NCT01975285

Brief Summary

The purpose of this research study to evaluate the effects of dexamethasone as an addition to peripheral nerve block (Put the nerve to sleep with Bupivacaine a numbing medication) on length of pain relief (analgesia), postoperative narcotic (opioids) requirements, pain scores, and patient satisfaction after foot and ankle procedures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_4

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

August 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 6, 2016

Completed
Last Updated

May 6, 2016

Status Verified

April 1, 2016

Enrollment Period

10 months

First QC Date

October 29, 2013

Results QC Date

January 26, 2016

Last Update Submit

April 6, 2016

Conditions

Foot and Ankle Procedures

Keywords

Pain managementPostoperative opioid requirementsPerioperative outcomesDexamethasoneAnesthetic adjuvantAnalgesic adjuvant

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain

    Postoperative pain will be measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No pain" and 10 indicates= The worst possible pain

    3 days

Secondary Outcomes (4)

  • Opioid Consumption

    3 days

  • Length of Analgesia

    3 days

  • Patient Satisfaction With Regional Nerve Block

    3 days

  • Patient Satisfaction With Pain Management

    3 days

Study Arms (2)

Dexamethasone group

ACTIVE COMPARATOR

Dexamethasone 4mg(1 ml) per 20cc

Drug: Dexamethasone

Saline group

PLACEBO COMPARATOR

Saline 1 ml per 20cc

Drug: Saline

Interventions

DexamethasoneDRUG

0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc

Also known as: Decadron
Dexamethasone group
SalineDRUG

0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc

Also known as: placebo
Saline group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients (30 per group) undergoing foot and ankle procedures
  • Willingness and ability to sign an informed consent document
  • No allergies to anesthetic or analgesic medications
  • American Society of Anesthesiologists (ASA)physical status Class I - III
  • Aged 18-90 years,either sex

You may not qualify if:

  • Refusal to participate in the study
  • Age\<18 or\> 90 years -
  • Contraindications to regional blockage including but not limited to:
  • Patient refusal to regional blockade
  • Infection at the site of needle insertion
  • Systemic infection
  • Bleeding diathesis or coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars Sinai Medical center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

DexamethasoneCalcium DobesilateSodium Chloride

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Roya Yumul, M.D., Ph.D.
Organization
Department of Anesthesiology at Cedars-Sinai Medical Center in Los Angeles
(Roya.Yumul@cshs.org)
310-423-5841

Study Officials

  • Roya Yumul, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Residency program director, Department of anesthesiology

Study Record Dates

First Submitted

October 29, 2013

First Posted

November 4, 2013

Study Start

August 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

May 6, 2016

Results First Posted

May 6, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will share

Locations

US(1)