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

October 2, 2017 updated by: Hospital for Special Surgery, New York

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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:
  • Bupivacaine
  • Mepivacaine
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:
  • Bupivacaine
  • Mepivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Difference between between baseline and postoperative.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Readiness to Discharge
Time Frame: Participants will be followed every 15 minutes post-surgery until discharged from the hospital (up to 180 minutes)
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
Postoperative Day 2
Side Effects
Time Frame: Postoperative Day 2
Incidence of nausea
Postoperative Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

August 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

September 24, 2012

First Submitted That Met QC Criteria

October 3, 2012

First Posted (ESTIMATE)

October 4, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 4, 2017

Last Update Submitted That Met QC Criteria

October 2, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Interscalene Block

Clinical Trials on Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe