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Nerve Stimulator Versus Ultrasound-guided Infraclavicular Block

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ClinicalTrials.gov Identifier: NCT02344615
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Chunwoo Yang, Cheju Halla General Hospital

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

Condition or disease Intervention/treatment Phase
Pain Procedure: NS-guided infraclavicular block Procedure: US-guided infraclavicular block Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Nerve Stimulator and Ultrasound-guided Infraclavicular Block for Upper Extremity Surgery
Study Start Date : May 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: NS-guided infraclavicular block
NS-guided infraclavicular block is performed using 35 ml of 0.5% ropivacaine.
Procedure: NS-guided infraclavicular block
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.

Experimental: US-guided infraclavicular block
US-guided infraclavicular block is performed using 35 ml of 0.5% ropivacaine.
Procedure: US-guided infraclavicular block
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 Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344615


Locations
Korea, Republic of
Cheju Halla General Hopsital
Jeju, Jeju self-governing province, Korea, Republic of, 670-744
Sponsors and Collaborators
Cheju Halla General Hospital
Investigators
Principal Investigator: Chunwoo Yang, MD Dept. of anesthesia and pain medicine, Cheju Halla General Hospital

Publications:
Responsible Party: Chunwoo Yang, Department of Anesthesiology and pain medicine, Cheju Halla General Hospital
ClinicalTrials.gov Identifier: NCT02344615     History of Changes
Other Study ID Numbers: ICB1
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Chunwoo Yang, Cheju Halla General Hospital:
nerve stimulator
ultrasound

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents