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Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy

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ClinicalTrials.gov Identifier: NCT00905580
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : January 11, 2010
Last Update Posted : January 20, 2010
Sponsor:
Information provided by:
Severance Hospital

Brief Summary:
The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following robot-assisted endoscopic thyroidectomy 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 3 months after operation.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Pregabalin Drug: Vitamin Complex (placebo) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy
Study Start Date : May 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Placebo Comparator: Placebo
Patients receive oral Placebo 150 mg 1 hour prior to surgery, and 12 hours later
Drug: Vitamin Complex (placebo)
Vitamin Complex 150 mg orally

Experimental: Pregabalin
Patients receive oral pregabalin 150 mg 1 hour prior to surgery, and 12 hours later
Drug: Pregabalin
Pregabalin 150 mg orally




Primary Outcome Measures :
  1. Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively. [ Time Frame: 1, 6, 24 & 48 hours ]
  2. The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. [ Time Frame: 1, 6, 24 & 48 hours ]
  3. Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively [ Time Frame: 1, 6, 24 & 48 hours ]

Secondary Outcome Measures :
  1. Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation. [ Time Frame: 3 months ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. American Society of Anesthesia physical status class I & II
  2. Age ≥ 20 and ≤ 65 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)

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): NCT00905580


Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Severance Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Severance Hospital, Anesthesia and Pain Research Institute
ClinicalTrials.gov Identifier: NCT00905580     History of Changes
Other Study ID Numbers: IRB 4-2009-0070
First Posted: May 20, 2009    Key Record Dates
Results First Posted: January 11, 2010
Last Update Posted: January 20, 2010
Last Verified: October 2009

Keywords provided by Severance Hospital:
thyroidectomy
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