Intravenous Dexamethasone on Supraclavicular Brachial Plexus Block for Shoulder Arthroscopy

NCT ID: NCT02688530

Last Updated: 2022-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-11-19

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.

Conditions

Shoulder Arthroscopy; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

0mg IV Dexamethasone

0mg IV Dexamethasone

Group Type: PLACEBO_COMPARATOR

IV Saline

Intervention Type: DRUG

4mg IV Dexamethasone

4mg IV Dexamethasone

Group Type: EXPERIMENTAL

IV Dexamethasone 4mg

Intervention Type: DRUG

6mg IV Dexamethasone

6mg IV Dexamethasone

Group Type: EXPERIMENTAL

IV Dexamethasone 6mg

Intervention Type: DRUG

8mg IV Dexamethasone

8mg IV Dexamethasone

Group Type: EXPERIMENTAL

IV Dexamethasone 8mg

Intervention Type: DRUG

Interventions

IV Saline

Intervention Type: DRUG

IV Dexamethasone 4mg

Intervention Type: DRUG

IV Dexamethasone 6mg

Intervention Type: DRUG

IV Dexamethasone 8mg

Intervention Type: DRUG

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
• Patients on systemic oral or IV steroid therapy within 6 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meghan Kirksey, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015-853

Identifier Type: -

Identifier Source: org_study_id