Intravenous Dexamethasone on Supraclavicular Brachial Plexus Block for Shoulder Arthroscopy (SCB & IV Dex)

Intravenous Dexamethasone for Prolongation of Analgesia Following Supraclavicular Brachial Plexus Block for Shoulder Arthroscopy: A Randomized, Controlled, Phase IV Dose-Response Study

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.

Study Overview

• Status: Completed
• Conditions: Pain; Shoulder Arthroscopy
• Intervention / Treatment: Drug: IV Saline; Drug: IV Dexamethasone 4mg; Drug: IV Dexamethasone 6mg; Drug: IV Dexamethasone 8mg

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital For Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 0mg IV Dexamethasone	Drug: IV Saline
Experimental: 4mg IV Dexamethasone	Drug: IV Dexamethasone 4mg
Experimental: 6mg IV Dexamethasone	Drug: IV Dexamethasone 6mg
Experimental: 8mg IV Dexamethasone	Drug: IV Dexamethasone 8mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Analgesia From a Supraclavicular Block Performed for Shoulder Arthroscopy	Defined as time from block placement until "pain relief from the block completely wears off" in the operative shoulder.	Day of Surgery until Post-Operative Day 3 (if the block persists)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Motor Block From the Supraclavicular Block	Defined as the time from block placement to restoration of normal strength at both the wrist and elbow.	Day of Surgery until Post-Operative Day 3 (if the block persists)
Blood Glucose Levels	Fingerstick blood glucose test to be administered before and 1-hour and 2-hours after IV dexamethasone administration.	Day of Surgery - before and 1-hour and 2-hours after IV Dexamethasone administration
Occurrence of Postoperative Neuropraxia	Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit.	Post-Operative Day 21
Occurrence of Postoperative Wound Infection	Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit.	Post-Operative Day 21
Average Daily Pain Scores at Rest and With Movement	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).	Day of Surgery until Post-Operative Day 3 (if the block persists)
Worst Daily Pain Scores at Rest and With Movement	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).	Day of Surgery until Post-Operative Day 3 (if the block persists)
Patient Satisfaction With Postoperative Analgesia	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).	Post-Operative Day 2 or Post-Operative Day 3 (if the block persists)
Cumulative Daily Opioid Usage	Dosages (reported in Morphine equivalent units) of opioid medication obtained by medical records and/or by patient interview.	Recovery Room until Post-Operative Day 3 (if block persists)

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Meghan Kirksey, MD, PhD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): November 19, 2017
• Study Completion (Actual): November 19, 2017

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: February 18, 2016
• First Posted (Estimate): February 23, 2016

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: 2015-853