NCT02323282

Brief Summary

To determine the median effective concentration of ropivacaine hydrochloride for ultrasound-guided supraclavicular brachial plexus block. The result can provide reference for choosing appropriate drug concentration in clinical anesthesia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
Last Updated

December 23, 2014

Status Verified

October 1, 2014

Enrollment Period

2 months

First QC Date

October 5, 2014

Last Update Submit

December 18, 2014

Conditions

Anesthesia

Keywords

Dose-response relationshipDrug

Outcome Measures

Primary Outcomes (1)

  • the affection of nerve block

    The anesthetic efficacy of five nerves, respectively named lateral antebrachial cutaneous nerve, medial cutaneous nerve of the forearm, radial nerve, median nerve, and ulnar nerve was assessed within 30 min after anesthesia. The next concentration of ropivacaine was adjusted according to the response of the previous patient using up-down sequential allocation.

    30 minutes

Study Arms (1)

ropivacine

OTHER
Drug: ropivacaine

Interventions

ropivacaineDRUG
ropivacine

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I or II

You may not qualify if:

  • upper limb paresthesia
  • allergic to local anesthetics
  • surgery history of clavicle
  • BMI\>30kg/m\^2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology,Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Shan Yu

CONTACT

86-18930173658shanyu800302@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The study of ropivacaine median effective concentration in ultrasound-guided supraclavicular brachial plexus block

Study Record Dates

First Submitted

October 5, 2014

First Posted

December 23, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 23, 2014

Record last verified: 2014-10

Locations

CN(1)