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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01168531
• Other study ID #: 4-2009-0506
• Status: Completed
• Phase: N/A
• First received: July 20, 2010
• Last updated: August 18, 2011
• Start date: December 2009
• Est. completion date: March 2011

Study information

• Verified date: January 2011
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Pain
• Pain

Intervention

Drug:
• Pregabalin
pregabalin: 300 mg/day, po, from operative day until third postoperative day.
• dexamethasone
Dexamethasone 16 mg, intravenous, before induction of anesthesia
• placebo
vitamin B complex formula

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	No