Duration of Analgesia With Dexmedetomidine and Ropivacaine in Brachial Plexus Block

Phase 4

Withdrawn

• Conditions: Analgesia; Peripheral Nerve Block; Pain, Acute
• Interventions: Drug: ropivacaine; Drug: Dexmedetomidine

• Registration Number: NCT03385967
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-27
• Study First Posted: 2017-12-29
• Study Start: 2019-04
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-23
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ropivacaine only	ropivacaine	0.5% ropivacaine
ropivacaine with dexmedetomidine	Dexmedetomidine	25ml of 0.5%ropivacaine with 0.25mcg/kg of dexmedetomidine
ropivacaine with dexmedetomidine	ropivacaine	25ml of 0.5%ropivacaine with 0.25mcg/kg of dexmedetomidine

Primary Outcome Measures

Name	Time	Method
Duration of Effect	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

Name	Time	Method
Potential Side Effects	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.