The Effect of Pregabalin and Dexamethasone on Acute and Chronic Pain After Lumbar Spinal Surgery
This study has been completed.
Information provided by:
First received: July 20, 2010
Last updated: August 18, 2011
Last verified: January 2011
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Supportive Care
||The Effect of Pregabalin and Dexamethasone on Acute and Chronic Pain After Lumbar Spinal Surgery
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2011 (Final data collection date for primary outcome measure)
Placebo Comparator: placebo arm
vitamin B complex formula
Active Comparator: pregabalin arm
pregabalin: 300 mg/day, po, from operative day until third postoperative day.
Experimental: dexamethasone with pregabalin arm
Dexamethasone 16 mg, intravenous, before induction of anesthesia
|Ages Eligible for Study:
||20 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168531
|Seoul, Korea, Republic of, 120-752 |
No publications provided
||Jae Kwang Shim / Assistant Professor, Department of Anesthesiology & Pain Medicine, Severance Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 20, 2010
||August 18, 2011
||Korea: Food and Drug Administration
Keywords provided by Yonsei University:
patients undergoing lumbar spinal surgery
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 30, 2015
Nervous System Diseases
Signs and Symptoms
Antineoplastic Agents, Hormonal
Calcium Channel Blockers
Central Nervous System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs