NCT03487874

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 4, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

April 4, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2019

Completed
Last Updated

August 12, 2019

Status Verified

August 1, 2019

Enrollment Period

1.3 years

First QC Date

March 22, 2018

Last Update Submit

August 8, 2019

Conditions

Brachial Plexus BlockShoulder Pain

Keywords

8th cervical nerve root block

Outcome Measures

Primary Outcomes (1)

  • Pain intensity upon the introduction of a posterior portal

    0, 1, and 2 represent no pain, mild pain, and severe pain, respectively.

    50 minutes after interscalene block

Secondary Outcomes (18)

  • Sensory blockade

    30 minutes after interscalene block

  • Motor blockade

    30 minutes after interscalene block

  • Ipsilateral hemidiaphragmatic blockade

    Before interscalene block and 30 minutes after interscalene block

  • Horner's syndrome

    Before interscalene block and 30 minutes after interscalene block

  • Pulmonary function test

    Before interscalene block and 30 minutes after interscalene block

  • +13 more secondary outcomes

Study Arms (2)

Interscalene block with C8 root block

EXPERIMENTAL

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 blockDrug: 0.75% ropivacaine

Conventional interscalene block

ACTIVE COMPARATOR

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

Procedure: Conventional interscalene blockDrug: 0.75% ropivacaine

Interventions

Conventional interscalene blockPROCEDURE

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

Conventional interscalene block
Interscalene block with C8 root blockPROCEDURE

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

Interscalene block with C8 root block
0.75% ropivacaineDRUG

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

Also known as: Naropin
Conventional interscalene blockInterscalene block with C8 root block

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 31455407DERIVED

MeSH Terms

Conditions

Shoulder Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jong Hae Kim, MD

    Daegu Catholic University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 22, 2018

First Posted

April 4, 2018

Study Start

April 4, 2018

Primary Completion

August 8, 2019

Study Completion

August 9, 2019

Last Updated

August 12, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)