US-SCBPB: Comparison 1 Plane-1 Injection and 2 Plane-2 Injection Ultrasound-guided Supraclavicular Brachial Plexus Block

Sponsor

Gachon University Gil Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02505633

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

17.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ultrasound-guided supraclavicular brachial plexus block (US-SCBPB) has been a generalized regional anesthesia in upper extremity surgery. It is performed just above the clavicle, in which the neural cluster formed by the trunks or divisions of the brachial plexus is situated superolateral to the subclavian artery (SA).

In many approaches, corner pocket approach [deposit local anesthetic (LA) at the intersection of the SA, neural cluster, and the first rib] and cluster approach (direct deposit LA into the neural cluster after penetration of the sheath of brachial plexus) has been well known methods. And single or multiple injection techniques has been used with the above approaches.

Condition or Disease	Intervention/Treatment	Phase
Radius Fractures	Device: Stimuplex insulated needle Drug: lidocaine mixed with epinephrine	N/A

Detailed Description

In clinical practices, the investigators observed that the neural cluster was shown differently every person on the ultrasound image. Some neural cluster is shown as a typical round cluster of grapes lateral to the SA, in which, any approaches of US-SCBPB can be possible and good success rates are anticipated. But in many cases, neural cluster was shown in part lateral or superolateral to the SA like slightly-hated SA on the ultrasound image, and it passes posterior to the SA when the probe follows the path of the neural cluster along the SA. In that case, corner pocket approach is hard to apply due to the position of the neural cluster far away from the first rib, cluster approach increases chance of lopsided spreading of the LA, and multiple injection is also hard to apply due to narrow-shaped neural cluster. Therefore, we hypothesized that double injection in different plane (we call this new approach as a 2 plane-2 injection approach) would achieve an effect of a "tridimensionally administered LA", which is presented like shortening the onset time or increasing rate of all four nerves block compared with the existing cluster approach (the investigators call this as an 1 plane- 1 injection approach in this study).

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Official Title:

A Randomized Comparison Between 1 Plane - 1 Injection (Cluster Approach) and 2 Plane - 2 Injection Ultrasound-guided Supraclavicular Brachial Plexus Block (US-SCBPB) in Upper Extremity Surgery

Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 2P2I group subcutaneous injection is done widely. A nerve stimulating needle (Stimuplex insulated needle; D Plus B. Braun, Melsungen, Germany) attached to a nerve stimulator (Stimuplex HNS12; B. Braun, Melsungen, Germany) is advanced via an ultrasound in-plane approach. After the needle is penetrated the nerve sheath with a direction of downward, the nerve stimulator is then turned on. If hand muscle twitching is observed even at 0.3 mA, LA 15 mL (lidocaine mixed with epinephrine) is injected. After that, the stimulating needle is re-advanced at the behind site of the initial puncture site. And the needle is penetrated the nerve sheath with a direction of upward, and then the same process is performed and LA 15 mL is injected.	Device: Stimuplex insulated needle 2P2I group: nerve stimulating needle is advanced twice and LA is injected 15 mL at a time. 1P1I group: nerve stimulating needle is advanced once and LA is injected 30 mL. Other Names: (D Plus B.Braun) Drug: lidocaine mixed with epinephrine 2P2I group and 1P1I group use the same LA (1.5% lidocaine mixed with 1:200,000 epinephrine). But 2P2I group is injected LA at equally divided doses (15 mL at a time). 1P1I group is injected LA 30 mL at once. Other Names: 1.5% lidocaine mixed with 1:200,000 epinephrine
Active Comparator: 1P1I group After subcutaneous injection of 1 mL of 2% lidocaine, a nerve stimulating needle (Stimuplex insulated needle; D Plus B. Braun, Melsungen, Germany) attached to a nerve stimulator (Stimuplex HNS12; B. Braun, Melsungen, Germany) is advanced via an ultrasound in-plane approach from lateral to medial direction. After the needle is penetrated the nerve sheath, the nerve stimulator is then turned on, and the stimulation current starts at 0.5mA. If hand muscle twitching is observed even at 0.3 mA, local anesthetics 30 mL (lidocaine mixed with epinephrine) is injected.	Device: Stimuplex insulated needle 2P2I group: nerve stimulating needle is advanced twice and LA is injected 15 mL at a time. 1P1I group: nerve stimulating needle is advanced once and LA is injected 30 mL. Other Names: (D Plus B.Braun) Drug: lidocaine mixed with epinephrine 2P2I group and 1P1I group use the same LA (1.5% lidocaine mixed with 1:200,000 epinephrine). But 2P2I group is injected LA at equally divided doses (15 mL at a time). 1P1I group is injected LA 30 mL at once. Other Names: 1.5% lidocaine mixed with 1:200,000 epinephrine

Arm

Intervention/Treatment

Experimental: 2P2I group

subcutaneous injection is done widely. A nerve stimulating needle (Stimuplex insulated needle; D Plus B. Braun, Melsungen, Germany) attached to a nerve stimulator (Stimuplex HNS12; B. Braun, Melsungen, Germany) is advanced via an ultrasound in-plane approach. After the needle is penetrated the nerve sheath with a direction of downward, the nerve stimulator is then turned on. If hand muscle twitching is observed even at 0.3 mA, LA 15 mL (lidocaine mixed with epinephrine) is injected. After that, the stimulating needle is re-advanced at the behind site of the initial puncture site. And the needle is penetrated the nerve sheath with a direction of upward, and then the same process is performed and LA 15 mL is injected.

Device: Stimuplex insulated needle

2P2I group: nerve stimulating needle is advanced twice and LA is injected 15 mL at a time. 1P1I group: nerve stimulating needle is advanced once and LA is injected 30 mL.

Other Names:

(D Plus B.Braun)

Drug: lidocaine mixed with epinephrine

2P2I group and 1P1I group use the same LA (1.5% lidocaine mixed with 1:200,000 epinephrine). But 2P2I group is injected LA at equally divided doses (15 mL at a time). 1P1I group is injected LA 30 mL at once.

Other Names:

1.5% lidocaine mixed with 1:200,000 epinephrine

Active Comparator: 1P1I group

After subcutaneous injection of 1 mL of 2% lidocaine, a nerve stimulating needle (Stimuplex insulated needle; D Plus B. Braun, Melsungen, Germany) attached to a nerve stimulator (Stimuplex HNS12; B. Braun, Melsungen, Germany) is advanced via an ultrasound in-plane approach from lateral to medial direction. After the needle is penetrated the nerve sheath, the nerve stimulator is then turned on, and the stimulation current starts at 0.5mA. If hand muscle twitching is observed even at 0.3 mA, local anesthetics 30 mL (lidocaine mixed with epinephrine) is injected.

Device: Stimuplex insulated needle

2P2I group: nerve stimulating needle is advanced twice and LA is injected 15 mL at a time. 1P1I group: nerve stimulating needle is advanced once and LA is injected 30 mL.

Other Names:

(D Plus B.Braun)

Drug: lidocaine mixed with epinephrine

Other Names:

1.5% lidocaine mixed with 1:200,000 epinephrine

Outcome Measures

Primary Outcome Measures

rate of complete sensory blockade of all 4 nerves. [check 30 minutes after performing the block]
If the sensory on the site under the control of all 4 (median, radial, ulnar, musculocutaneous) nerves is checked as 0 (just feeling of touch or none ) separately, it is considered as a complete sensory block. the investigators compare the rate of complete sensory block with 2P2I group and 1P1I group.

Secondary Outcome Measures

the onset time [check 30 minutes after performing the block]
The investigators compare the onset time (time required to obtain of a sensory block at the surgical incision site) with 2P2I group and 1P1I group.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

all patients anticipating surgery of the wrist or hand with aged 18 to 80 years and an American Society of Anesthesiologists physical status (ASA) of I or II.

Exclusion Criteria:

patients with preexisting 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, breast-feeding and prior surgery in the supraclavicular region, BMI ≥ 35 kg/㎡, uncooperative patients and patients' refusal. an ultrasound view of the perfect circular neural cluster.