Back to resultsThe Effect of Pregabalin and Dexamethasone on Acute and Chronic Pain After Lumbar Spinal Surgery
Primary Purpose
Pain
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pregabalin
dexamethasone
placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Pain focused on measuring patients undergoing lumbar spinal surgery
Eligibility 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.
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Experimental
Arm Label
placebo arm
pregabalin arm
dexamethasone with pregabalin arm
Arm Description
Outcomes
Primary Outcome Measures
the multimodal analgesic effect of pregabalin, and of pregabalin with dexamethasone
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01168531
Brief Title
The Effect of Pregabalin and Dexamethasone on Acute and Chronic Pain After Lumbar Spinal Surgery
Official Title
The Effect of Pregabalin and Dexamethasone on Acute and Chronic Pain After Lumbar Spinal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
patients undergoing lumbar spinal surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo arm
Arm Type
Placebo Comparator
Arm Title
pregabalin arm
Arm Type
Active Comparator
Arm Title
dexamethasone with pregabalin arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
pregabalin: 300 mg/day, po, from operative day until third postoperative day.
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
Dexamethasone 16 mg, intravenous, before induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
vitamin B complex formula
Primary Outcome Measure Information:
Title
the multimodal analgesic effect of pregabalin, and of pregabalin with dexamethasone
Description
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.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
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The Effect of Pregabalin and Dexamethasone on Acute and Chronic Pain After Lumbar Spinal Surgery
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