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

NCT ID: NCT01168531

Last Updated: 2011-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-03-31

Brief Summary

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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

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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placebo arm

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

vitamin B complex formula

pregabalin arm

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type DRUG

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

dexamethasone with pregabalin arm

Group Type EXPERIMENTAL

dexamethasone

Intervention Type DRUG

Dexamethasone 16 mg, intravenous, before induction of anesthesia

Interventions

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Pregabalin

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

Intervention Type DRUG

dexamethasone

Dexamethasone 16 mg, intravenous, before induction of anesthesia

Intervention Type DRUG

placebo

vitamin B complex formula

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Department of Anesthesiology & Pain Medicine, Severance Hospital

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2009-0506

Identifier Type: -

Identifier Source: org_study_id

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