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

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Vitamin Complex (placebo); Drug: Pregabalin

• Registration Number: NCT00905580
• Lead Sponsor: Severance Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-18
• Study First Submitted QC: 2009-05-19
• Study First Posted: 2009-05-20
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2009-10
• Results First Submitted: 2009-10-13
• Results First Submitted QC: 2009-12-07
• Results First Posted: 2010-01-11
• Last Update Submitted: 2010-01-15
• Last Update Posted: 2010-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Vitamin Complex (placebo)	Patients receive oral Placebo 150 mg 1 hour prior to surgery, and 12 hours later
Pregabalin	Pregabalin	Patients receive oral pregabalin 150 mg 1 hour prior to surgery, and 12 hours later

Primary Outcome Measures

Name	Time	Method
Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively.	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.	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	1, 6, 24 & 48 hours

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation.	3 months	we checked Hypoesthesia in the anterior chest at 3 months after operation by phone.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of