Clinical trial NCT01690663: Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25%
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Surgical Pain
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2012-09-24
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Primary Outcome Variable is Post Operative Sensory Block Duration
timeFrame: days 1, 2, and day 7
Secondary outcomes:
measure: The Secondary Outcome Variable is Post Operative Motor Block Duration
timeFrame: days 1, 2, and day 7
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jiabin Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: