Perioperative Administration of Pregabalin for Pain After Mastectomy
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|ClinicalTrials.gov Identifier: NCT00938548|
Recruitment Status : Completed
First Posted : July 14, 2009
Results First Posted : May 14, 2010
Last Update Posted : May 25, 2010
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Drug: Pregabalin Drug: Vitamin Complex (placebo)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Perioperative Administration of Pregabalin for Pain After Mastectomy|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||January 2010|
Placebo Comparator: Placebo
Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
Drug: Vitamin Complex (placebo)
Vitamin Complex orally
Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
Pregabalin 75 mg orally
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938548
|Korea, Republic of|
|Department of Anesthesiology and Pain Medicine and Anesthesia|
|Seoul, Korea, Republic of, 120-752|