Efficacy of the C8 Nerve Root Block During Interscalene Block for Anesthesia of the Posterior Aspect of the Shoulder
Primary Purpose
Brachial Plexus Block, Shoulder Pain
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Conventional interscalene block
Interscalene block with C8 root block
0.75% ropivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Brachial Plexus Block focused on measuring 8th cervical nerve root block
Eligibility Criteria
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
Sites / Locations
- Daegu Catholic University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Interscalene block with C8 root block
Conventional interscalene block
Arm Description
The 5th to 8th cervical nerve root block under ultrasound guidance using 25 to 30 ml of 0.75% ropivacaine
The 5th to 7th cervical nerve root block under ultrasound guidance using 25 to 30 ml of 0.75% ropivacaine
Outcomes
Primary Outcome Measures
Pain intensity upon the introduction of a posterior portal
0, 1, and 2 represent no pain, mild pain, and severe pain, respectively.
Secondary Outcome Measures
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
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)
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
Horner's syndrome
The extent of a reduction in the ipsilateral pupil size measured by a pupillometer Presence or absence of ptosis
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
Complications related with interscalene block
Presence or absence of vascular puncture, local anesthetic systemic toxicity, pneumothorax, and paresthesia
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
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
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
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
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
Postoperative hour when pain starts to be felt
Time at regression of anesthesia which starts to cause postoperative pain during 24 hours after surgery
Patient's satisfaction about surgical anesthesia and postoperative analgesia
Likert scale consisting of "very dissatisfied", "dissatisfied", "unsure", "satisfied", and "very satisfied"
Dose of postoperative analgesic use
Cumulative dose of analgesic required for postoperative analgesia during 24 hours after surgery
Frequency of postoperative analgesic use
Frequency of analgesic use during 24 hours after surgery
Dose of intraoperative analgesic use
Cumulative dose of analgesic to supplement incomplete surgical anesthesia
Frequency of intraoperative analgesic use
Frequency of analgesic use to supplement incomplete surgical anesthesia
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
Full Information
NCT ID
NCT03487874
First Posted
March 22, 2018
Last Updated
August 8, 2019
Sponsor
Daegu Catholic University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03487874
Brief Title
Efficacy of the C8 Nerve Root Block During Interscalene Block for Anesthesia of the Posterior Aspect of the Shoulder
Official Title
Efficacy of the 8th Cervical Nerve Root Block During Interscalene Brachial Plexus Block for Arthroscopic Shoulder Surgery: Prospective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 4, 2018 (Actual)
Primary Completion Date
August 8, 2019 (Actual)
Study Completion Date
August 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daegu Catholic University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brachial Plexus Block, Shoulder Pain
Keywords
8th cervical nerve root block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interscalene block with C8 root block
Arm Type
Experimental
Arm Description
The 5th to 8th cervical nerve root block under ultrasound guidance using 25 to 30 ml of 0.75% ropivacaine
Arm Title
Conventional interscalene block
Arm Type
Active Comparator
Arm Description
The 5th to 7th cervical nerve root block under ultrasound guidance using 25 to 30 ml of 0.75% ropivacaine
Intervention Type
Procedure
Intervention Name(s)
Conventional interscalene block
Intervention Description
Under ultrasound guidance, the 5th to 7th cervical nerve roots are blocked.
Intervention Type
Procedure
Intervention Name(s)
Interscalene block with C8 root block
Intervention Description
Under ultrasound guidance, the 5th to 8th cervical nerve roots are blocked.
Intervention Type
Drug
Intervention Name(s)
0.75% ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
Placement of 25 to 30 ml of 0.75% ropivacaine around the cervical nerve roots
Primary Outcome Measure Information:
Title
Pain intensity upon the introduction of a posterior portal
Description
0, 1, and 2 represent no pain, mild pain, and severe pain, respectively.
Time Frame
50 minutes after interscalene block
Secondary Outcome Measure Information:
Title
Sensory blockade
Description
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
Time Frame
30 minutes after interscalene block
Title
Motor blockade
Description
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)
Time Frame
30 minutes after interscalene block
Title
Ipsilateral hemidiaphragmatic blockade
Description
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
Time Frame
Before interscalene block and 30 minutes after interscalene block
Title
Horner's syndrome
Description
The extent of a reduction in the ipsilateral pupil size measured by a pupillometer Presence or absence of ptosis
Time Frame
Before interscalene block and 30 minutes after interscalene block
Title
Pulmonary function test
Description
Forced expiratory volume at one second (FEV1) and FEV1/forced vital capacity before and 30 minutes after the end of local anesthetic injection
Time Frame
Before interscalene block and 30 minutes after interscalene block
Title
Complications related with interscalene block
Description
Presence or absence of vascular puncture, local anesthetic systemic toxicity, pneumothorax, and paresthesia
Time Frame
24 hours
Title
Numerical pain rating score at admission to postanesthetic care unit
Description
Numerical pain rating score ranging from 0 to 10 (0 = no pain, 10 = worst pain imaginable) at admission to postanesthetic care unit
Time Frame
5 minutes
Title
Numerical pain rating score at discharge from postanesthetic care unit
Description
Numerical pain rating score ranging from 0 to 10 (0 = no pain, 10 = worst pain imaginable) at discharge from postanesthetic care unit
Time Frame
30 minutes
Title
Numerical pain rating score between 6 and 12 hours after surgery
Description
Numerical pain rating score ranging from 0 to 10 (0 = no pain, 10 = worst pain imaginable) between 6 and 12 hours after surgery
Time Frame
6 and 12 hours
Title
Numerical pain rating score 24 hours after surgery
Description
Numerical pain rating score ranging from 0 to 10 (0 = no pain, 10 = worst pain imaginable) 24 hours after surgery
Time Frame
24 hours
Title
Worst numerical pain rating score
Description
Worst numerical pain rating score ranging from 0 to 10 (0 = no pain, 10 = worst pain imaginable) during 24 hours after surgery
Time Frame
24 hours
Title
Postoperative hour when pain starts to be felt
Description
Time at regression of anesthesia which starts to cause postoperative pain during 24 hours after surgery
Time Frame
24 hours
Title
Patient's satisfaction about surgical anesthesia and postoperative analgesia
Description
Likert scale consisting of "very dissatisfied", "dissatisfied", "unsure", "satisfied", and "very satisfied"
Time Frame
24 hours
Title
Dose of postoperative analgesic use
Description
Cumulative dose of analgesic required for postoperative analgesia during 24 hours after surgery
Time Frame
24 hours
Title
Frequency of postoperative analgesic use
Description
Frequency of analgesic use during 24 hours after surgery
Time Frame
24 hours
Title
Dose of intraoperative analgesic use
Description
Cumulative dose of analgesic to supplement incomplete surgical anesthesia
Time Frame
2 hours
Title
Frequency of intraoperative analgesic use
Description
Frequency of analgesic use to supplement incomplete surgical anesthesia
Time Frame
2 hours
Title
Conversion into general anesthesia
Description
Number of patients whose regional anesthesia is converted into general anesthesia due to incomplete surgical anesthesia provided by the regional anesthesia
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Hae Kim, MD
Organizational Affiliation
Daegu Catholic University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daegu Catholic University Medical Center
City
Daegu
ZIP/Postal Code
42472
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31455407
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy of the C8 Nerve Root Block During Interscalene Block for Anesthesia of the Posterior Aspect of the Shoulder
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