Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy
Overview
- Phase
- Phase 4
- Intervention
- Vitamin Complex (placebo)
- Conditions
- Pain, Postoperative
- Sponsor
- Severance Hospital
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively.
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •American Society of Anesthesia physical status class I \& II
- •Age ≥ 20 and ≤ 65 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 150 mg 1 hour prior to surgery, and 12 hours later
Intervention: Vitamin Complex (placebo)
Pregabalin
Patients receive oral pregabalin 150 mg 1 hour prior to surgery, and 12 hours later
Intervention: Pregabalin
Outcomes
Primary Outcomes
Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively.
Time Frame: 1, 6, 24 & 48 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 means no pain at all, and 10 represents the worst pain imaginable
The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.
Time Frame: 1, 6, 24 & 48 hours
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.
Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively
Time Frame: 1, 6, 24 & 48 hours
Secondary Outcomes
- Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation.(3 months)