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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: placebo; Drug: Pregabalin; Drug: dexamethasone

• Registration Number: NCT01168531
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-07-20
• Study First Submitted QC: 2010-07-22
• Study First Posted: 2010-07-23
• Status Verified: 2011-01
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Last Update Submitted: 2011-08-18
• Last Update Posted: 2011-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
placebo arm	placebo	-
pregabalin arm	Pregabalin	-
dexamethasone with pregabalin arm	dexamethasone	-

Primary Outcome Measures

Name	Time	Method
the multimodal analgesic effect of pregabalin, and of pregabalin with dexamethasone	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.

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of