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

• ClinicalTrials.gov Identifier: NCT01690663
• Recruitment Status: Completed
• First Posted: September 24, 2012
• Results First Posted: May 4, 2017
• Last Update Posted: May 4, 2017
• Sponsor: University of Pennsylvania
• Information provided by (Responsible Party): University of Pennsylvania

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Post Surgical Pain	Drug: Bupivacaine 0.25%; Drug: Dexamethasone; Drug: normal saline	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 89 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: September 2012
• Actual Primary Completion Date: February 2015
• Actual Study Completion Date: February 2015

Arms and Interventions

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: 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

Outcome Measures

Primary Outcome Measures :

1. Primary Outcome Variable is Post Operative Sensory Block Duration [ Time Frame: days 1, 2, and day 7 ]
   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.

Secondary Outcome Measures :

1. The Secondary Outcome Variable is Post Operative Motor Block Duration [ Time Frame: days 1, 2, and day 7 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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
• Other Study ID Numbers: 815628
• First Posted: September 24, 2012
• Results First Posted: May 4, 2017
• Last Update Posted: May 4, 2017
• Last Verified: March 2017

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Dexamethasone; 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; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents