Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy

Severance Hospital99 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pain, Postoperative

Interventions

PregabalinDRUG

Pregabalin 150 mg orally

Vitamin Complex (placebo)DRUG

Vitamin Complex 150 mg orally

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. American Society of Anesthesia physical status class I \& II 2. Age ≥ 20 and ≤ 65 years 3. Robot- assisted endoscopic thyroidectomy Exclusion Criteria: 1. Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications 2. Body mass index ≥ 40 kg/m2 3. History of seizure disorder 4. Current therapy with pregabalin, gabapentin, or any opioid 5. Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection 6. Insulin-dependent diabetes mellitus 7. Renal insufficiency (estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2)

Locations (1)

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 1, 6, 24 & 48 hours

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.

we checked Hypoesthesia in the anterior chest at 3 months after operation by phone.

Time frame: 3 months

Data from ClinicalTrials.gov

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