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

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: Completed
• Conditions: Shoulder Pain; Brachial Plexus Block
• Intervention / Treatment: Procedure: Interscalene block with C8 root block; Drug: 0.75% ropivacaine; Procedure: Conventional interscalene block

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: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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	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	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	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	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	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	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	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	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	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	24 hours
Patient's satisfaction about surgical anesthesia and postoperative analgesia	Likert scale consisting of "very dissatisfied", "dissatisfied", "unsure", "satisfied", and "very satisfied"	24 hours
Dose of postoperative analgesic use	Cumulative dose of analgesic required for postoperative analgesia during 24 hours after surgery	24 hours
Frequency of postoperative analgesic use	Frequency of analgesic use during 24 hours after surgery	24 hours
Dose of intraoperative analgesic use	Cumulative dose of analgesic to supplement incomplete surgical anesthesia	2 hours
Frequency of intraoperative analgesic use	Frequency of analgesic use to supplement incomplete surgical anesthesia	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	1 hour

Collaborators and Investigators

• Sponsor: Daegu Catholic University Medical Center
• Investigators: Principal Investigator: Jong Hae Kim, MD, Daegu Catholic University Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2018
• Primary Completion (Actual): August 8, 2019
• Study Completion (Actual): August 9, 2019

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: March 28, 2018
• First Posted (Actual): April 4, 2018

Study Record Updates

• Last Update Posted (Actual): August 12, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: 8th cervical nerve root block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID 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