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NCT Number: NCT03487874

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

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.

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Key information

Conditions

Brachial Plexus Block Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional interscalene block

Procedure

Under ultrasound guidance, the 5th to 7th cervical nerve roots are blocked.

Interscalene block with C8 root block

Procedure

Under ultrasound guidance, the 5th to 8th cervical nerve roots are blocked.

0.75% Ropivacaine

Drug

Placement of 25 to 30 ml of 0.75% ropivacaine around the cervical nerve roots

Other names: Naropin

Primary outcomes

  1. Pain intensity upon the introduction of a posterior portal

    Time frame: 50 minutes after interscalene block

    0, 1, and 2 represent no pain, mild pain, and severe pain, respectively.

Secondary outcomes

  1. Sensory blockade

    Time frame: 30 minutes after interscalene block

    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

  2. Motor blockade

    Time frame: 30 minutes after interscalene block

    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)

  3. Ipsilateral hemidiaphragmatic blockade

    Time frame: Before interscalene block and 30 minutes after interscalene block

    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

  4. Horner's syndrome

    Time frame: Before interscalene block and 30 minutes after interscalene block

    The extent of a reduction in the ipsilateral pupil size measured by a pupillometer Presence or absence of ptosis

  5. Pulmonary function test

    Time frame: Before interscalene block and 30 minutes after interscalene block

    Forced expiratory volume at one second (FEV1) and FEV1/forced vital capacity before and 30 minutes after the end of local anesthetic injection

  6. Complications related with interscalene block

    Time frame: 24 hours

    Presence or absence of vascular puncture, local anesthetic systemic toxicity, pneumothorax, and paresthesia

  7. Numerical pain rating score at admission to postanesthetic care unit

    Time frame: 5 minutes

    Numerical pain rating score ranging from 0 to 10 (0 = no pain, 10 = worst pain imaginable) at admission to postanesthetic care unit

  8. Numerical pain rating score at discharge from postanesthetic care unit

    Time frame: 30 minutes

    Numerical pain rating score ranging from 0 to 10 (0 = no pain, 10 = worst pain imaginable) at discharge from postanesthetic care unit

  9. Numerical pain rating score between 6 and 12 hours after surgery

    Time frame: 6 and 12 hours

    Numerical pain rating score ranging from 0 to 10 (0 = no pain, 10 = worst pain imaginable) between 6 and 12 hours after surgery

  10. Numerical pain rating score 24 hours after surgery

    Time frame: 24 hours

    Numerical pain rating score ranging from 0 to 10 (0 = no pain, 10 = worst pain imaginable) 24 hours after surgery

  11. Worst numerical pain rating score

    Time frame: 24 hours

    Worst numerical pain rating score ranging from 0 to 10 (0 = no pain, 10 = worst pain imaginable) during 24 hours after surgery

  12. Postoperative hour when pain starts to be felt

    Time frame: 24 hours

    Time at regression of anesthesia which starts to cause postoperative pain during 24 hours after surgery

  13. Patient's satisfaction about surgical anesthesia and postoperative analgesia

    Time frame: 24 hours

    Likert scale consisting of "very dissatisfied", "dissatisfied", "unsure", "satisfied", and "very satisfied"

  14. Dose of postoperative analgesic use

    Time frame: 24 hours

    Cumulative dose of analgesic required for postoperative analgesia during 24 hours after surgery

  15. Frequency of postoperative analgesic use

    Time frame: 24 hours

    Frequency of analgesic use during 24 hours after surgery

  16. Dose of intraoperative analgesic use

    Time frame: 2 hours

    Cumulative dose of analgesic to supplement incomplete surgical anesthesia

  17. Frequency of intraoperative analgesic use

    Time frame: 2 hours

    Frequency of analgesic use to supplement incomplete surgical anesthesia

  18. Conversion into general anesthesia

    Time frame: 1 hour

    Number of patients whose regional anesthesia is converted into general anesthesia due to incomplete surgical anesthesia provided by the regional anesthesia

Sponsors and collaborators

Lead sponsor

Daegu Catholic University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 4, 2018
Registry last updated
Aug 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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