surgery until discharged from the hospital (up to 180 minutes)
Duration of Analgesia
Time frame: Postoperative Day 2
Side Effects
Time frame: Postoperative Day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Analgesia in Arthroscopic Shoulder Surgery
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block and Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine) in people with Shoulder Arthroscopy and Interscalene Block, run by Hospital for Special Surgery, New York 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 4 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 4 Oct 2017. 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?
Yes. Results are posted in the registry (first posted 4 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Handgrip Strength (time frame: Difference between between baseline and postoperative.). 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 4 Oct 2017.