Efficacy of the C8 Nerve Root Block During Interscalene Block for Anesthesia of the Posterior Aspect of the Shoulder

August 8, 2019 updated by: JongHae Kim, Daegu Catholic University Medical Center

Efficacy of the 8th Cervical Nerve Root Block During Interscalene Brachial Plexus Block for Arthroscopic Shoulder Surgery: Prospective Randomized Controlled Study

This study evaluates the effects of selective 8th cervical nerve root block during interscalene brachial plexus block on the relief of pain intensity upon the introduction of a posterior portal during arthroscopic shoulder surgery. The 5th to 7th cervical nerve roots will be blocked in half of participants, while the 5th to 8th cervical nerve roots will be blocked in the other half.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

By blocking only the 5th to 7th cervical nerve blocks, conventional interscalene brachial plexus block spares the 8th cervical and 1st thoracic dermatomes which innervate the posterior aspect of the shoulder. To visualize the shoulder joint space during shoulder arthroscopic surgery, the introduction of a posterior portal is essential. However, conventional interscalene brachial plexus block cannot effectively relieve the pain caused by its insertion due to sparing of the 8th cervical and 1st thoracic dermatomes. The addition of the 8th cervical nerve root block to conventional interscalene brachial plexus block decreases pain intensity upon the introduction of a posterior portal.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Korea, Republic of
      • Daegu, Korea, Republic of, 42472
        • Daegu Catholic University Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologists physical status 1 and 2
  • Arthroscopic shoulder surgery under interscalene brachial plexus block

Exclusion Criteria:

  • Patient refusal
  • Contralateral hemidiaphragmatic paralysis or paresis
  • Contralateral vocal cord palsy
  • Severe pulmonary restrictive disease
  • Coagulopathy
  • Allergy to local anesthetics or history of allergic shock
  • Difficulty communicating with medical personnel
  • Peripheral neuropathy or neurologic sequelae on the operative limb

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: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Interscalene block with C8 root block
The 5th to 8th cervical nerve root block under ultrasound guidance using 25 to 30 ml of 0.75% ropivacaine
Procedure: Interscalene block with C8 root block
Under ultrasound guidance, the 5th to 8th cervical nerve roots are blocked.
Drug: 0.75% ropivacaine
Placement of 25 to 30 ml of 0.75% ropivacaine around the cervical nerve roots
Other Names:
  • Naropin
Active Comparator: Conventional interscalene block
The 5th to 7th cervical nerve root block under ultrasound guidance using 25 to 30 ml of 0.75% ropivacaine
Drug: 0.75% ropivacaine
Placement of 25 to 30 ml of 0.75% ropivacaine around the cervical nerve roots
Other Names:
  • Naropin
Procedure: Conventional interscalene block
Under ultrasound guidance, the 5th to 7th cervical nerve roots are blocked.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain intensity upon the introduction of a posterior portal
Time Frame: 50 minutes after interscalene block
0, 1, and 2 represent no pain, mild pain, and severe pain, respectively.
50 minutes after interscalene block

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sensory blockade
Time Frame: 30 minutes after interscalene block
C5 to T1 dermatomal blockade graded from 0 to 2 (0 = no cold sensation, 1 = reduced cold sensation, and 2 = normal cold sensation) by applying ice to the shoulder
30 minutes after interscalene block
Motor blockade
Time Frame: 30 minutes after interscalene block
Motor blockade of the radial, ulnar, median, musculocutaneous, and axillary nerves graded from 0 to 2 (0 = complete block, 1 = partial block, and 2 = no block)
30 minutes after interscalene block
Ipsilateral hemidiaphragmatic blockade
Time Frame: Before interscalene block and 30 minutes after interscalene block
Extent of a reduction in the amplitude of excursion of the diaphragm on the vertical axis of the M-mode wave under M-mode ultrasound evaluation
Before interscalene block and 30 minutes after interscalene block
Horner's syndrome
Time Frame: Before interscalene block and 30 minutes after interscalene block
The extent of a reduction in the ipsilateral pupil size measured by a pupillometer Presence or absence of ptosis
Before interscalene block and 30 minutes after interscalene block
Pulmonary function test
Time Frame: Before interscalene block and 30 minutes after interscalene block
Forced expiratory volume at one second (FEV1) and FEV1/forced vital capacity before and 30 minutes after the end of local anesthetic injection
Before interscalene block and 30 minutes after interscalene block
Complications related with interscalene block
Time Frame: 24 hours
Presence or absence of vascular puncture, local anesthetic systemic toxicity, pneumothorax, and paresthesia
24 hours
Numerical pain rating score at admission to postanesthetic care unit
Time Frame: 5 minutes
Numerical pain rating score ranging from 0 to 10 (0 = no pain, 10 = worst pain imaginable) at admission to postanesthetic care unit
5 minutes
Numerical pain rating score at discharge from postanesthetic care unit
Time Frame: 30 minutes
Numerical pain rating score ranging from 0 to 10 (0 = no pain, 10 = worst pain imaginable) at discharge from postanesthetic care unit
30 minutes
Numerical pain rating score between 6 and 12 hours after surgery
Time Frame: 6 and 12 hours
Numerical pain rating score ranging from 0 to 10 (0 = no pain, 10 = worst pain imaginable) between 6 and 12 hours after surgery
6 and 12 hours
Numerical pain rating score 24 hours after surgery
Time Frame: 24 hours
Numerical pain rating score ranging from 0 to 10 (0 = no pain, 10 = worst pain imaginable) 24 hours after surgery
24 hours
Worst numerical pain rating score
Time Frame: 24 hours
Worst numerical pain rating score ranging from 0 to 10 (0 = no pain, 10 = worst pain imaginable) during 24 hours after surgery
24 hours
Postoperative hour when pain starts to be felt
Time Frame: 24 hours
Time at regression of anesthesia which starts to cause postoperative pain during 24 hours after surgery
24 hours
Patient's satisfaction about surgical anesthesia and postoperative analgesia
Time Frame: 24 hours
Likert scale consisting of "very dissatisfied", "dissatisfied", "unsure", "satisfied", and "very satisfied"
24 hours
Dose of postoperative analgesic use
Time Frame: 24 hours
Cumulative dose of analgesic required for postoperative analgesia during 24 hours after surgery
24 hours
Frequency of postoperative analgesic use
Time Frame: 24 hours
Frequency of analgesic use during 24 hours after surgery
24 hours
Dose of intraoperative analgesic use
Time Frame: 2 hours
Cumulative dose of analgesic to supplement incomplete surgical anesthesia
2 hours
Frequency of intraoperative analgesic use
Time Frame: 2 hours
Frequency of analgesic use to supplement incomplete surgical anesthesia
2 hours
Conversion into general anesthesia
Time Frame: 1 hour
Number of patients whose regional anesthesia is converted into general anesthesia due to incomplete surgical anesthesia provided by the regional anesthesia
1 hour

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daegu Catholic University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jong Hae Kim, MD, Daegu Catholic University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 8, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 9, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR-18-018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings