Intravenous Dexamethasone on Supraclavicular Brachial Plexus Block for Shoulder Arthroscopy

NCT02688530 | Completed Phase 4 Results

• 1 other identifier: 2015-853
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Arthroscopy; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Duration of Motor Block From the Supraclavicular Block

  Day of Surgery until Post-Operative Day 3 (if the block persists)

• Blood Glucose Levels

  Day of Surgery - before and 1-hour and 2-hours after IV Dexamethasone administration

• Occurrence of Postoperative Neuropraxia

  Post-Operative Day 21

• Occurrence of Postoperative Wound Infection

  Post-Operative Day 21

• Average Daily Pain Scores at Rest and With Movement

  Day of Surgery until Post-Operative Day 3 (if the block persists)

Study Arms (4)

0mg IV Dexamethasone

PLACEBO COMPARATOR

0mg IV Dexamethasone

Drug: IV Saline

4mg IV Dexamethasone

EXPERIMENTAL

4mg IV Dexamethasone

Drug: IV Dexamethasone 4mg

6mg IV Dexamethasone

EXPERIMENTAL

6mg IV Dexamethasone

Drug: IV Dexamethasone 6mg

8mg IV Dexamethasone

EXPERIMENTAL

8mg IV Dexamethasone

Drug: IV Dexamethasone 8mg

Interventions

IV Saline DRUG

0mg IV Dexamethasone

IV Dexamethasone 4mg DRUG

4mg IV Dexamethasone

IV Dexamethasone 6mg DRUG

6mg IV Dexamethasone

IV Dexamethasone 8mg DRUG

8mg IV Dexamethasone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients undergoing shoulder arthroscopy under regional anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Sodium Chloride; Dexamethasone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Meghan Kirksey, MD, PhD
• Organization: Hospital for Special Surgery

Kirkseym@hss.edu

212-606-1206

Study Officials

• Meghan Kirksey, MD, PhD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: February 23, 2016
• Study Start: May 1, 2016
• Primary Completion: November 19, 2017
• Study Completion: November 19, 2017
• Last Updated: May 13, 2022
• Results First Posted: May 13, 2022

Record last verified: 2022-05

Locations

US (1)