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

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

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.

Study Overview

• Status: Completed
• Conditions: Post Surgical Pain
• Intervention / Treatment: Drug: Dexamethasone; Drug: Bupivacaine 0.25%; Drug: normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19139
      • Penn Presbyterian Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Dexamethasone; Drug: Bupivacaine 0.25%
Active Comparator: Bupivacaine 0.25% mixed with 2mg dexamethasone; Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)	Drug: Dexamethasone; Drug: Bupivacaine 0.25%
Active Comparator: Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml; Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml	Drug: Dexamethasone; Drug: Bupivacaine 0.25%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome Variable is Post Operative Sensory Block Duration	This is defined as time from the completion of the block to the initiation of supplemental analgesia medications after hospital discharge. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.	days 1, 2, and day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Secondary Outcome Variable is 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. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.	days 1, 2, and day 7

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Jiabin Liu, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: September 12, 2012
• First Submitted That Met QC Criteria: September 18, 2012
• First Posted (Estimate): September 24, 2012

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Bupivacaine
• Other Study ID Numbers: 815628