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

NCT ID: NCT03487874

Last Updated: 2019-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-04

Study Completion Date

2019-08-09

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Brachial Plexus Block Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Interscalene block with C8 root block

Intervention Type PROCEDURE

Under ultrasound guidance, the 5th to 8th cervical nerve roots are blocked.

0.75% ropivacaine

Intervention Type DRUG

Placement of 25 to 30 ml of 0.75% ropivacaine around the cervical nerve roots

Conventional interscalene block

The 5th to 7th cervical nerve root block under ultrasound guidance using 25 to 30 ml of 0.75% ropivacaine

Group Type ACTIVE_COMPARATOR

Conventional interscalene block

Intervention Type PROCEDURE

Under ultrasound guidance, the 5th to 7th cervical nerve roots are blocked.

0.75% ropivacaine

Intervention Type DRUG

Placement of 25 to 30 ml of 0.75% ropivacaine around the cervical nerve roots

Interventions

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Conventional interscalene block

Under ultrasound guidance, the 5th to 7th cervical nerve roots are blocked.

Intervention Type PROCEDURE

Interscalene block with C8 root block

Under ultrasound guidance, the 5th to 8th cervical nerve roots are blocked.

Intervention Type PROCEDURE

0.75% ropivacaine

Placement of 25 to 30 ml of 0.75% ropivacaine around the cervical nerve roots

Intervention Type DRUG

Other Intervention Names

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Naropin

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daegu Catholic University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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JongHae Kim

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jong Hae Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Daegu Catholic University Medical Center

Locations

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Daegu Catholic University Medical Center

Daegu, , South Korea

Site Status

Countries

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South Korea

References

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Kim E, Choi CH, Kim JH. Effects of C8 nerve root block during interscalene brachial plexus block on anesthesia of the posterior shoulder in patients undergoing arthroscopic shoulder surgery: study protocol for a prospective randomized parallel-group controlled trial. Trials. 2019 Aug 28;20(1):533. doi: 10.1186/s13063-019-3624-9.

Reference Type DERIVED
PMID: 31455407 (View on PubMed)

Other Identifiers

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CR-18-018

Identifier Type: -

Identifier Source: org_study_id

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