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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00905580
• Other study ID #: IRB 4-2009-0070
• Status: Completed
• Phase: Phase 4
• First received: May 18, 2009
• Last updated: January 15, 2010
• Start date: May 2009
• Est. completion date: September 2009

Study information

• Verified date: October 2009
• Source: Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Pregabalin
Pregabalin 150 mg orally
• Vitamin Complex (placebo)
Vitamin Complex 150 mg orally

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively.		1, 6, 24 & 48 hours	No
Primary	The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.		1, 6, 24 & 48 hours	Yes
Primary	Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively		1, 6, 24 & 48 hours	No
Secondary	Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation.		3 months	No