NCT03377985

Brief Summary

The current study focused on ultrasound guided brachial plexus block (BPB) which plays an important role in patients with hand trauma either in pain control or for surgical intervention. The brachial plexus can be blocked by several techniques but the most commonly used are the supraclavicular (SCB) and axillary (AXB) blocks. Aim of this study is to compare between the two techniques as regard performance time, needling time, anesthesia related time, block related complications, number of needle pass, and block related pain. 80 patients were allocated randomly into two equal groups, under ultrasound guidance the SCB and AXB were done for the two groups respectively. The needling time, performance time, anesthesia related time, onset time, number of 1st needle pass in each group and block related complications were noted.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

12 months

First QC Date

December 7, 2017

Last Update Submit

December 17, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • block related complications

    failed block, motor weakness 24 h after the block, vascular puncture, Horner syndrome, paresthesia and pneumothorax

    24 hours after the block

Secondary Outcomes (1)

  • number of first needle pass

    10-20 min

Study Arms (2)

axillary brachial plexus block group

ACTIVE COMPARATOR

Patients placed in the supine position with arm to be blocked abducted and externally rotated. After sterilization of the axilla ultrasound device with high frequency of 8-12 MHZ, linear transducer was put parallel to the anterior axillary fold at axilla to identify the axillary artery, lateral, medial and posterior cords of the brachial plexus in relation to the axillary artery. Lidocaine 1% was infiltrated subcutaneously 1 cm lateral to the probe, 7-10 ml of bupivacaine 0.5% was injected around each cord of the brachial plexus

Procedure: brachial plexus block

supraclavicular brachial plexus block group

ACTIVE COMPARATOR

patients placed in the supine position with the head of the bed elevated 30 degrees and patient's head turned away from the side to be blocked after skin disinfection, ultrasound device was put transversely parallel to and above the middle third of the clavicle, the probe was tilted till identification of the subclavian artery, 1st rib, pleura and brachial plexus lateral to the subclavian artery and above the 1st rib. Lidocaine 1% was infiltrated subcutaneously 1 cm lateral to the lateral side of the probe. A needle was inserted in plane 1 cm lateral to the probe when adjacent to brachial plexus 25 ml of bubivacaine 0.5% was injected around the brachial plexus

Procedure: brachial plexus block

Interventions

Also known as: nerve block
axillary brachial plexus block groupsupraclavicular brachial plexus block group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with ASA physical status II and III, and body mass index (BMI) between 20 and 35, aged 40-70, undergoing emergency crushed hand surgery

You may not qualify if:

  • Patients with significant coagulopathy, infection or trauma at the injection site of local anesthetics, allergy to local anesthetics, refusal to participate, known neuropathies patients, mentally retarded patients, severely trauma patients who required general anesthesia from the start in the pre-induction room, and unconscious patients due to the accident. Also, shocked patients and patients with chronic obstructive airway disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Brachial Plexus BlockNerve Block

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 19, 2017

Study Start

January 1, 2016

Primary Completion

December 30, 2016

Study Completion

December 30, 2016

Last Updated

December 19, 2017

Record last verified: 2017-12