Perioperative Administration of Pregabalin for Pain After Mastectomy

Phase 4

Completed

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

• Registration Number: NCT00938548
• Lead Sponsor: Severance Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Status Verified: 2009-07
• Study First Submitted: 2009-07-13
• Study First Submitted QC: 2009-07-13
• Study First Posted: 2009-07-14
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Results First Submitted: 2010-03-29
• Results First Submitted QC: 2010-04-27
• Results First Posted: 2010-05-14
• Last Update Submitted: 2010-05-17
• Last Update Posted: 2010-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours.	1, 6, 24, 48 hour	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.
Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.	1, 6, 24, 48 hour	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.

Secondary Outcome Measures

Name	Time	Method
Pain Scores (VNRS) at 1 Week and 1 Month After Operation	1 week, 1 month	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.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine and Anesthesia; 🇰🇷 Seoul, Korea, Republic of