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The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following robot-assisted endoscopic thyroidectomy 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 the incidence of chronic pain and hypoesthesia in the anterior chest at 3 months after operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients receive oral Placebo 150 mg 1 hour prior to surgery, and 12 hours later |
|
| Pregabalin | Experimental | Patients receive oral pregabalin 150 mg 1 hour prior to surgery, and 12 hours later |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Pregabalin 150 mg orally |
| |
| Vitamin Complex (placebo) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively. | 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 means no pain at all, and 10 represents the worst pain imaginable | 1, 6, 24 & 48 hours |
| The 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. We asked patients about sedation, headache, dizziness, blurred vision. | 1, 6, 24 & 48 hours |
| Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively | 1, 6, 24 & 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation. | we checked Hypoesthesia in the anterior chest at 3 months after operation by phone. | 3 months |
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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 and Pain Research Institute, Yonsei University College of Medicine | Seoul | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20376496 | Derived | Kim SY, Jeong JJ, Chung WY, Kim HJ, Nam KH, Shim YH. Perioperative administration of pregabalin for pain after robot-assisted endoscopic thyroidectomy: a randomized clinical trial. Surg Endosc. 2010 Nov;24(11):2776-81. doi: 10.1007/s00464-010-1045-7. Epub 2010 Apr 8. |
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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 (VNRS) at 1, 6, 24, 48 Hours Postoperatively. | 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 means no pain at all, and 10 represents the worst pain imaginable | Posted | Median | Inter-Quartile Range | VNRS | 1, 6, 24 & 48 hours |
|
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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 |
|---|---|---|---|---|---|
| Sedation | General disorders | Systematic Assessment |
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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 150 mg 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 | The 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. We asked patients about sedation, headache, dizziness, blurred vision. | Posted | Number | participants | 1, 6, 24 & 48 hours |
|
|
|
| Secondary | Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation. | we checked Hypoesthesia in the anterior chest at 3 months after operation by phone. | Posted | Number | participants | 3 months |
|
|
|
| Primary | Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively | Posted | Number | participants | 1, 6, 24 & 48 hours |
|
|
|
| 0 |
| 47 |
| 6 |
| 47 |
| EG001 | Pregabalin | Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later | 0 | 47 | 21 | 47 |
| Dizziness | General disorders | Systematic Assessment |
|
| Blurred vision | General disorders | Systematic Assessment |
|
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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 |
| dizziness |
|
| sedation |
|
| blurred vision |
|
| 6 - 24 hour |
|
| 24 - 48 hour |
|