- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00938548
Perioperative Administration of Pregabalin for Pain After Mastectomy
May 17, 2010 updated by: Severance Hospital
The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following total mastectomy compared to placebo.
The primary outcome will be acute postoperative pain, measured by a verbal numerical rating score (VNRS) and total analgesic consumption during postoperative 48 hours.
The secondary outcome will be VNRS at 1 week and 1 month after operation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
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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Seoul, Korea, Republic of, 120-752
- Department of Anesthesiology and Pain Medicine and Anesthesia
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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
21 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- American Society of Anesthesia physical status class I & II
- Age > 20 and < 70 years
- Robot- assisted endoscopic thyroidectomy
Exclusion Criteria:
- Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications
- Body mass index ≥ 40 kg/m2
- History of seizure disorder
- Current therapy with pregabalin, gabapentin, or any opioid
- Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection
- Insulin-dependent diabetes mellitus
- Renal insufficiency (estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2)
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: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
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Vitamin Complex orally
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Experimental: Pregabalin
Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
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Pregabalin 75 mg orally
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours.
Time Frame: 1, 6, 24, 48 hour
|
Pain was evaluated using an 11-point verbal numerical rating scale (VNRS).
Patients were instructed preoperatively to express their pain on the 0-10 VNRS, where 0 represents no pain at all and 10 represents the worst pain imaginable.
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1, 6, 24, 48 hour
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Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.
Time Frame: 1, 6, 24, 48 hour
|
Nausea and vomiting was graded on a four-point scale, where 0 = no nausea, 1 = mild nausea, 2 = severe nausea requiring antiemetics, and 3 = retching and/ or vomiting.
Grades 3 and 4 were grouped together as postoperative nausea and vomiting (PONV) and rescue anti-emetic, metoclopramide 10 mg i.v. was given.
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1, 6, 24, 48 hour
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Scores (VNRS) at 1 Week and 1 Month After Operation
Time Frame: 1 week, 1 month
|
Pain was evaluated using an 11-point verbal numerical rating scale (VNRS).
Patients were instructed preoperatively to express their pain on the 0-10 VNRS, where 0 represents no pain at all and 10 represents the worst pain imaginable.
|
1 week, 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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
June 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
July 13, 2009
First Submitted That Met QC Criteria
July 13, 2009
First Posted (Estimate)
July 14, 2009
Study Record Updates
Last Update Posted (Estimate)
May 25, 2010
Last Update Submitted That Met QC Criteria
May 17, 2010
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- 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
- IRB 4-2009-0186
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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