N/A
N=89
Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25%
Post Surgical Pain
Bottom Line
View on ClinicalTrials.gov: NCT01690663 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Primary Outcome Variable is Post Operative Sensory Block Duration — 12.1; 22.3; 23.3; 21.2 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bupivacaine 0.25% (Drug); Dexamethasone (Drug); normal saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Outcome Variable is Post Operative Sensory Block Duration |
12.1; 22.3; 23.3; 21.2 | — |
| SECONDARY The Secondary Outcome Variable is Post Operative Motor Block Duration |
12.1; 21; 20.9; 19.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
- Ability to sign informed consent.
- Ability to follow study protocol, and speak, read and write in English.
- Must have valid phone number for follow-up purpose.
- Must be able to receive all protocol medications to include the dexamethasone, ketorolac, hydromorphone, and percocet.
Exclusion Criteria
- Patient younger than 18 years old and older than age 70
- Patient refusal to sign consent
- Chronic opioid use (defined as narcotic use longer than 3 months) as documented in patient's medical record
- Allergy to any of the protocol medications
- 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
- Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)
Data sourced from ClinicalTrials.gov (NCT01690663). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.