NCT01075503

Brief Summary

Brachial plexus block is a frequently used technique for upper extremity surgery. All present approaches and techniques have certain advantages and disadvantages. It's necessary to develop a new approach to brachial plexus block which 1) provides reliable anesthesia, 2) is easy to perform, 3) isn't restricted by posture, 4) provides extensive sensory distribution, 5) causes as few complications as possible, 6) easily place a secured catheter for post-operative analgesia. The investigators established the retrograde infraclavicular brachial plexus block approach. The investigators compared and verified the feasibility, efficacy and safety of this new approach with other classic approaches to brachial plexus block.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2008

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2010

Completed
Last Updated

February 25, 2010

Status Verified

February 1, 2010

Enrollment Period

1.6 years

First QC Date

February 22, 2010

Last Update Submit

February 24, 2010

Conditions

Keywords

SupraclavicularInterscaleneInfraclavicularBrachial plexus blockRopivacaine

Outcome Measures

Primary Outcomes (1)

  • Success rate of nerve sensory block

    30 minutes

Secondary Outcomes (1)

  • Success rate of motor block

    30 minutes

Study Arms (3)

retrograde infraclavicular

EXPERIMENTAL

Patients were received retrograde infraclavicular brachial plexus block.

Procedure: brachial plexus block

interscalene

ACTIVE COMPARATOR

Patients were received interscalene brachial plexus block.

Procedure: brachial plexus block

supraclavicular

ACTIVE COMPARATOR

Patients were received supraclavicular brachial plexus block.

Procedure: brachial plexus block

Interventions

0.5% Ropivacaine 40ml

Also known as: NAROPIN® 1.0%
interscaleneretrograde infraclavicularsupraclavicular

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA physical status Ⅰ\~Ⅱ
  • Scheduled for elective upper extremity surgery

You may not qualify if:

  • Age \<18 yr or \>60 yr
  • Body weight \<50kg or \>100kg
  • Serious brain, heart, lung, liver, kidney diseases or diabetes mellitus
  • Incapability or refusing to be enrolled
  • Infection at the site of puncture, skin ulcer
  • Coagulopathy
  • Contralateral phrenic nerve paralysis, contralateral recurrent laryngeal nerve paralysis or pneumothorax

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing jishuitan hospital

Beijing, 100035, China

Location

MeSH Terms

Interventions

Brachial Plexus Block

Intervention Hierarchy (Ancestors)

Nerve BlockAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Xiaoguang Zhang, MB

    Department of anesthesiology, Beijing jishuitan hospital, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 22, 2010

First Posted

February 25, 2010

Study Start

March 1, 2008

Primary Completion

October 1, 2009

Study Completion

January 1, 2010

Last Updated

February 25, 2010

Record last verified: 2010-02

Locations