Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01168531
First received: July 20, 2010
Last updated: August 18, 2011
Last verified: January 2011
History of Changes
  Purpose

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 Intervention
Pain
 Drug: Pregabalin
Drug: dexamethasone
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of Pregabalin and Dexamethasone on Acute and Chronic Pain After Lumbar Spinal Surgery

Resource links provided by NLM:

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

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 108
Study Start Date: December 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168531

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

No publications provided

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
Study First Received: July 20, 2010
Last Updated: August 18, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
patients undergoing lumbar spinal surgery

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Pregabalin
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
 Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 16, 2013