Clinical trial NCT02342873: Nerve Stimulator Versus Ultrasound-guided Interscalene Block for Shoulder Surgery
Official title: A Randomized Comparison of Nerve Stimulator-guided and Ultrasound-guided Interscalene Block for Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: ultrasound
nerve stimulator
Lead sponsor: Cheju Halla General Hospital
Sponsor class: OTHER
First posted: 2015-01-21
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 nerve stimulator (NS) - guided interscalene block was inferior to ultrasound-guided block in terms of duration of postoperative analgesia for shoulder surgery.

Eligibility criteria: 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

Primary outcomes:
measure: duration of postoperative analgesia
timeFrame: at 24h after surgery
Secondary outcomes:
measure: onset time (complete block of sensory and motor nerve)
timeFrame: until 30min after completion of local anesthetic
measure: patient discomfort (pain score (0 -10) during the procedure)
timeFrame: at 30 min after block placement
measure: block performance time (the time between the block needle insertion and needle withdrawal)
timeFrame: at 30 min after block placement
measure: The number of needle redirections
timeFrame: at 30 min after block placement
measure: paresthesia (presence of paresthesia during the procedure)
timeFrame: at 30 min after block placement
measure: motor block of hand
timeFrame: at 30 min after block placement
measure: paresthesia of hand
timeFrame: at 30 min after block placement
measure: Supplemental analgesia
timeFrame: at 24h after surgery
measure: Pain score
timeFrame: at 24h after surgery
measure: Patient satisfaction
timeFrame: at 24h after surgery
Other outcomes:
Locations:
city: Jeju-si
country: Korea, Republic of
facility: Cheju Halla General Hopsital
state: Jeju special governing province
Study officials:
affiliation: Dep. of anesthesia and pain medicine, Cheju Halla General Hospital
name: Chunwoo Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi S, McCartney CJ. Evidence Base for the Use of Ultrasound for Upper Extremity Blocks: 2014 Update. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):242-50. doi: 10.1097/AAP.0000000000000155.
citation: Koscielniak-Nielsen ZJ. Ultrasound-guided peripheral nerve blocks: what are the benefits? Acta Anaesthesiol Scand. 2008 Jul;52(6):727-37. doi: 10.1111/j.1399-6576.2008.01666.x. Epub 2008 May 12.