NCT02151487

Brief Summary

The aim of this randomized, observer-blinded study is to evaluate the postoperative analgesic efficacy of adding dexamethasone and clonidine to ropivacaine in supraclavicular nerve block. The investigators hypothesized that addition of dexamethasone and clonidine to ropivacaine would prolong the duration of analgesia in supraclavicular nerve block compared with ropivacaine alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Typical duration for all trials

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

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2016

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

July 5, 2019

Completed
Last Updated

July 5, 2019

Status Verified

April 1, 2019

Enrollment Period

2.1 years

First QC Date

May 28, 2014

Results QC Date

April 20, 2018

Last Update Submit

April 15, 2019

Conditions

Upper Extremity Surgery

Keywords

Supraclavicular blockRopivacaineDexamethasoneClonidinePostoperative analgesia

Outcome Measures

Primary Outcomes (1)

  • Duration of the Sensorial Supraclavicular Block

    Duration of sensorial block defined as the time interval between subject admitted to the Post-Anesthesia Care Unit and the time the first pain medication taken at home

    within 24-hr after surgery

Secondary Outcomes (1)

  • Postoperative Analgesia

    within 15 minutes at postanesthesia care unit (PACU) arrival

Study Arms (4)

Ropivacaine

Ropivacaine 0.5% 25 ml alone for supraclavicular block

Drug: Ropivacaine

Ropivacaine and dexamethasone

25 ml 0.5% ropivacaine + 4 mg dexamethasone

Drug: Ropivacaine and dexamethasone

Ropivacaine and clonidine

25 ml 0.5% ropivacaine + 100 mcg clonidine

Drug: Ropivacaine and clonidine

Ropivacaine, dexamethasone and clonidine

25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine

Drug: Ropivacaine, dexamethasone and clonidine

Interventions

RopivacaineDRUG

Ropivacaine alone

Also known as: Noropin
Ropivacaine
Ropivacaine and dexamethasoneDRUG

Ropivacaine combination with dexamethasone

Also known as: Noropin and adjuvant
Ropivacaine and dexamethasone
Ropivacaine and clonidineDRUG

Ropivacaine combination with clonidine

Also known as: Noropin and adjuvants
Ropivacaine and clonidine
Ropivacaine, dexamethasone and clonidineDRUG

Ropivacaine combination with dexamethasone and clonidine

Also known as: Noropin and adjuvants
Ropivacaine, dexamethasone and clonidine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects who scheduled to undergo upper extremity surgery requiring USSB for postoperative analgesia with ropivacaine alone or ropivacaine and adjuvants.

You may qualify if:

  • Men and women 18-80 years old
  • Undergoing upper extremity surgery
  • Receiving Supraclavicular block
  • Receiving ropivacaine, ropivacaine adjuvants (dexamethasone, clonidine) for the supraclavicular nerve block.
  • Able to give Informed consent

You may not qualify if:

  • Age less than 18 and greater than 80 years
  • Inability to understand the study procedures
  • Significant respiratory dysfunction
  • Preexisting neurologic deficits
  • Allergy to local anesthetics
  • A bleeding diathesis or on anticoagulants
  • Systemic glucocorticoid use
  • Refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parkland Health Hospital System

Dallas, Texas, 750390, United States

Location

MeSH Terms

Interventions

RopivacaineDexamethasoneAdjuvants, PharmaceuticClonidine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedPharmaceutic AidsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and UsesImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dawood Nasir
Organization
UT Southwestern Medical Center
Dawood.Nasir@UTSouthwestern.edu
214-590-5352

Study Officials

  • Dawood Nasir, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 28, 2014

First Posted

May 30, 2014

Study Start

March 1, 2014

Primary Completion

April 1, 2016

Study Completion

August 20, 2016

Last Updated

July 5, 2019

Results First Posted

July 5, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)