Perioperative Administration of Pregabalin for Pain After Mastectomy

Study Overview
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Brief Summary
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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.

Official Title
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Perioperative Administration of Pregabalin for Pain After Mastectomy

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Pregabalin
* Drug: Vitamin Complex (placebo)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later | Drug: Vitamin Complex (placebo)<br>* Vitamin Complex orally<br>|
| Experimental: Pregabalin<br>Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later | Drug: Pregabalin<br>* Pregabalin 75 mg orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mastectomy, pain, postoperative, pregabalin