Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25%

Post Surgical Pain Clinical Trial

— Dex Dose  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690663
• Other study ID #: 815628
• Status: Completed
• Phase: N/A
• First received: September 12, 2012
• Last updated: August 17, 2016
• Start date: September 2012
• Est. completion date: February 2015

Study information

• Verified date: August 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post Surgical Pain

Intervention

Drug:
• Bupivacaine 0.25%

• Dexamethasone

• normal saline
placebo

Locations

Country	Name	City	State
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The total post operative opioid consumption from after surgery to 48 hours post operatively.	This time frame includes immediately post operative to the 48-hour time point after surgery.	first 48 hours	No
Primary	The primary outcome variable is change in post operative sensory block duration.	This is defined as time from the completion of the block to the initiation of supplemental analgesia medications after PACU discharge.	days 1, 2, and day 7	No
Secondary	The change in post operative motor block duration	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	days 1, 2, and day 7	No