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Completed

NCT Number: NCT02344615

Nerve Stimulator Versus Ultrasound-guided Infraclavicular Block

The investigators compared the postoperative analgesia of nerve stimulator-guided and ultrasound-guided infraclavicular block for upper extremity surgery.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

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 Self-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 ultrasound-guided peripheral nerve block enhanced the postoperative analgesia for upper extremity surgery compared with nerve stimulator (NS) guidance.

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 upper extremity surgery

Exclusion criteria

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

Treatment and study plan

NS-guided infraclavicular block

Procedure

Patients received a standard single injection infraclavicular block using the lateral sagittal approach of Klaastad. The infraclavicular brachial plexus is identified using an insulated needle connected to a nerve stimulator. Placement of the needle is considered adequate if motor response of radial nerve in the hand or wrist is still present at 0.2 - 0.5mA. Ropivacaine 0.5% 35ml is used.

US-guided infraclavicular block

Procedure

Infraclavicular block is performed under ultrasound guidance. Linear probe is placed in a parasagittal positon below the clavicle medial to the coracoid process and adjusted to achieve a cross-sectional image of the axillary artery. Using in-plane technique, an 22-gauge insulated needle is advanced caudally and posteriorly to the axillary artery. Subsequently, 35 ml of 0.5% ropivacaine is incrementally 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. block performance time

    Time frame: at 30 min after block placement

    the time between the block needle insertion and needle withdrawal

  2. 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

  3. patient discomfort

    Time frame: at 30 min after block placement

    pain score (0-10) during the procedure

  4. paresthesia

    Time frame: at 30 min after block placement

    presence of paresthesia during the procedure

  5. onset time

    Time frame: until 30min after completion of local anesthetic

    complete block of sensory nerve (radial, ulnar, median, musculocutaneous, and medial antebrachial cutaneous nerve)

  6. motor block of hand

    Time frame: at 24h after surgery

    presence of motor block in the operated hand

  7. postoperative dysesthesia

    Time frame: at 24h after surgery

    presence of any paresthesia in the operated extremity

  8. supplemental analgesia

    Time frame: at 24h after surgery

    Rescue analgesia with 75 mg of IM diclofenac was available on demand.

  9. Pain score

    Time frame: at 24h after surgery

  10. Patient satisfaction

    Time frame: at 24h after surgery

    The acceptance of the anesthetic technique 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 and Ultrasound-guided Infraclavicular Block for Upper Extremity Surgery

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 26, 2015
Registry last updated
Jan 28, 2016

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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