Clinical trial NCT03487874: 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
Overall status: COMPLETED
Phase: NA
Conditions: Brachial Plexus Block
Shoulder Pain
Keywords: 8th cervical nerve root block
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
First posted: 2018-04-04
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain intensity upon the introduction of a posterior portal
timeFrame: 50 minutes after interscalene block
Secondary outcomes:
measure: Sensory blockade
timeFrame: 30 minutes after interscalene block
measure: Motor blockade
timeFrame: 30 minutes after interscalene block
measure: Ipsilateral hemidiaphragmatic blockade
timeFrame: Before interscalene block and 30 minutes after interscalene block
measure: Horner's syndrome
timeFrame: Before interscalene block and 30 minutes after interscalene block
measure: Pulmonary function test
timeFrame: Before interscalene block and 30 minutes after interscalene block
measure: Complications related with interscalene block
timeFrame: 24 hours
measure: Numerical pain rating score at admission to postanesthetic care unit
timeFrame: 5 minutes
measure: Numerical pain rating score at discharge from postanesthetic care unit
timeFrame: 30 minutes
measure: Numerical pain rating score between 6 and 12 hours after surgery
timeFrame: 6 and 12 hours
measure: Numerical pain rating score 24 hours after surgery
timeFrame: 24 hours
measure: Worst numerical pain rating score
timeFrame: 24 hours
measure: Postoperative hour when pain starts to be felt
timeFrame: 24 hours
measure: Patient's satisfaction about surgical anesthesia and postoperative analgesia
timeFrame: 24 hours
measure: Dose of postoperative analgesic use
timeFrame: 24 hours
measure: Frequency of postoperative analgesic use
timeFrame: 24 hours
measure: Dose of intraoperative analgesic use
timeFrame: 2 hours
measure: Frequency of intraoperative analgesic use
timeFrame: 2 hours
measure: Conversion into general anesthesia
timeFrame: 1 hour
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
Study officials:
affiliation: Daegu Catholic University Medical Center
name: Jong Hae Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.