Duration of Analgesia With Dexmedetomidine and Ropivacaine in Brachial Plexus Block

NCT ID: NCT03385967

Last Updated: 2019-05-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2019-12-31

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.

Detailed Description

In our institute ropivacaine is used for all the peripheral nerve blocks. This a prospective, randomized, double blind clinical trial study comparing the addition of dexmedetomidine vs ropivacaine alone in brachial plexus nerve block. After screening the patient with the inclusion criteria, an informed consent is obtained from the patient by one of the co-investigator.

Adjuvants to local anesthetics are commonly added to prolong the duration of the peripheral nerve block. Sometimes patients have other added comorbidities along with high BMI with history of chronic pain where prolonging the duration of the peripheral nerve block would help with decreased narcotic consumption in the perioperative period with minimal side effects related to the local anesthetics(LA) as well as the adjuncts.

Dexmedetomidine is proven to be better than Clonidine in a recent study. Also perineural dexmedetomidine is proven to be more efficacious compared to intravenous dosing. The investigators are evaluating whether adding dexmedetomidine to standard dose of Ropivacaine helps in prolonging the duration of the peripheral nerve block with minimal side effects.

Conditions

Analgesia; Pain, Acute; Peripheral Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ropivacaine only

0.5% ropivacaine

Group Type: ACTIVE_COMPARATOR

ropivacaine

Intervention Type: DRUG

Standard of care 0.5%ropivacaine

ropivacaine with dexmedetomidine

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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

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

ropivacaine

Intervention Type: DRUG

Standard of care 0.5%ropivacaine

Interventions

Dexmedetomidine

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

Intervention Type: DRUG

ropivacaine

Standard of care 0.5%ropivacaine

Intervention Type: DRUG

Other Intervention Names

precedex; naropin

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alberto Ardon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida College of Medicine Jacksonville

Other Identifiers

IRB201702926

Identifier Type: -

Identifier Source: org_study_id