- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02690506
The Effect of Pregabalin on the Spinal Anesthesia
May 17, 2016 updated by: Younghoon Jeon, Kyungpook National University Hospital
The Effect of Pregabalin on the Spinal Anesthesia: Randomized Controlled Placebo Study
Pregabalin, an anticonvulsant is widely used for treatment of neuropathic pain.
Recently, it was reported that premedication of pregabalin before general anesthesia is effective to reduce postoperative pain.
Up to date, there is no study about the effect of premedication of pregabalin on the spinal anesthesia.
Therefore, in this study, investigators investigate the effect of premedication of pregabalin on the spinal anesthesia.
Study Overview
Detailed Description
In this study, investigators investigate the effect of premedication of pregabaline 150 mg on the spinal anesthesia.
Two hours before spinal anesthesia, placebo pill was administered to patients in the group C and pregabalin 150 mg was administered to patients in the group P, respectively.
Time for the onset of blockade, cephalad level of analgesia and duration of analgesia were measured.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
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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Daegu, Korea, Republic of, 700-721
- Kyungpook National University Hospital
-
-
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
19 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients of American Society of Anaesthesiologists Grades I and II
Exclusion Criteria:
- Patients with infection at the puncture site, coagulopathy, having true hypersensitivity to drugs used, diabetes and hypertension, psychiatric and neurological diseases
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Group C
Oral placebo pill was administered 2 hours before anesthesia
|
|
Active Comparator: Group P
Oral pregabalin 150 mg was administered 2 hours before anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of spinal anesthesia
Time Frame: 24 hours after spinal anesthesia
|
Duration of spinal anesthesia was measured 24 after spinal anesthesia
|
24 hours after spinal anesthesia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
February 1, 2016
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
February 19, 2016
First Submitted That Met QC Criteria
February 23, 2016
First Posted (Estimate)
February 24, 2016
Study Record Updates
Last Update Posted (Estimate)
May 18, 2016
Last Update Submitted That Met QC Criteria
May 17, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
Other Study ID Numbers
- 2014-05-027
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.
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