An interventional study of Conventional interscalene block and Interscalene block with C8 root block in Brachial Plexus Block and Shoulder Pain, sponsored by Daegu Catholic University Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-12.
Sponsored by Daegu Catholic University Medical Center · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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 · Drug: 0.75% ropivacaine
The 5th to 7th cervical nerve root block under ultrasound guidance using 25 to 30 ml of 0.75% ropivacaine
Procedure: Conventional interscalene block · Drug: 0.75% ropivacaine
Under ultrasound guidance, the 5th to 7th cervical nerve roots are blocked.
Under ultrasound guidance, the 5th to 8th cervical nerve roots are blocked.
Placement of 25 to 30 ml of 0.75% ropivacaine around the cervical nerve roots
Also known as: Naropin
Pain intensity upon the introduction of a posterior portal
0, 1, and 2 represent no pain, mild pain, and severe pain, respectively.
Time frame: 50 minutes after interscalene block
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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 hours
Patient's satisfaction about surgical anesthesia and postoperative analgesia
Likert scale consisting of "very dissatisfied", "dissatisfied", "unsure", "satisfied", and "very satisfied"
Time frame: 24 hours
Dose of postoperative analgesic use
Cumulative dose of analgesic required for postoperative analgesia during 24 hours after surgery
Time frame: 24 hours
Frequency of postoperative analgesic use
Frequency of analgesic use during 24 hours after surgery
Time frame: 24 hours
Dose of intraoperative analgesic use
Cumulative dose of analgesic to supplement incomplete surgical anesthesia
Time frame: 2 hours
Frequency of intraoperative analgesic use
Frequency of analgesic use to supplement incomplete surgical anesthesia
Time frame: 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
Time frame: 1 hour
Plan to share: No
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Daegu Catholic University Medical Center