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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01168531

Enrollment

108

Registered

2010-07-23

Start date

2009-12-31

Completion date

2011-03-31

Last updated

2011-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

patients undergoing lumbar spinal surgery

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.

Interventions

DRUGPregabalin

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

DRUGdexamethasone

Dexamethasone 16 mg, intravenous, before induction of anesthesia

DRUGplacebo

vitamin B complex formula

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026