NCT04714112

Brief Summary

Dexamethasone has been tested as an effective adjuvant to prolong the effect of local anesthetics for peripheral nerve blocks, both perineurally and intravenously. The purpose of this study is to investigate the effect of the addition of dexamethasone (5mg) at different time to a standard ropivacaine solution (0.5%) on analgesic duration of interscalene block.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

January 15, 2021

Last Update Submit

January 25, 2023

Conditions

AnalgesiaDexamethasoneBrachial Plexus BlockIntravenous Drug UsageTimeShoulder Surgery

Outcome Measures

Primary Outcomes (1)

  • Duration of sensory block

    from completion of ISB to VAS for pain \> 0 ( in hours)

    one day postoperative

Secondary Outcomes (7)

  • Time to First Opioid Consumption

    one day postoperative

  • Opioid Consumption

    two days postoperative

  • Visual Analog Scale for pain ( from 0 to 10 )

    7 days postoperative

  • Postoperative Serum Blood Glucose

    one day postoperative

  • Infection

    7 days postoperative

  • +2 more secondary outcomes

Study Arms (2)

preoperative group

EXPERIMENTAL

Intravenous dexamethasone (5mg) is used when ultrasound guided ISB is performed.

Drug: dexamethasone

postoperative group

ACTIVE COMPARATOR

Ultasound guided ISB is performed before operation and intravenous dexamethasone (5mg) is used in postoperative care unit ( PACU)

Drug: dexamethasone

Interventions

dexamethasoneDRUG

Intravenous administration of dexamethasone at different time for the duration of ISB with 0.5% ropivacaine

Also known as: Dexamethasone Dexamethasone sodium phosphate
postoperative grouppreoperative group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing arthroscopic shoulder surgery at Shanghai Sixth People's Hospital.
  • ASA functional status class I to II
  • Age 18 to 70 years
  • BMI ≤ 35 kg/m2

You may not qualify if:

  • Lack of patient consent
  • Allergy to dexamethasone or ropivacaine
  • BMI \> 35 kg/m2
  • Contraindications to low dose dexamethasone including peptic ulcer disease, systemic infection, glaucoma, active varicella/herpetic infections, diabetes mellitus
  • Contraindications to ISB including severe Chronic Obstructive Pulmonary Disease (Forced expiratory volume \< 40% predicted), coagulopathy, pre-existing neurologic deficit in ipsilateral upper extremity, localized infection
  • Pregnant or nursing females
  • Chronic opioid use defined as \> 30mg oral morphine or equivalent per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Agnosia

Interventions

Dexamethasonedexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Quanhong Zhou, MD., Ph.D

    Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 15, 2021

First Posted

January 19, 2021

Study Start

January 10, 2021

Primary Completion

May 31, 2021

Study Completion

July 31, 2021

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)