Analgesic Efficacy of Perineural Dexamethasone During Supraclavicular Block for Hand Surgery

September 9, 2014 updated by: Duke University

Analgesic Efficacy of Perineural Dexamethasone Added to Ropivacaine 0.5% With 1:400,000 Epinephrine During Single-injection Supraclavicular Block for Outpatient Hand Surgery

The purpose of this study is to determine whether the addition of dexamethasone prolongs analgesia when added to long-acting local anesthetic during single-injection supraclavicular block for outpatient hand surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The goal for pain control after surgery is to provide the best possible pain control for the longest period of time with the least amount of side effects. One type of pain medication is called local anesthetic, which is a numbing medication that is injected in the area surrounding nerves to block pain. This injection is called a nerve block. Ropivacaine is a local anesthetic that is commonly used for nerve blocks and will be used in this study. The effects of ropivacaine may last for 8 to 12 hours after surgery. Recent research studies have shown that adding a medication called dexamethasone (a steroid) may increase the time that the nerve block will provide pain control. The purpose of this study is to see if adding dexamethasone to ropivacaine and injecting this around the nerves during a supraclavicular brachial plexus block increases the duration of pain relief as compared to both placebo control and systemic control groups.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 18 years of age and older
  • Patients scheduled for elective outpatient hand surgery with same day discharge at the Duke Ambulatory Surgery Center

Exclusion Criteria:

  • Patients who refuse regional anesthesia
  • Patients in whom peripheral nerve block is contraindicated
  • Patients unable to sign/understand consent
  • Patients with significant language barriers who cannot comply with data collection process
  • Patients with known allergies to local anesthetics
  • Pregnancy
  • Chronic pain patients or patients requiring chronic opioid treatment
  • Patients with a history of diabetes
  • Patients with contraindication to steroid administration (allergy, chronic steroid use)

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ropivacaine + dexamethasone
This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.
Drug: Ropivacaine
Other Names:
  • Naropin
Drug: Dexamethasone
Placebo Comparator: ropivacaine + placebo
This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.
Other: Placebo
Drug: Ropivacaine
Other Names:
  • Naropin
Active Comparator: ropivacaine + dexamethasone + placebo
This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.
Other: Placebo
Drug: Ropivacaine
Other Names:
  • Naropin
Drug: Dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to First Analgesic Dose
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Stephen Melton, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

May 30, 2014

First Submitted That Met QC Criteria

May 30, 2014

First Posted (Estimate)

June 3, 2014

Study Record Updates

Last Update Posted (Estimate)

September 11, 2014

Last Update Submitted That Met QC Criteria

September 9, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00019301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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