Duration of Analgesia With Dexmedetomidine and Ropivacaine in Brachial Plexus Block

NCT03385967 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: IRB201702926
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, randomized, double blind study of adding dexmedetomidine to ropivacaine for Brachial plexus block and assessing the analgesia with VAS pain scales(0-10), Satisfaction scale by VAS scale(0-10) and time to first analgesic consumption. This study mainly aims to investigate whether addition of dexmedetomidine helps in increasing the duration of analgesia.

Conditions

Analgesia; Pain, Acute; Peripheral Nerve Block

Keywords

upper extremity bone fracture

Outcome Measures

Primary Outcomes (1)

• Duration of Effect

  To determine the change in duration of analgesia by the time to first intake of analgesic medicine by adding 0.25mcg/kg of dexmedetomidine to 25 ml of 0.5%ropivacaine in Brachial plexus nerve block.

  Immediate pre-op until 36hours post block

Secondary Outcomes (1)

• Potential Side Effects

  Immediate pre-op until 36hours post block

Study Arms (2)

ropivacaine only

ACTIVE COMPARATOR

0.5% ropivacaine

Drug: ropivacaine

ropivacaine with dexmedetomidine

ACTIVE COMPARATOR

25ml of 0.5%ropivacaine with 0.25mcg/kg of dexmedetomidine

Drug: Dexmedetomidine; Drug: ropivacaine

Interventions

Dexmedetomidine DRUG

Addition of Dexmedetomidine in block .25mcg/kg of dexmedetomidine

Also known as: precedex

ropivacaine with dexmedetomidine

ropivacaine DRUG

Standard of care 0.5%ropivacaine

Also known as: naropin

ropivacaine only; ropivacaine with dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age-18years and above
• Both male and female patients
• BMI-\>18
• Elective Subacute upper extremity fractures

You may not qualify if:

• Chronic pain patients (Pain persisting for more than 3-6months or past the normal healing time of any injury, influences every aspect of a person's quality of life.)
• Patients with drug abuse history in the past 6 months
• ESRD
• Hepatic failure

Sponsors & Collaborators

• University of Florida: lead

MeSH Terms

Conditions

Agnosia; Acute Pain

Interventions

Dexmedetomidine; Ropivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Alberto Ardon, MD

  University of Florida College of Medicine Jacksonville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized, double blind study of adding dexmedetomidine 0.25mcg/kg body weight to standard dose (25ml) of 0.5%ropivacaine for Brachial plexus block and assessing the analgesia with VAS pain scales (0-10), Satisfaction scale by VAS scale (0-10) and time to first analgesic consumption.

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: December 29, 2017
• Study Start: April 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share