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Completed

NCT Number: NCT02342873

Nerve Stimulator Versus Ultrasound-guided Interscalene Block for Shoulder Surgery

The investigators compared the postoperative analgesia of nerve stimulator-guided and ultrasound-guided interscalene block after shoulder surgery.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cheju Halla General Hopsital

Jeju City, Jeju Special Governing Province, 670-744, South Korea

About this study

Ultrasound (US)-guided peripheral nerve block has increased in popularity. It has many advantages such as improved success rate, faster onset time, fewer needle passes, shorter performance time, and reduced procedural pain and vascular puncture. However, there is no information about postoperative analgesia.

Therefore, the investigators tested whether nerve stimulator (NS) - guided interscalene block was inferior to ultrasound-guided block in terms of duration of postoperative analgesia for shoulder surgery.

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 class I - III patients scheduled to undergo shoulder surgery

Exclusion criteria

  • coagulopathy, severe pulmonary disease, neuropathy, contralateral diaphragmatic paresis, allergy to study medications

Treatment and study plan

NS-guided interscalene block

Procedure

Patients received a standard single injection interscalene block using the modified lateral approach of Borgeat. The interscalene brachial plexus was identified using an insulated needle connected to a nerve stimulator. An insulated needle attached to a nerve stimulator was used to identify the brachial plexus. Placement of the needle was considered adequate if the deltoid, triceps, pectoralis, or biceps muscle motor response was still present at 0.2 - 0.5mA. Ropivacine 0.75% 20ml was used.

US-guided interscalene block

Procedure

Interscalene block is performed under ultrasound guidance. Linear probe is placed on the ipsilateral interscalene groove visualizing the brachial plexus located between anterior and middle scalene muscles. Using in-plane technique, an insulated needle is advanced into the brachial plexus sheath, into which 20 ml of 0.75% ropivacaine is injected

Primary outcomes

  1. duration of postoperative analgesia

    Time frame: at 24h after surgery

    time from completion of local anesthetic injection until the first request for an analgesic

Secondary outcomes

  1. onset time (complete block of sensory and motor nerve)

    Time frame: until 30min after completion of local anesthetic

    complete block of sensory and motor nerve

  2. patient discomfort (pain score (0 -10) during the procedure)

    Time frame: at 30 min after block placement

    pain score (0 -10) during the procedure

  3. block performance time (the time between the block needle insertion and needle withdrawal)

    Time frame: at 30 min after block placement

    the time between the block needle insertion and needle withdrawal.

  4. The number of needle redirections

    Time frame: at 30 min after block placement

    either forward or backward movement of needle at least 1 cm or more

  5. paresthesia (presence of paresthesia during the procedure)

    Time frame: at 30 min after block placement

    presence of paresthesia during the procedure

  6. motor block of hand

    Time frame: at 30 min after block placement

    degree of motor block in the operated hand

  7. paresthesia of hand

    Time frame: at 30 min after block placement

    presence of paresthesia in the operated hand

  8. Supplemental analgesia

    Time frame: at 24h after surgery

  9. Pain score

    Time frame: at 24h after surgery

    numerical rating scale (0 - 10)

  10. Patient satisfaction

    Time frame: at 24h after surgery

    Patient satisfaction was evaluated using a two-point score: 1, satisfactory (if necessary, I would have the same anesthetic technique); and 2, unsatisfactory (different anesthetic technique).

Sponsors and collaborators

Lead sponsor

Cheju Halla General Hospital

Other

Registry information

Official study title

A Randomized Comparison of Nerve Stimulator-guided and Ultrasound-guided Interscalene Block for Shoulder Surgery

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 21, 2015
Registry last updated
Jul 17, 2017

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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