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The Effect of Pregabalin and Dexamethasone on Acute and Chronic Pain After Lumbar Spinal Surgery

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.
ClinicalTrials.gov Identifier: NCT01168531
Recruitment Status : Completed
First Posted : July 23, 2010
Last Update Posted : August 19, 2011
Information provided by:

Study Description
Brief Summary:
Multimodal analgesia may be important for optimal postoperative pain treatment and facilitation of early mobilization and recovery. This study investigated the analgesic effect of pregabalin and dexamethasone in patients undergoing lumbar spinal surgery.

Condition or disease Intervention/treatment
Pain Drug: Pregabalin Drug: dexamethasone Drug: placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of Pregabalin and Dexamethasone on Acute and Chronic Pain After Lumbar Spinal Surgery
Study Start Date : December 2009
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: placebo arm Drug: placebo
vitamin B complex formula
Active Comparator: pregabalin arm Drug: Pregabalin
pregabalin: 300 mg/day, po, from operative day until third postoperative day.
Experimental: dexamethasone with pregabalin arm Drug: dexamethasone
Dexamethasone 16 mg, intravenous, before induction of anesthesia

Outcome Measures

Primary Outcome Measures :
  1. the multimodal analgesic effect of pregabalin, and of pregabalin with dexamethasone [ Time Frame: Assessment was performed during the first 72 hour following emergence from general anesthesia, subdivided into 5 time periods; on arrival of patient to the PACU, 1-6 hour, 6-24 hour, 24-48 hour and 48-72 hour ]
    Primary Outcome is to investigate the multimodal analgesic effect of pregabalin, and of pregabalin with dexamethasone, in patients receiving a patient-controlled analgeisa with fentanyl, on fentanyl consumption (primary end point), pain scores and side effects in patients scheduled for lumbar spinal surgery.

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • patients scheduled for lumbar spinal surgery, aged 20 to 70 years, with a body mass index (BMI) from 18 to 32 and an American Society of Anesthesiologists (ASA)physical status classification of I-II were eligible for the study.

Exclusion Criteria:

  • allergy to any drugs in the study
  • alcohol and/or drug abuse
  • treatment with antacids or antidepressants
  • a history of diabetes or epilepsy
  • a daily intake of analgesics or an intake of any analgesic within 24 h before surgery
  • treatment with systemic glucocorticoids within 4 weeks before surgery
  • known impaired hepatic and renal function.
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): NCT01168531

Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
More Information

Responsible Party: Jae Kwang Shim / Assistant Professor, Department of Anesthesiology & Pain Medicine, Severance Hospital
ClinicalTrials.gov Identifier: NCT01168531     History of Changes
Other Study ID Numbers: 4-2009-0506
First Posted: July 23, 2010    Key Record Dates
Last Update Posted: August 19, 2011
Last Verified: January 2011

Keywords provided by Yonsei University:
patients undergoing lumbar spinal surgery

Additional relevant MeSH terms:
Chronic Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Sensory System Agents
Calcium Channel Blockers
Membrane Transport Modulators
Anti-Anxiety Agents
Tranquilizing Agents