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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later |
|
| Pregabalin | Experimental | Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Pregabalin 75 mg orally |
| |
| Vitamin Complex (placebo) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. | 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, 6, 24, 48 hour |
| Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | 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. | 1, 6, 24, 48 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores (VNRS) at 1 Week and 1 Month After Operation | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine and Anesthesia | Seoul | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21288209 | Derived | Kim SY, Song JW, Park B, Park S, An YJ, Shim YH. Pregabalin reduces post-operative pain after mastectomy: a double-blind, randomized, placebo-controlled study. Acta Anaesthesiol Scand. 2011 Mar;55(3):290-6. doi: 10.1111/j.1399-6576.2010.02374.x. |
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Of a total of 78 patients assessed for eligibility, 70 subjects received pregabalin or placebo after randomization.
Eight patients were excluded because some patients refused to participate and some patients have psychiatric disorder and insulin-dependent DM.
This study was approved by the Institutional Ethics Committee of Yonsei University Medical Center.
Datas were collected between June and December 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later |
| FG001 | Pregabalin | Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later |
| BG001 | Pregabalin | Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. | 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. | Posted | Median | Full Range | Units on a scale | 1, 6, 24, 48 hour |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. So Yeon Kim | Department of Anaesthesiology and Pain Medicine and Anaesthesia and Pain Research Institute, Department of surgery, Yonsei University College of Medicine | 82-2-2227-3642 | kimsy326@hanmail.net |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Drug |
Vitamin Complex orally |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | 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. | Posted | Number | participants | 1, 6, 24, 48 hour |
|
|
|
| Secondary | Pain Scores (VNRS) at 1 Week and 1 Month After Operation | 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. | Posted | Mean | Standard Deviation | Units on a scale | 1 week, 1 month |
|
|
|
| 0 |
| 35 |
| 18 |
| 35 |
| EG001 | Pregabalin | Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later | 0 | 35 | 19 | 35 |
| sedation | Nervous system disorders |
|
| headache | Nervous system disorders |
|
| PONV | Gastrointestinal disorders |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| headache |
|
| dizziness |
|