Clinical trial NCT03385967: Duration of Analgesia With Dexmedetomidine and Ropivacaine in Brachial Plexus Block
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Analgesia
Pain, Acute
Peripheral Nerve Block
Keywords: upper extremity bone fracture
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Duration of Effect
timeFrame: Immediate pre-op until 36hours post block
Secondary outcomes:
measure: Potential Side Effects
timeFrame: Immediate pre-op until 36hours post block
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida College of Medicine Jacksonville
name: Alberto Ardon, MD
role: PRINCIPAL_INVESTIGATOR
References: