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Effect of Local Anesthetic Dose on Interscalene Block (Low Dose ISB)

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ClinicalTrials.gov Identifier: NCT01701115
Recruitment Status : Completed
First Posted : October 4, 2012
Results First Posted : October 4, 2017
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Shoulder Arthroscopy Interscalene Block Procedure: Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block Procedure: Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block Drug: Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine) Drug: Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Local Anesthetic Dose on Interscalene Block for Shoulder Arthroscopy, Patient Satisfaction and Return of Handgrip Strength
Study Start Date : August 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Procedure: 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


Drug: Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)
Other Names:
  • Mepivacaine
  • Bupivacaine
Active Comparator: 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
 Procedure: 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


Drug: Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)
Other Names:
  • Mepivacaine
  • Bupivacaine


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Patient Readiness to Discharge [ Time Frame: Participants will be followed every 15 minutes post-surgery until discharged from the hospital (up to 180 minutes) ]
  2. Duration of Analgesia [ Time Frame: Postoperative Day 2 ]
    Time to pain

  3. Side Effects [ Time Frame: Postoperative Day 2 ]
    Incidence of nausea


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: 18 - 80 years old
  • Surgical time < 2.5 hours
  • ASA I, II or III
  • Shoulder arthroscopy

Exclusion Criteria:

  • 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
  • Severe respiratory disease or hemidiaphragmatic dysfunction
  • Allergy to any local anesthetics
  • Planned general anesthesia
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701115


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
More Information
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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01701115    
Other Study ID Numbers: 2012-011
First Posted: October 4, 2012    Key Record Dates
Results First Posted: October 4, 2017
Last Update Posted: October 4, 2017
Last Verified: October 2017
Keywords provided by Hospital for Special Surgery, New York:
Interscalene Block
Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Mepivacaine
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents