NCT03940469

Brief Summary

The investigators compared between dexamethasone and dexmedetomidine when added to levobupivacaine in the quality and duration of ultrasound-guided interscalene block during shoulder arthroscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2016

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

2.5 years

First QC Date

April 10, 2019

Last Update Submit

May 6, 2019

Conditions

Postoperative AnalgesiaPostoperative Complications

Keywords

DexmedetomidineDexamethasoneInterscalene

Outcome Measures

Primary Outcomes (1)

  • Changes in postoperative analgesia

    Assessed by measuring severity of pain by visual analog score(score 0 to 10 cm with 0= no pain and 10=worst pain imaginable).

    During first 2 days after surgery

Secondary Outcomes (3)

  • Postoperative analgesic requirement

    During first 2 days after surgery

  • Hemodynamic parameter

    During first 2 days after surgery

  • Hemodynamic parameter

    During first 2 days after surgery

Study Arms (3)

Control group

PLACEBO COMPARATOR

received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block.

Drug: Saline

Dexamethasone group

ACTIVE COMPARATOR

received 35ml levobupivacaine+8mg dexamethasone

Drug: Dexamethasone Injection

Dexmeteomidine group

ACTIVE COMPARATOR

received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.

Drug: Dexmedetomidine Hydrochloride

Interventions

SalineDRUG

2 ml normal saline

Also known as: normal saline
Control group
Dexamethasone InjectionDRUG

8 mg dexamethasone

Also known as: dexamethsone
Dexamethasone group
Dexmedetomidine HydrochlorideDRUG

100 microgram dexmedetomidine

Also known as: dexmedetomidine
Dexmeteomidine group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Sixty healthy patients ASA I-II
  • Aged 18-60 years
  • Of both sexes
  • Scheduled for shoulder arthroscopy using ultrasound interscalene block were enrolled.

You may not qualify if:

  • Patients with a history of any allergic reactions to levobupivacaine, dexamethasone or α2 agonists
  • All patients with hypertension, cardiac, hepatic, renal or pulmonary diseases, - Patients who were under treatment by α2 agonist or antagonists
  • Pregnant women
  • Psychiatric patients
  • Patients with a previous history or clinical evidence of central or peripheral neurological disease
  • Coagulopathy or anticoagulant/antiaggregant therapy
  • Contralateral phrenic nerve paresis
  • Patients who have an infection at the site of the block.
  • Every patient who had an anatomical or vascular abnormality in the upper extremity were excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ashraf Eskandr

Shibīn al Kawm, Monufia Governorate, 1234, Egypt

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

Sodium ChlorideSaline SolutionCalcium DobesilateDexmedetomidine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • mamdouh e lotfy, m.d.

    emeritus professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
both the patients and the observer were blind to the treatment groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: three groups 20 each, Group C received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. Group H received 35ml levobupivacaine+8mg dexamethasone under ultrasound guided interscalene block. Group D received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia, ICU

Study Record Dates

First Submitted

April 10, 2019

First Posted

May 7, 2019

Study Start

July 3, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

May 7, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)