Duration of Analgesia With Dexmedetomidine and Ropivacaine in Brachial Plexus Block

• ClinicalTrials.gov Identifier: NCT03385967
• Recruitment Status: Withdrawn
• First Posted: December 29, 2017
• Last Update Posted: May 23, 2019
• Sponsor: University of Florida
• Information provided by (Responsible Party): University of Florida

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Analgesia; Pain, Acute; Peripheral Nerve Block	Drug: Dexmedetomidine; Drug: ropivacaine	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: Double (Participant, Care Provider)
• Masking Description: Double Blind
• Primary Purpose: Treatment
• Official Title: A Randomized, Prospective, Double Blind Clinical Trial to Investigate the Increase in Duration of Analgesia With Addition of 0.25mcg/kg of Dexmedetomidine (DEX) to 25 ml of 0.5%Ropivacaine in Supraclavicular Brachial Plexus Block.
• Estimated Study Start Date: April 2019
• Estimated Primary Completion Date: December 2019
• Estimated Study Completion Date: December 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: ropivacaine only; 0.5% ropivacaine	Drug: ropivacaine; Standard of care 0.5%ropivacaine; Other Name: naropin
Active Comparator: ropivacaine with dexmedetomidine; 25ml of 0.5%ropivacaine with 0.25mcg/kg of dexmedetomidine	Drug: Dexmedetomidine; Addition of Dexmedetomidine in block .25mcg/kg of dexmedetomidine; Other Name: precedex; Drug: ropivacaine; Standard of care 0.5%ropivacaine; Other Name: naropin

Outcome Measures

Primary Outcome Measures :

1. Duration of Effect [ Time Frame: Immediate pre-op until 36hours post block ]
   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.

Secondary Outcome Measures :

1. Potential Side Effects [ Time Frame: Immediate pre-op until 36hours post block ]
   To look for the potential side effects of dexmedetomidine like bradycardia and hypotension in the intraoperative and immediate post-operative period.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Sponsors and Collaborators

University of Florida

Investigators

• Principal Investigator: Alberto Ardon, MD; University of Florida College of Medicine Jacksonville

More Information

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT03385967
• Other Study ID Numbers: IRB201702926
• First Posted: December 29, 2017
• Last Update Posted: May 23, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by University of Florida:

upper extremity bone fracture

Additional relevant MeSH terms:

Acute Pain; Neurologic Manifestations; Pain; Dexmedetomidine; Ropivacaine; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anesthetics, Local; Anesthetics