Perioperative Administration of Pregabalin for Pain After Mastectomy

Pain, Postoperative Clinical Trial

Official title:

Perioperative Administration of Pregabalin for Pain After Mastectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00938548
• Other study ID #: IRB 4-2009-0186
• Status: Completed
• Phase: Phase 4
• First received: July 13, 2009
• Last updated: May 17, 2010
• Start date: June 2009
• Est. completion date: January 2010

Study information

• Verified date: July 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 69 Years

Eligibility

Inclusion Criteria:

1. American Society of Anesthesia physical status class I & II

2. Age > 20 and < 70 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 75 mg orally
• Vitamin Complex (placebo)
Vitamin Complex orally

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine and Anesthesia	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 (Verbal Numerical Rating Scale;VNRS) During Postoperative 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 represents no pain at all and 10 represents the worst pain imaginable.	1, 6, 24, 48 hour	No
Primary	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.	1, 6, 24, 48 hour	Yes
Secondary	Pain Scores (VNRS) at 1 Week and 1 Month After Operation	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.	1 week, 1 month	No