Completed

Dex DoseDose Response Study of Dexamethasone in Combination With Bupivacaine 0.25% in Ultrasound Guided Supraclavicular Brachial Plexus Nerve Block, a Randomized, Placebo Controlled Prospective Clinical Trial

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Bupivacaine 0.25%

+ normal saline

+ Bupivacaine 0.25%

Drug
Who is being recruted

Neurologic Manifestations+4

+ Pain

+ Pathologic Processes

From 18 to 70 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorUniversity of Pennsylvania
Last updated: May 4, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

The exact mechanism of dexamethasone on peripheral nerve block is unclear. The current theory is that the effect is not dose related, while only 4mg and 8mg doses were studied. Our hypothesis is that the dose differences at 1mg, 2mg, or 4mg, does not have significant effect on the duration of analgesia. Therefore, we are not considering any patients to receive suboptimal dosing of preservative free dexamethasone in this study.

NCT01690663
Principal SponsorUniversity of Pennsylvania
Last updated: May 4, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

89 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainPathologic ProcessesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsPain, Postoperative

Criteria

5 inclusion criteria required to participate
Ability to follow study protocol, and speak, read and write in English
Ability to sign informed consent
Must be able to receive all protocol medications to include the dexamethasone, ketorolac, hydromorphone, and percocet
Must have valid phone number for follow-up purpose
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6 exclusion criteria prevent from participating
Allergy to any of the protocol medications
Chronic opioid use (defined as narcotic use longer than 3 months) as documented in patient's medical record
Patient refusal to sign consent
Patient younger than 18 years old and older than age 70
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)

Group II

Active Comparator
Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)

Group III

Active Comparator
Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)

Group IV

Active Comparator
Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Penn Presbyterian Medical Center

Philadelphia, United StatesOpen Penn Presbyterian Medical Center in Google Maps
CompletedOne Study Center