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

Hospital for Special Surgery (HSS) logo

Hospital for Special Surgery (HSS)

Status and phase

Completed
Phase 4

Conditions

Shoulder Arthroscopy
Pain

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02688530
2015-853

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

140 participants in 4 patient groups, including a placebo group

0mg IV Dexamethasone
Placebo Comparator group
Description:
0mg IV Dexamethasone
Treatment:
Drug: IV Saline
4mg IV Dexamethasone
Experimental group
Description:
4mg IV Dexamethasone
Treatment:
Drug: IV Dexamethasone 4mg
6mg IV Dexamethasone
Experimental group
Description:
6mg IV Dexamethasone
Treatment:
Drug: IV Dexamethasone 6mg
8mg IV Dexamethasone
Experimental group
Description:
8mg IV Dexamethasone
Treatment:
Drug: IV Dexamethasone 8mg

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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