Optimal Location of Local Anesthetic Injection for Ultrasound Guided Interscalene Block

March 17, 2020 updated by: University of California, San Francisco

Intraplexus vs Extraplexus Injection of Local Anesthetic for Interscalene Block for Patients Undergoing Arthroscopic Shoulder Surgery

This is a prospective randomized clinical trial to determine where is the optimal location for local anesthetic injection for ultrasound guided interscalene nerve blocks. The investigators are investigating if local anesthetic deposited between the nerve roots is more effective than local anesthetic deposited in the interscalene groove.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

208

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
    • California
      • San Francisco, California, United States, 94158
        • UCSF Orthopedic Institute

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

ASA I-II patients who are 18 years and older and who are scheduled for shoulder arthroscopy are eligible for enrollment provided they do not have any of the following exclusion criteria.

Exclusion Criteria:

  • chronic pain
  • high preoperative opioid requirement
  • age < 18 years old
  • non-English speaking
  • contraindication to regional anesthesia (allergy to local anesthetics, coagulopathy, severe thrombocytopenia, pre-existing neuropathy in operative limb, infection at puncture site)
  • need for postoperative nerve function monitoring
  • patient refusal
  • dementia
  • pulmonary disease or low baseline oxygen saturation

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Injection in interscalene groove
Patients undergoing shoulder arthroscopy will have an interscalene nerve block by injection of ropivacaine in the interscalene groove anterior and posterior to the brachial plexus nerves.
Procedure: Interscalene block for shoulder arthroscopy
Active Comparator: Injection between nerve roots
Patients undergoing shoulder arthroscopy will have an interscalene nerve block by injection of ropivacaine in the interscalene groove inbetween the C5 and C6 nerve roots.
Procedure: Interscalene block for shoulder arthroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset of motor blockade
Time Frame: 1 hour from time of injection
Time to loss of shoulder abduction.
1 hour from time of injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction Score
Time Frame: 24 hours
24 hours
Opioid consumption
Time Frame: 24 hours
Opioid consumption - perioperative and post discharge
24 hours
Quality of Nerve block
Time Frame: 24 hours
onset of sensory block
24 hours
Incidence of post-operative nausea/vomiting
Time Frame: 24 hours
24 hours
Duration of nerve block
Time Frame: 24 hours
Duration of analgesia from nerve block
24 hours
Number of needle passes
Time Frame: 1 hour
1 hour
Number of paresthesias
Time Frame: 1 hour
number of paresthesia experience during nerve block
1 hour
Residual paresthesia
Time Frame: 24 hour
incidence of residual paresthesias
24 hour

Collaborators and Investigators

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

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Pedram Aleshi, MD, University of California, San Francisco
  • Principal Investigator: Monica W Harbell, MD, University of California, San Francisco

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

January 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

December 12, 2012

First Submitted That Met QC Criteria

June 12, 2013

First Posted (Estimate)

June 13, 2013

Study Record Updates

Last Update Posted (Actual)

March 19, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ISNB001

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.

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