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

Shoulder Pain Clinical Trial

Official title:

Efficacy of the 8th Cervical Nerve Root Block During Interscalene Brachial Plexus Block for Arthroscopic Shoulder Surgery: Prospective Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487874
• Other study ID #: CR-18-018
• Status: Completed
• Phase: N/A
• Start date: April 4, 2018
• Est. completion date: August 9, 2019

Study information

• Verified date: August 2019
• Source: Daegu Catholic University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 9, 2019
• Est. primary completion date: August 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brachial Plexus Block
• Shoulder Pain

Intervention

Procedure:
• Conventional interscalene block
Under ultrasound guidance, the 5th to 7th cervical nerve roots are blocked.
• 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

Locations

Country	Name	City	State
Korea, Republic of	Daegu Catholic University Medical Center	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Daegu Catholic University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Complications related with interscalene block	Presence or absence of vascular puncture, local anesthetic systemic toxicity, pneumothorax, and paresthesia	24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient's satisfaction about surgical anesthesia and postoperative analgesia	Likert scale consisting of "very dissatisfied", "dissatisfied", "unsure", "satisfied", and "very satisfied"	24 hours
Secondary	Dose of postoperative analgesic use	Cumulative dose of analgesic required for postoperative analgesia during 24 hours after surgery	24 hours
Secondary	Frequency of postoperative analgesic use	Frequency of analgesic use during 24 hours after surgery	24 hours
Secondary	Dose of intraoperative analgesic use	Cumulative dose of analgesic to supplement incomplete surgical anesthesia	2 hours
Secondary	Frequency of intraoperative analgesic use	Frequency of analgesic use to supplement incomplete surgical anesthesia	2 hours
Secondary	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