NCT01442558

Brief Summary

The aim of this study is to compare the quality of 3 methods of ultrasound-guided brachial plexus blocks for surgical anesthesia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 21, 2015

Status Verified

September 1, 2011

Enrollment Period

1.8 years

First QC Date

September 22, 2011

Last Update Submit

January 20, 2015

Conditions

Pain

Keywords

reliefIntra-operative

Outcome Measures

Primary Outcomes (1)

  • Quality of 3 different approaches to brachial plexus block

    Whether or not there is need for additional analgesic drugs or need to switch to general anesthesia

    Immediate

Study Arms (3)

SCL

ACTIVE COMPARATOR

Supraclavicular ultrasound-guided brachial plexus block

Drug: Bupivacaine

ICL

ACTIVE COMPARATOR

Infraclavicular ultrasound-guided brachial plexus block

Drug: Bupivacaine

AX

ACTIVE COMPARATOR

Axillary ultrasound-guided brachial plexus block

Drug: Bupivacaine

Interventions

BupivacaineDRUG

Bupivacaine 5 mg/cc with adrenaline 5 mcg/cc will be injected with complete spread of the drug around nerves.

AXICLSCL

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III physical status
  • Surgery of distal arm, forearm or hand

You may not qualify if:

  • Skin infection near block injection site
  • Allergy to local anesthetics
  • Peripheral neuropathy upper limb
  • INR of more than 1.4
  • Thrombocytopenia
  • Opioid dependency
  • Chronic pain syndrome
  • Lack of orientation to person, place and time
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Related Publications (1)

  • Stav A, Reytman L, Stav MY, Portnoy I, Kantarovsky A, Galili O, Luboshitz S, Sevi R, Sternberg A. Comparison of the Supraclavicular, Infraclavicular and Axillary Approaches for Ultrasound-Guided Brachial Plexus Block for Surgical Anesthesia. Rambam Maimonides Med J. 2016 Apr 19;7(2):e0013. doi: 10.5041/RMMJ.10240.

    PMID: 27101216DERIVED

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2011

First Posted

September 28, 2011

Study Start

December 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 21, 2015

Record last verified: 2011-09

Locations

IL(1)