Intravenous Dexamethasone on Supraclavicular Brachial Plexus Block for Shoulder Arthroscopy

Phase 4

Completed

Conditions: Shoulder Arthroscopy
Pain

Interventions: Drug: IV Saline
Drug: IV Dexamethasone 4mg
Drug: IV Dexamethasone 6mg
Drug: IV Dexamethasone 8mg

Registration Number: NCT02688530

Lead Sponsor: Hospital for Special Surgery, New York

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 140

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
Patients on systemic oral or IV steroid therapy within 6 months

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0mg IV Dexamethasone	IV Saline	0mg IV Dexamethasone
4mg IV Dexamethasone	IV Dexamethasone 4mg	4mg IV Dexamethasone
6mg IV Dexamethasone	IV Dexamethasone 6mg	6mg IV Dexamethasone
8mg IV Dexamethasone	IV Dexamethasone 8mg	8mg IV Dexamethasone

Primary Outcome Measures

Name	Time	Method
Duration of Analgesia From a Supraclavicular Block Performed for Shoulder Arthroscopy	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 Outcome Measures

Name	Time	Method
Duration of Motor Block From the Supraclavicular Block	Day of Surgery until Post-Operative Day 3 (if the block persists)	Defined as the time from block placement to restoration of normal strength at both the wrist and elbow.
Occurrence of Postoperative Neuropraxia	Post-Operative Day 21	Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit.
Blood Glucose Levels	Day of Surgery - before and 1-hour and 2-hours after IV Dexamethasone administration	Fingerstick blood glucose test to be administered before and 1-hour and 2-hours after IV dexamethasone administration.
Average Daily Pain Scores at Rest and With Movement	Day of Surgery until Post-Operative Day 3 (if the block persists)	Using the Numeric Rating Scale (NRS) Pain obtained by patient interview. Lower numbers represent less pain and better outcomes. The scale range is from 0 (no pain) to 10 (worst pain possible).
Occurrence of Postoperative Wound Infection	Post-Operative Day 21	Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit.
Worst Daily Pain Scores at Rest and With Movement	Day of Surgery until Post-Operative Day 3 (if the block persists)	Using the numeric pain rating scale (NRS), will be obtained by patient interview. Lower numbers represent less pain and better outcomes. The scale range is from 0 (no pain) to 10 (worst pain possible).
Patient Satisfaction With Postoperative Analgesia	Post-Operative Day 2 or Post-Operative Day 3 (if the block persists)	Patient satisfaction with postoperative analgesia will be obtained by patient interview. Lower numbers represent worse outcomes. The scale range is from 0 (worst) to 10 (best).
Cumulative Daily Opioid Usage	Recovery Room until Post-Operative Day 3 (if block persists)	Dosages (reported in Morphine equivalent units) of opioid medication obtained by medical records and/or by patient interview.