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

This study has been completed.
Sponsor:
Information provided by:
Severance Hospital
ClinicalTrials.gov Identifier:
NCT00905580
First received: May 18, 2009
Last updated: January 15, 2010
Last verified: October 2009
  Purpose

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 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 Robot-assisted Endoscopic Thyroidectomy

Resource links provided by NLM:


Further study details as provided by Severance Hospital:

Primary Outcome Measures:
  • Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively. [ Time Frame: 1, 6, 24 & 48 hours ] [ Designated as safety issue: No ]
  • The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. [ Time Frame: 1, 6, 24 & 48 hours ] [ Designated as safety issue: Yes ]
  • Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively [ Time Frame: 1, 6, 24 & 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: May 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  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: NCT00905580     History of Changes
Other Study ID Numbers: IRB 4-2009-0070
Study First Received: May 18, 2009
Results First Received: October 13, 2009
Last Updated: January 15, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Severance Hospital:
thyroidectomy
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
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014