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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01701115
First Posted: October 4, 2012
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
  Purpose
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 Intervention
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)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • 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:
  • 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 ]
    Time to pain

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


Enrollment: 154
Study Start Date: August 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
Information from the National Library of Medicine

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
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

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01701115     History of Changes
Other Study ID Numbers: 2012-011
First Submitted: September 24, 2012
First Posted: October 4, 2012
Results First Submitted: April 3, 2017
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:
Bupivacaine
Anesthetics, Local
Mepivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents