CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 128 enrolled
Drug / intervention
Bupivacaine +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02506660
NCT02506660Phase 4Completed

Interscalene Block With Low-dose IV vs. Perineural Dexamethasone for Shoulder Arthroscopy

Hospital for Special Surgery, New York·interventional·Posted Jul 23, 2015·Updated Aug 29, 2018

In Brief

A Phase 4 clinical trial evaluating Bupivacaine, Perineural dexamethasone, and 3 other interventions for Pain and Shoulder Arthroscopy. Completed, enrolled 128 participants across 1 site.

Detailed Summary

Many patients undergoing ambulatory shoulder arthroscopy experience moderate to severe pain after surgery. Finding ways to minimize postoperative pain are ideal. Dexamethasone is a corticosteroid that is commonly used to prevent and/or treat nausea and inflammation. The addition of higher doses of dexamethasone to nerve blocks, which are injections of local anesthetics into the upper shoulder area, has been shown to prolong block duration and reduce pain. However, it is unclear whether the advantage of longer pain relief outweighs patient dissatisfaction with the prolonged feeling of a numb arm. Furthermore, recent studies have shown that systemic, intravenously administered dexamethasone may similarly reduce pain levels when compared with dexamethasone in the block. In our study, the investigators propose to examine the effect of low-dose IV versus block dexamethasone on interscalene block duration in patients undergoing shoulder arthroscopy. Most studies have used 4 mg or more. One study suggests that 1 mg may have the same effect as larger doses. Our aims are to determine whether the addition of low-dose dexamethasone to a local anesthetic in the block can prolong its duration, and whether there are differences in postoperative pain, consumption of painkillers, side effects, and satisfaction in patients who received IV or block dexamethasone. Patients (128 total) will be randomly assigned to either receive IV or block dexamethasone, and postoperative assessments (pain, painkiller use, side effects, block duration, satisfaction, complications) will be made via phone at 2, 3, 4 (if needed), and 7-10 days after surgery. Results from this study will reveal whether patients prefer the longer-duration analgesia that may be obtained with low-dose dexamethasone in the block.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 23, 2015
Enrollment StartAug 1, 2015
Primary CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.9 years ago

Interventions

Bupivacainedrug

Perineural dexamethasonedrug

Dexamethasone in nerve block

Intravenous dexamethasonedrug

Intravenous salinedrug

Perineural salinedrug

Saline in nerve block