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

NCT ID: NCT02533557

Last Updated: 2016-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2015-12-31

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".

Conditions

Radius Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

stimuplex insulated needle

Intervention Type: DEVICE

2P2I group: nerve stimulating needle is advanced twice with the up-down direction at the different puncture site and LA is injected 15 mL at a time.

1P2I group: nerve stimulating needle is advanced twice with the up-down direction at the same puncture site and LA is injected 15 mL at a time.

lidocaine mixed with epinephrine

Intervention Type: DRUG

2P2I group and 1P2I 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) with the up-down direction at the different puncture site. 1P2I group is injected LA at equally divided doses with the up-down direction at the same puncture site.

1P2I 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 with a direction of upward at the same puncture site and penetrated the nerve sheath. If hand muscle twitching is observed at 0.3 mA, LA 15 mL is injected.

Group Type: ACTIVE_COMPARATOR

stimuplex insulated needle

Intervention Type: DEVICE

2P2I group: nerve stimulating needle is advanced twice with the up-down direction at the different puncture site and LA is injected 15 mL at a time.

1P2I group: nerve stimulating needle is advanced twice with the up-down direction at the same puncture site and LA is injected 15 mL at a time.

lidocaine mixed with epinephrine

Intervention Type: DRUG

2P2I group and 1P2I 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) with the up-down direction at the different puncture site. 1P2I group is injected LA at equally divided doses with the up-down direction at the same puncture site.

Interventions

stimuplex insulated needle

2P2I group: nerve stimulating needle is advanced twice with the up-down direction at the different puncture site and LA is injected 15 mL at a time.

1P2I group: nerve stimulating needle is advanced twice with the up-down direction at the same puncture site and LA is injected 15 mL at a time.

Intervention Type: DEVICE

lidocaine mixed with epinephrine

2P2I group and 1P2I 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) with the up-down direction at the different puncture site. 1P2I group is injected LA at equally divided doses with the up-down direction at the same puncture site.

Intervention Type: DRUG

Other Intervention Names

D Plus B.Braun; 1.5% lidocaine mixed with 1:200,000 epinephrine

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gachon University Gil Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mi Geum Lee

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mi Geum Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Medical Center

Locations

Department of Anesthesiology and Pain Medicine, Gachon University Gil Medical Center

Incheon, Guwol-dong, Namdong-gu, South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 24842181 (View on PubMed)

Other Identifiers

GBIRB2015-45

Identifier Type: -

Identifier Source: org_study_id