NCT02102607

Brief Summary

The primary aim of this study was to determine the median effective dose (ED50) for motor block of intrathecally-administered ropivacaine in adults (20-80 years), and to assess the effect of age on ED50 required for motor block.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

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

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 27, 2015

Status Verified

October 1, 2015

Enrollment Period

1.2 years

First QC Date

March 24, 2014

Last Update Submit

October 23, 2015

Conditions

Keywords

intrathecal; ropivacaine; motor blockade; local anesthetics

Outcome Measures

Primary Outcomes (1)

  • the dose of intrathecal ropivacaine

    at 5-min after administered ropivacaine

Study Arms (1)

age

subjects stratified according to age: 20-30 years (Group 1), 31-40 years (Group 2), 41-50 years (Group 3), 51-60 years (Group 4), 61-70 years (Group 5), and 71-80 years (Group 6).

Other: age

Interventions

ageOTHER

subjects stratified according to age: 20-30 years (Group 1), 31-40 years (Group 2), 41-50 years (Group 3), 51-60 years (Group 4), 61-70 years (Group 5), and 71-80 years (Group 6).

age

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who were undergoing transurethral, urological or lower limb surgery, primarily under the spinal anesthesia

You may qualify if:

  • Adult patients who were undergoing transurethral, urological or lower limb surgery, primarily under the spinal anesthesia

You may not qualify if:

  • Patients with diabetes, obesity, neuromuscular diseases, bleeding diathesis, hypersensitivity to amide local anesthetics, lumbar vertebrae abnormality, chronic back pain, or who were pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Three Gorges University

Yichang, Hubei, 443003, China

Location

Related Publications (2)

  • Lee YY, Ngan Kee WD, Fong SY, Liu JT, Gin T. The median effective dose of bupivacaine, levobupivacaine, and ropivacaine after intrathecal injection in lower limb surgery. Anesth Analg. 2009 Oct;109(4):1331-4. doi: 10.1213/ane.0b013e3181b1912b.

    PMID: 19762766BACKGROUND
  • Gupta R, Bogra J, Singh PK, Saxena S, Chandra G, Kushwaha JK. Comparative study of intrathecal hyperbaric versus isobaric ropivacaine: A randomized control trial. Saudi J Anaesth. 2013 Jul;7(3):249-53. doi: 10.4103/1658-354X.115326.

    PMID: 24015125BACKGROUND

MeSH Terms

Interventions

Aging

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Study Officials

  • jun yang, PhD

    China Three Gorges University

    STUDY DIRECTOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
the First College of Clinical Medical Science, China Three Gorges University (China)

Study Record Dates

First Submitted

March 24, 2014

First Posted

April 3, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

June 1, 2015

Last Updated

October 27, 2015

Record last verified: 2015-10

Locations