The Effect of Pregabalin and Dexamethasone on Acute and Chronic Pain After Lumbar Spinal Surgery
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.
|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|
- 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:||December 2009|
|Study Completion Date:||March 2011|
|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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168531
|Korea, Republic of|
|Seoul, Korea, Republic of, 120-752|