Perioperative Administration of Pregabalin for Pain After Mastectomy - Full Text View

Sponsored by:	Severance Hospital
Information provided by:	Severance Hospital
ClinicalTrials.gov Identifier:	NCT00938548

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 the incidence of chronic pain and hypoesthesia in the anterior chest at 1 week, 1 month, 3 months after operation.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Perioperative Administration of Pregabalin for Pain After Mastectomy

Resource links provided by NLM:

MedlinePlus related topics: Ataxia Telangiectasia Mastectomy Nausea and Vomiting Surgery

Drug Information available for: Pregabalin

U.S. FDA Resources

Further study details as provided by Severance Hospital:

Primary Outcome Measures:

Pain scores (VNRS) and analgesic consumption at 1, 6, 24, 48 hours postoperatively. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Side effects - nausea & vomiting (four-point scale), sedation (four-point scale), headache, dizziness etc. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Chronic pain at 1 week, 1 month, 3 months after operation. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Hypoesthesia in the anterior chest at 1 week, 1 month, 3 months after operation. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	June 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later	Drug: Vitamin Complex (placebo) Vitamin Complex orally
Pregabalin: Experimental Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later	Drug: Pregabalin Pregabalin 150 mg orally

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

American Society of Anesthesia physical status class I & II
Age > 18 and < 65 years
Robot- assisted endoscopic thyroidectomy

Exclusion Criteria:

Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications
BMI ≥ 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 DM
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

Contacts

Contact: Yeon Hee Shim, MD, PhD	82-2-2228-2432	tren125@yuhs.ac
Contact: So Yeon Kim	82-2-376-8295	kimsy326@hanmail.net

Locations

Korea, Republic of
Department of Anesthesiology and Pain Medicine and Anesthesia	Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Yeon Hee Shim, MD, PhD 82-2-2228-2432 tren125@yuhs.ac.kr
Principal Investigator: So Yeon Kim, MD

Sponsors and Collaborators

Severance Hospital

More Information

No publications provided

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

Keywords provided by Severance Hospital:

mastectomy
pain, postoperative
pregabalin

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Vitamins
Pregabalin
Trace Elements
Pain

Peripheral Nervous System Agents
Analgesics
Micronutrients
Anticonvulsants
Pain, Postoperative

Additional relevant MeSH terms:

Growth Substances
Physiological Effects of Drugs
Pregabalin
Pain
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Postoperative Complications
Sensory System Agents

Therapeutic Uses
Vitamins
Peripheral Nervous System Agents
Micronutrients
Analgesics
Central Nervous System Agents
Anticonvulsants
Pain, Postoperative

ClinicalTrials.gov processed this record on September 11, 2009