Skip to main content
OpenTrials
Completed

NCT Number: NCT00938548

Perioperative Administration of Pregabalin for Pain After Mastectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

21 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology and Pain Medicine and Anesthesia

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesia physical status class I & II
  • Age > 20 and < 70 years
  • Robot- assisted endoscopic thyroidectomy

Exclusion criteria

  • Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications
  • Body mass index ≥ 40 kg/m2
  • History of seizure disorder
  • Current therapy with pregabalin, gabapentin, or any opioid
  • Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection
  • Insulin-dependent diabetes mellitus
  • Renal insufficiency (estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2)

Treatment and study plan

Pregabalin

Drug

Pregabalin 75 mg orally

Vitamin Complex (placebo)

Drug

Vitamin Complex orally

Primary outcomes

  1. Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours.

    Time frame: 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.

  2. Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.

    Time frame: 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 outcomes

  1. Pain Scores (VNRS) at 1 Week and 1 Month After Operation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Severance Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jul 14, 2009
Registry last updated
May 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.