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
|Condition or disease||Intervention/treatment||Phase|
|Pain||Procedure: NS-guided infraclavicular block Procedure: US-guided infraclavicular block||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
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.
- Duration of postoperative analgesia [ Time Frame: at 24h after surgery ]time from completion of local anesthetic injection until the first request for an analgesic
- block performance time [ Time Frame: at 30 min after block placement ]the time between the block needle insertion and needle withdrawal
- 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
- patient discomfort [ Time Frame: at 30 min after block placement ]pain score (0-10) during the procedure
- paresthesia [ Time Frame: at 30 min after block placement ]presence of paresthesia during the procedure
- 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)
- motor block of hand [ Time Frame: at 24h after surgery ]presence of motor block in the operated hand
- postoperative dysesthesia [ Time Frame: at 24h after surgery ]presence of any paresthesia in the operated extremity
- supplemental analgesia [ Time Frame: at 24h after surgery ]Rescue analgesia with 75 mg of IM diclofenac was available on demand.
- Pain score [ Time Frame: at 24h after surgery ]
- 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).
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
|Korea, Republic of|
|Cheju Halla General Hopsital|
|Jeju, Jeju self-governing province, Korea, Republic of, 670-744|
|Principal Investigator:||Chunwoo Yang, MD||Dept. of anesthesia and pain medicine, Cheju Halla General Hospital|