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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block | Procedure | Anesthetic volume: Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Difference between between baseline and postoperative. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Readiness to Discharge | Participants will be followed every 15 minutes post-surgery until discharged from the hospital (up to 180 minutes) | |
| Duration of Analgesia | Time to pain | Postoperative Day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose (20 mL) Local Anesthetic | 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. Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume: Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block | Procedure | Anesthetic volume: Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL |
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| Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine) | Drug |
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| Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine) | Drug |
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| Side Effects | Incidence of nausea | Postoperative Day 2 |
| FG001 | Control Dose (40 mL) Local Anesthetic | 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 Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume: Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose (20 mL) Local Anesthetic | 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. Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume: Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine) |
| BG001 | Control Dose (40 mL) Local Anesthetic | 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 Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume: Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Number | Percentage of participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | kg | Difference between between baseline and postoperative. |
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| Secondary | Patient Readiness to Discharge | Posted | Mean | Standard Deviation | minutes | Participants will be followed every 15 minutes post-surgery until discharged from the hospital (up to 180 minutes) |
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| Secondary | Duration of Analgesia | Time to pain | Posted | Median | 95% Confidence Interval | minutes | Postoperative Day 2 |
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| Secondary | Side Effects | Incidence of nausea | Posted | Count of Participants | Participants | Postoperative Day 2 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose (20 mL) Local Anesthetic | 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. Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume: Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine) | 0 | 75 | 0 | 75 | ||
| EG001 | Control Dose (40 mL) Local Anesthetic | 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 Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume: Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine) | 0 | 77 | 0 | 77 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Maalouf | HSS | (212) 606-1000 | MaaloufD@HSS.EDU |
| ID | Term |
|---|---|
| D000779 | Anesthetics, Local |
| D008619 | Mepivacaine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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