Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25% (Dex Dose)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01690663
First received: September 12, 2012
Last updated: August 17, 2016
Last verified: August 2016
  Purpose
When used in conjunction with a local anesthetic, dexamethasone may prolong both the sensory and motor effects of high supraclavicular brachial plexus nerve block (SBP) in arthroscopic shoulder surgery. This study seeks to determine if there is a relationship between the duration of sensory and motor blockade in supraclavicular brachial plexus nerve blocks (SBP) when combined with increasing doses of dexamethasone.

Condition Intervention
Post Surgical Pain
Drug: Bupivacaine 0.25%
Drug: Dexamethasone
Drug: normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Dose 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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • The primary outcome variable is change in post operative sensory block duration. [ Time Frame: days 1, 2, and day 7 ] [ Designated as safety issue: No ]
    This is defined as time from the completion of the block to the initiation of supplemental analgesia medications after PACU discharge.


Secondary Outcome Measures:
  • The change in post operative motor block duration [ Time Frame: days 1, 2, and day 7 ] [ Designated as safety issue: No ]
    This is defined as time from the completion of the block to the time when patient is able to move his or her forearm and/or hands


Other Outcome Measures:
  • The total post operative opioid consumption from after surgery to 48 hours post operatively. [ Time Frame: first 48 hours ] [ Designated as safety issue: No ]
    This time frame includes immediately post operative to the 48-hour time point after surgery.


Enrollment: 80
Study Start Date: September 2012
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Bupivacaine 0.25% mixed with 1ml normal saline
Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)
Drug: Bupivacaine 0.25% Drug: normal saline
placebo
Active Comparator: Bupivacaine 0.25% with 1mg dexamethasone (1ml)
Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)
Drug: Bupivacaine 0.25% Drug: Dexamethasone
Active Comparator: Bupivacaine 0.25% mixed with 2mg dexamethasone
Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)
Drug: Bupivacaine 0.25% Drug: Dexamethasone
Active Comparator: Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml
Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml
Drug: Bupivacaine 0.25% Drug: Dexamethasone

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged 18 to 70 scheduled for primary shoulder arthroscopy who have already elected to receive and are eligible for regional anesthesia (brachial plexus nerve block) prior to consenting for study.
  2. Ability to sign informed consent.
  3. Ability to follow study protocol, and speak, read and write in English.
  4. Must have valid phone number for follow-up purpose.
  5. Must be able to receive all protocol medications to include the dexamethasone, ketorolac, hydromorphone, and percocet.

Exclusion Criteria:

  1. Patient younger than 18 years old and older than age 70
  2. Patient refusal to sign consent
  3. Chronic opioid use (defined as narcotic use longer than 3 months) as documented in patient's medical record
  4. Allergy to any of the protocol medications
  5. Patients with severe lung disease, contra lateral phrenic nerve injury, insulin-dependent diabetes, hepatic disease/failure, kidney disease/failure as documented in patient's medical record
  6. Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690663

Locations
United States, Pennsylvania
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19139
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Jiabin Liu, MD University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01690663     History of Changes
Other Study ID Numbers: 815628 
Study First Received: September 12, 2012
Last Updated: August 17, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Bupivacaine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents

ClinicalTrials.gov processed this record on August 23, 2016