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

NCT01168531 | Completed

• 1 other identifier: 4-2009-0506
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

patients undergoing lumbar spinal surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

placebo arm

PLACEBO COMPARATOR

Drug: placebo

pregabalin arm

ACTIVE COMPARATOR

Drug: Pregabalin

dexamethasone with pregabalin arm

EXPERIMENTAL

Drug: dexamethasone

Interventions

Pregabalin DRUG

pregabalin: 300 mg/day, po, from operative day until third postoperative day.

pregabalin arm

dexamethasone DRUG

Dexamethasone 16 mg, intravenous, before induction of anesthesia

dexamethasone with pregabalin arm

placebo DRUG

vitamin B complex formula

placebo arm

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Pain

Interventions

Pregabalin; Dexamethasone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: July 23, 2010
• Study Start: December 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: August 19, 2011

Record last verified: 2011-01

Locations

KR (1)