Duration of Analgesia With Dexmedetomidine and Ropivacaine in Brachial Plexus Block
Primary Purpose
Analgesia, Pain, Acute, Peripheral Nerve Block
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexmedetomidine
ropivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Analgesia focused on measuring upper extremity bone fracture
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ropivacaine only
ropivacaine with dexmedetomidine
Arm Description
0.5% ropivacaine
25ml of 0.5%ropivacaine with 0.25mcg/kg of dexmedetomidine
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Potential Side Effects
To look for the potential side effects of dexmedetomidine like bradycardia and hypotension in the intraoperative and immediate post-operative period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03385967
Brief Title
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
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Why Stopped
PI is leaving the University of Florida
Study Start Date
April 2019 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Pain, Acute, Peripheral Nerve Block
Keywords
upper extremity bone fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantCare Provider
Masking Description
Double Blind
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ropivacaine only
Arm Type
Active Comparator
Arm Description
0.5% ropivacaine
Arm Title
ropivacaine with dexmedetomidine
Arm Type
Active Comparator
Arm Description
25ml of 0.5%ropivacaine with 0.25mcg/kg of dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
precedex
Intervention Description
Addition of Dexmedetomidine in block .25mcg/kg of dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
ropivacaine
Other Intervention Name(s)
naropin
Intervention Description
Standard of care 0.5%ropivacaine
Primary Outcome Measure Information:
Title
Duration of Effect
Description
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.
Time Frame
Immediate pre-op until 36hours post block
Secondary Outcome Measure Information:
Title
Potential Side Effects
Description
To look for the potential side effects of dexmedetomidine like bradycardia and hypotension in the intraoperative and immediate post-operative period.
Time Frame
Immediate pre-op until 36hours post block
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Ardon, MD
Organizational Affiliation
University of Florida College of Medicine Jacksonville
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Duration of Analgesia With Dexmedetomidine and Ropivacaine in Brachial Plexus Block
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