Text Size

Perioperative Administration of Pregabalin for Pain After Mastectomy

This study has been completed.
Sponsor:
Information provided by:
Severance Hospital
ClinicalTrials.gov Identifier:
NCT00938548
First received: July 13, 2009
Last updated: May 17, 2010
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Pain, Postoperative
 Drug: Pregabalin
Drug: Vitamin Complex (placebo)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Perioperative Administration of Pregabalin for Pain After Mastectomy

Resource links provided by NLM:

Drug Information available for: Pregabalin
U.S. FDA Resources

Further study details as provided by Severance Hospital:

Primary Outcome Measures:
  • Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. [ Time Frame: 1, 6, 24, 48 hour ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1, 6, 24, 48 hour ] [ Designated as safety issue: Yes ]
    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:
  • Pain Scores (VNRS) at 1 Week and 1 Month After Operation [ Time Frame: 1 week, 1 month ] [ Designated as safety issue: No ]
    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.


Enrollment: 70
Study Start Date: June 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
 Drug: Vitamin Complex (placebo)
Vitamin Complex orally
Experimental: Pregabalin
Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
 Drug: Pregabalin
Pregabalin 75 mg orally

  Eligibility

Ages Eligible for Study:   21 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00938548

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine and Anesthesia
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Severance Hospital
  More Information

No publications provided by Severance Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Severance Hospital, Anesthesia and Pain Research Institute
ClinicalTrials.gov Identifier: NCT00938548     History of Changes
Other Study ID Numbers: IRB 4-2009-0186
Study First Received: July 13, 2009
Results First Received: March 29, 2010
Last Updated: May 17, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Severance Hospital:
mastectomy
pain, postoperative
pregabalin

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Vitamins
Pregabalin
Micronutrients
Growth Substances
 Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 23, 2013