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

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. Identifier: NCT00905580
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : January 11, 2010
Last Update Posted : January 20, 2010
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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT00905580

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 Identifier (NCT Number):
Responsible Party: Severance Hospital, Anesthesia and Pain Research Institute 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:
pain, postoperative

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