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Perioperative Administration of Pregabalin for Pain After Mastectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00938548
First Posted: July 14, 2009
Last Update Posted: May 25, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Severance Hospital
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Perioperative Administration of Pregabalin for Pain After Mastectomy

Resource links provided by NLM:


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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 69 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: July 13, 2009
First Posted: July 14, 2009
Results First Submitted: March 29, 2010
Results First Posted: May 14, 2010
Last Update Posted: May 25, 2010
Last Verified: July 2009

Keywords provided by Severance Hospital:
mastectomy
pain, postoperative
pregabalin

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Vitamins
Pregabalin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs