Perioperative Administration of Pregabalin for Pain After Mastectomy
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Severance Hospital
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours.
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 69 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Placebo
Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
Intervention: Vitamin Complex (placebo) (Drug)
Pregabalin
Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
Intervention: Pregabalin (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Pain Scores (VNRS) at 1 Week and 1 Month After Operation(1 week, 1 month)