Skip to main content
OpenTrials
Completed

NCT Number: NCT02688530

Intravenous Dexamethasone on Supraclavicular Brachial Plexus Block for Shoulder Arthroscopy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shoulder Arthroscopy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV Saline

Drug

IV Dexamethasone 4mg

Drug

IV Dexamethasone 6mg

Drug

IV Dexamethasone 8mg

Drug

Primary outcomes

  1. 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

  1. Duration of Motor Block From the Supraclavicular Block

    Time frame: 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.

  2. Blood Glucose Levels

    Time frame: 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.

  3. Occurrence of Postoperative Neuropraxia

    Time frame: 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.

  4. Occurrence of Postoperative Wound Infection

    Time frame: 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.

  5. Average Daily Pain Scores at Rest and With Movement

    Time frame: 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).

  6. Worst Daily Pain Scores at Rest and With Movement

    Time frame: 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).

  7. Patient Satisfaction With Postoperative Analgesia

    Time frame: 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).

  8. Cumulative Daily Opioid Usage

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Acronym: SCB & IV Dex

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 23, 2016
Registry last updated
May 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.