Brachial Plexus BlockNCT03487874
Efficacy of the C8 Nerve Root Block During Interscalene Block for Anesthesia of the Posterior Aspect of the Shoulder
A study testing Conventional interscalene block, Interscalene block with C8 root block and 0.75% ropivacaine in people with Brachial Plexus Block and Shoulder Pain, run by Daegu Catholic University Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Brachial Plexus Block, Shoulder Pain
- What is being tested?
- Conventional interscalene block, Interscalene block with C8 root block and 0.75% ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Apr 2018to 9 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status 1 and 2
- Arthroscopic shoulder surgery under interscalene brachial plexus block
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Brachial Plexus Block, Shoulder Pain
- Being tested
- Conventional interscalene block, Interscalene block with C8 root block, 0.75% ropivacaine
- Keywords
- 8th cervical nerve root block
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional interscalene blockProcedure or surgery
Under ultrasound guidance, the 5th to 7th cervical nerve roots are blocked.
Interscalene block with C8 root blockProcedure or surgery
Under ultrasound guidance, the 5th to 8th cervical nerve roots are blocked.
0.75% ropivacaineDrug
Also called Naropin
Placement of 25 to 30 ml of 0.75% ropivacaine around the cervical nerve roots
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Interscalene block with C8 root block; Drug: 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 Receives: Procedure: Conventional interscalene block; Drug: 0.75% ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity upon the introduction of a posterior portal
0, 1, and 2 represent no pain, mild pain, and severe pain, respectively.
Measured: 50 minutes after interscalene block
Secondary outcomes (18)
Sensory blockade
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
Measured: 30 minutes after interscalene block
Motor blockade
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)
Measured: 30 minutes after interscalene block
Ipsilateral hemidiaphragmatic blockade
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
Measured: Before interscalene block and 30 minutes after interscalene block
Horner's syndrome
The extent of a reduction in the ipsilateral pupil size measured by a pupillometer Presence or absence of ptosis
Measured: Before interscalene block and 30 minutes after interscalene block
Pulmonary function test
Forced expiratory volume at one second (FEV1) and FEV1/forced vital capacity before and 30 minutes after the end of local anesthetic injection
Measured: Before interscalene block and 30 minutes after interscalene block
Complications related with interscalene block
Presence or absence of vascular puncture, local anesthetic systemic toxicity, pneumothorax, and paresthesia
Measured: 24 hours
Numerical pain rating score at admission to postanesthetic care unit
Numerical pain rating score ranging from 0 to 10 (0 = no pain, 10 = worst pain imaginable) at admission to postanesthetic care unit
Measured: 5 minutes
Numerical pain rating score at discharge from postanesthetic care unit
Numerical pain rating score ranging from 0 to 10 (0 = no pain, 10 = worst pain imaginable) at discharge from postanesthetic care unit
Measured: 30 minutes
Numerical pain rating score between 6 and 12 hours after surgery
Numerical pain rating score ranging from 0 to 10 (0 = no pain, 10 = worst pain imaginable) between 6 and 12 hours after surgery
Measured: 6 and 12 hours
Numerical pain rating score 24 hours after surgery
Numerical pain rating score ranging from 0 to 10 (0 = no pain, 10 = worst pain imaginable) 24 hours after surgery
Measured: 24 hours
Worst numerical pain rating score
Worst numerical pain rating score ranging from 0 to 10 (0 = no pain, 10 = worst pain imaginable) during 24 hours after surgery
Measured: 24 hours
Postoperative hour when pain starts to be felt
Time at regression of anesthesia which starts to cause postoperative pain during 24 hours after surgery
Measured: 24 hours
Patient's satisfaction about surgical anesthesia and postoperative analgesia
Likert scale consisting of "very dissatisfied", "dissatisfied", "unsure", "satisfied", and "very satisfied"
Measured: 24 hours
Dose of postoperative analgesic use
Cumulative dose of analgesic required for postoperative analgesia during 24 hours after surgery
Measured: 24 hours
Frequency of postoperative analgesic use
Frequency of analgesic use during 24 hours after surgery
Measured: 24 hours
Dose of intraoperative analgesic use
Cumulative dose of analgesic to supplement incomplete surgical anesthesia
Measured: 2 hours
Frequency of intraoperative analgesic use
Frequency of analgesic use to supplement incomplete surgical anesthesia
Measured: 2 hours
Conversion into general anesthesia
Number of patients whose regional anesthesia is converted into general anesthesia due to incomplete surgical anesthesia provided by the regional anesthesia
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start4 Apr 2018
- Primary completion8 Aug 2019
- Study completion9 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brachial Plexus BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daegu Catholic University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JongHae Kim, Daegu Catholic University Medical Center
- Investigators
- Jong Hae Kim, MD, Principal investigator, Daegu Catholic University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487874
- Sponsor's protocol ID
- CR-18-018
- Status last verified
- Aug 2019
- First submitted
- 22 Mar 2018
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31455407
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the 8th Cervical Nerve Root Block During Interscalene Brachial Plexus Block for Arthroscopic Shoulder Surgery: Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03487874
- Acronym / sponsor ID
- CR-18-018
- Conditions
- Brachial Plexus Block, Shoulder Pain
- Keywords
- 8th cervical nerve root block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Daegu Catholic University Medical CenterUniversity, hospital or other
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 9 Aug 2019 (actual)
- First posted
- 4 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interscalene block with C8 root block | Experimental | Procedure: Interscalene block with C8 root block, Drug: 0.75% ropivacaineThe 5th to 8th cervical nerve root block under ultrasound guidance using 25 to 30 ml of 0.75% ropivacaine |
| Conventional interscalene block | Active comparator | Procedure: Conventional interscalene block, Drug: 0.75% ropivacaineThe 5th to 7th cervical nerve root block under ultrasound guidance using 25 to 30 ml of 0.75% ropivacaine |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status 1 and 2
- Arthroscopic shoulder surgery under interscalene brachial plexus block
Key exclusion criteria (8 listed)
- Patient refusal
- Contralateral hemidiaphragmatic paralysis or paresis
- Contralateral vocal cord palsy
- Severe pulmonary restrictive disease
- Coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional interscalene blockUnder ultrasound guidance, the 5th to 7th cervical nerve roots are blocked. | Procedure or surgery | Conventional interscalene block |
| Interscalene block with C8 root blockUnder ultrasound guidance, the 5th to 8th cervical nerve roots are blocked. | Procedure or surgery | Interscalene block with C8 root block |
| 0.75% ropivacaineAlso: NaropinPlacement of 25 to 30 ml of 0.75% ropivacaine around the cervical nerve roots | Drug | Conventional interscalene block, Interscalene block with C8 root block |
Primary outcome
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.
18 secondary outcomes
Sensory blockade
Time frame: 30 minutes after interscalene block
Motor blockade
Time frame: 30 minutes after interscalene block
Ipsilateral hemidiaphragmatic blockade
Time frame: Before interscalene block and 30 minutes after interscalene block
Horner's syndrome
Time frame: Before interscalene block and 30 minutes after interscalene block
Pulmonary function test
Time frame: Before interscalene block and 30 minutes after interscalene block
Complications related with interscalene block
Time frame: 24 hours
Numerical pain rating score at admission to postanesthetic care unit
Time frame: 5 minutes
Numerical pain rating score at discharge from postanesthetic care unit
Time frame: 30 minutes
Numerical pain rating score between 6 and 12 hours after surgery
Time frame: 6 and 12 hours
Numerical pain rating score 24 hours after surgery
Time frame: 24 hours
Worst numerical pain rating score
Time frame: 24 hours
Postoperative hour when pain starts to be felt
Time frame: 24 hours
Patient's satisfaction about surgical anesthesia and postoperative analgesia
Time frame: 24 hours
Dose of postoperative analgesic use
Time frame: 24 hours
Frequency of postoperative analgesic use
Time frame: 24 hours
Dose of intraoperative analgesic use
Time frame: 2 hours
Frequency of intraoperative analgesic use
Time frame: 2 hours
Conversion into general anesthesia
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Derived from this study: PubMed 31455407Kim 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.
- Individual participant dataSharing planned: No
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Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
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Not yet recruiting
Perfusion Index in Monitoring Recovery From Brachial Plexus Block After Forearm Surgery
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RecruitingObservational study
Pulse Wave Transit Time After Infraclavicular Block
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RecruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong Hae Kim, MD principal investigator
Daegu Catholic University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional interscalene block, Interscalene block with C8 root block and 0.75% ropivacaine in people with Brachial Plexus Block and Shoulder Pain, run by Daegu Catholic University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity upon the introduction of a posterior portal (time frame: 50 minutes after interscalene block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03487874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.