Intravenous Dexamethasone for Prolongation of Analgesia Following Supraclavicular Brachial Plexus Block for Shoulder Arthroscopy: A Randomized, Controlled, Phase IV Dose-Response Study
Overview
- Phase
- Phase 4
- Intervention
- IV Dexamethasone 6mg
- Conditions
- Shoulder Arthroscopy
- Sponsor
- Hospital for Special Surgery, New York
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Duration of Analgesia From a Supraclavicular Block Performed for Shoulder Arthroscopy
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Previous studies have confirmed that IV dexamethasone prolongs brachial plexus blocks. However, these studies only used fixed doses of IV dexamethasone at relatively high doses, which could potentially lead to increased glucose levels, delayed wound healing, and unintended side effects. There remains a paucity of research on the effective dose range of IV dexamethasone for the prolongation of supraclavicular blocks. The optimal dosage of IV dexamethasone for prolongation of analgesia vs. motor block prolongation from supraclavicular blocks in shoulder surgery has yet to be delineated.
Detailed Description
Numerous studies have confirmed that perineural dexamethasone prolongs bupivacaine and ropivacaine brachial plexus blocks by approximately 10 hours (from approx. 12 to 22 hours) without clinical evidence of toxicity. However, perineural toxicity in an animal model has raised concern about its use as a peripheral nerve block adjuvant. Moreover, recent studies suggest that high dose IV dexamethasone (810mg) prolongs analgesia to a similar degree as perineural dexamethasone for interscalene, supraclavicular and sciatic nerve blocks performed with ropivacaine and bupivacaine. However these studies only utilized fixed, high level doses of IV dexamethasone. Moreover, there remains a concern that high dose IV dexamethasone may lead to postoperative hyperglycemia and could possibly increase the risk of postoperative wound infection. Open surgery under general anesthesia has been shown to increase blood glucose levels with a peak at approximately 2 hours post-induction and results have been conflicting regarding whether or not IV dexamethasone causes greater increase. To the investigators' knowledge, it is not yet known if arthroscopic surgery under regional anesthesia triggers a similar increase in blood glucose levels and if this is impacted by administration of IV dexamethasone. The investigators aim to identify the duration of supraclavicular block prolongation that can be expected over a range of doses of IV dexamethasone. The investigators also seek to identify what association, if any, is noted between IV dexamethasone and changes in blood glucose levels after shoulder surgery with regional anesthesia and sedation. Finally, the investigators will collect data on side effects and postoperative complications, if any, in patients receiving a range of doses of IV dexamethasone.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing shoulder arthroscopy under regional anesthesia
Exclusion Criteria
- •General anesthesia
- •Contraindication to regional anesthesia
- •Pre-existing neuropathy in the surgical limb
- •Diabetes Mellitus
- •History of postoperative nausea and vomiting \&/ or motion sickness
- •Procedures involving biceps tenotomy
- •Peri-articular cocktail injections given intraoperatively to augment pain relief
- •Chronic pain (daily opioid and/or gabapentinoid use for 6 weeks)
- •Open surgical procedures
- •Corticosteroid injection within 1 month
Arms & Interventions
6mg IV Dexamethasone
6mg IV Dexamethasone
Intervention: IV Dexamethasone 6mg
0mg IV Dexamethasone
0mg IV Dexamethasone
Intervention: IV Saline
4mg IV Dexamethasone
4mg IV Dexamethasone
Intervention: IV Dexamethasone 4mg
8mg IV Dexamethasone
8mg IV Dexamethasone
Intervention: IV Dexamethasone 8mg
Outcomes
Primary Outcomes
Duration of Analgesia From a Supraclavicular Block Performed for Shoulder Arthroscopy
Time Frame: Day of Surgery until Post-Operative Day 3 (if the block persists)
Defined as time from block placement until "pain relief from the block completely wears off" in the operative shoulder.
Secondary Outcomes
- Duration of Motor Block From the Supraclavicular Block(Day of Surgery until Post-Operative Day 3 (if the block persists))
- Occurrence of Postoperative Neuropraxia(Post-Operative Day 21)
- Blood Glucose Levels(Day of Surgery - before and 1-hour and 2-hours after IV Dexamethasone administration)
- Occurrence of Postoperative Wound Infection(Post-Operative Day 21)
- Average Daily Pain Scores at Rest and With Movement(Day of Surgery until Post-Operative Day 3 (if the block persists))
- Worst Daily Pain Scores at Rest and With Movement(Day of Surgery until Post-Operative Day 3 (if the block persists))
- Patient Satisfaction With Postoperative Analgesia(Post-Operative Day 2 or Post-Operative Day 3 (if the block persists))
- Cumulative Daily Opioid Usage(Recovery Room until Post-Operative Day 3 (if block persists))