- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02544893
Postoperative Analgesic Effects of Using Dexmedetomidine for Ultrasound Guided Thoracic Paravertebral Block
August 2, 2016 updated by: Esra Nur Ünalan, TC Erciyes University
Postoperative Analgesic Effects of Using Bupivacaine Alone or Added Dexmedetomidine for Ultrasound Guided Thoracic Paravertebral Block in Thoracotomy
we aimed postoperative analgesic effects of using bupivacaine alone or added dexmedetomidine for ultrasound guided thoracic paravertebral block in thoracotomy
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
paravertebral block is commonly used in the treatment for acute and chronic pain.The duration of paravertebral block could theoretically be prolonged with neurolytic agents.
Dexmedetomidine ,an alfa-2 adrenoreceptor agonist, is being used and adjuvant capable of prolonging duration of sensory and motor block on nerve blocks.
Study Type
Interventional
Enrollment (Actual)
93
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Kayseri, Turkey, 38080
- Erciyes university medicine faculty
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA 1-2
- 18-65 aged
- patient undergoing thoracotomy
Exclusion Criteria:
- chronic opioid consumption
- bupivacaine and dexmedetomidine allergies
- coagulopathy
- infection at the needle insertion side
- chronic liver and kidney disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: bupivacaine
0,5% 20 ml bupivacaine added 0.9% 1 ml serum physiologic on paravertebral block
|
21 ml 0.5 %bupivacaine is applied paravertebral space
Other Names:
|
|
Active Comparator: dexmedetomidine
100 mcg dexmedetomidine added to 0,5% 20 ml bupivacaine on paravertebral block
|
1 ml dexmedetomidin + 20 ml 0.5 % bupivacaine are applied paravertebral space
Other Names:
|
|
Active Comparator: serum phsyologic
0,9% 21 ml serum physiologic
|
21 ml serum physiologic is applied paravertebral space
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
opioid consumption
Time Frame: postoperative 24 hours
|
patient controlled analgesia
|
postoperative 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visual analog scale
Time Frame: postoperative 1 day
|
visual analog scale
|
postoperative 1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: esra n ünalan, resident, TC Erciyes University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
September 7, 2015
First Submitted That Met QC Criteria
September 7, 2015
First Posted (Estimate)
September 9, 2015
Study Record Updates
Last Update Posted (Estimate)
August 3, 2016
Last Update Submitted That Met QC Criteria
August 2, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Anesthetics, Local
- Dexmedetomidine
- Bupivacaine
Other Study ID Numbers
- 2014/649
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.