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

August 18, 2011 updated by: Yonsei University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo arm
Drug: placebo
vitamin B complex formula
Active Comparator: pregabalin arm
Drug: Pregabalin
pregabalin: 300 mg/day, po, from operative day until third postoperative day.
Experimental: dexamethasone with pregabalin arm
Drug: dexamethasone
Dexamethasone 16 mg, intravenous, before induction of anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

July 20, 2010

First Submitted That Met QC Criteria

July 22, 2010

First Posted (Estimate)

July 23, 2010

Study Record Updates

Last Update Posted (Estimate)

August 19, 2011

Last Update Submitted That Met QC Criteria

August 18, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2009-0506

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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