Clinical trial NCT02533557: Comparison 1 Plane-2 Injection and 2 Plane-2 Injection Ultrasound-guided Supraclavicular Brachial Plexus Block
Official title: A Randomized Comparison Between 1 Plane-2 Injection and 2 Plane-2 Injection Ultrasound-guided Supraclavicular Brachial Plexus Block (US-SCBPB) in Upper Extremity Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radius Fractures
Keywords: brachial plexus block
nerve stimulator
ultrasound
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The supraclavicular block can provide effective surgical anesthesia of the forearm and hand. There have been many different approaches to ultrasound-guided supraclavicular brachial plexus block (US-SCBPB) according to the needle injection site (e.g. corner pocket approach, cluster approach) or number of needling (single or double injection). Numerous studies demonstrates good results (e.g. faster onset time) when using double injections rather than single injection. But double injection does not guarantee complete sensory block because ulnar nerve tends to be spared by its anatomical location.

Detailed description: The investigators hypothesized that double injection in different plane (we call this new approach as a 2 plane-2 injection approach;2P2I) would overcome the weakness of the existing double injection in same plane (we call this approach as a 1 plane-2 injection approach;1P2I) like "ulnar nerve sparing effect", and could have a good results (e.g. shortening the onset time or increasing rate of all four nerves block). Because 2P2I can achieve an effect of a "tridimensionally administered LA", rather 1P2I only achieve an effect of a " two-dimensionally administered LA".

Eligibility criteria: Inclusion Criteria:

* all patients anticipating surgery of the wrist or hand
* age: 18 to 80 years
* American Society of Anesthesiologists physical status (ASA): I or II

Exclusion Criteria:

* neuropathy in the operated limb
* ASA greater than III
* coagulation disorders
* known allergy to local anesthetics
* local infection at the puncture site
* chronic obstructive pulmonary disease or respiratory failure
* pregnancy or breast-feeding
* prior surgery in the supraclavicular region
* BMI ≥ 35 kg/㎡
* uncooperative patients
* patients' refusal

Primary outcomes:
measure: rate of complete sensory blockade of all 4 nerves
timeFrame: check 30 minutes after performing the block at 5-minute intervals (from date of randomization until the date of first documented progression)
Secondary outcomes:
measure: the onset time
timeFrame: check 30 minutes after performing the block at 5-minute intervals(from date of randomization until the date of first documented progression)
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Gachon University Gil Medical Center
state: Guwol-dong, Namdong-gu
Study officials:
affiliation: Gachon University Gil Medical Center
name: Mi Geum Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Techasuk W, Gonzalez AP, Bernucci F, Cupido T, Finlayson RJ, Tran DQ. A randomized comparison between double-injection and targeted intracluster-injection ultrasound-guided supraclavicular brachial plexus block. Anesth Analg. 2014 Jun;118(6):1363-9. doi: 10.1213/ANE.0000000000000224.