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Dexamethasone and Lower Extremity Block Duration

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01756586
Enrollment
4
Registered
2012-12-27
Start date
2013-02-28
Completion date
2014-12-31
Last updated
2017-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia Duration

Keywords

popliteal block, analgesia duration

Brief summary

Dexamethasone has shown to prolong upper extremity blocks. No one ha studied its effect on lower extremity blocks. The study would evaluate that point.

Interventions

DRUGDexamethasone
DRUGBupivacaine

Control

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Age 18-75 2. foot surgery 3. no contraindication to regional anesthesia

Exclusion criteria

1. opioid dependent 2. chronic pain condition 3. peripheral neuropathy

Design outcomes

Primary

MeasureTime frame
Increase in the Duration of Block3 days

Countries

United States

Participant flow

Participants by arm

ArmCount
Control
Plain bupivacaine Bupivacaine: Control
2
Experimental
Bupivacaine with Dexamethasone Dexamethasone Bupivacaine: Control
2
Total4

Baseline characteristics

CharacteristicControlExperimentalTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
2 Participants2 Participants4 Participants
Region of Enrollment
United States
2 participants2 participants4 participants
Sex: Female, Male
Female
1 Participants1 Participants2 Participants
Sex: Female, Male
Male
1 Participants1 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 20 / 2
serious
Total, serious adverse events
0 / 20 / 2

Outcome results

Primary

Increase in the Duration of Block

Time frame: 3 days

Population: Did not have resources to follow up with the subjects after the surgery. The study was terminated early.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026