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

Yonsei University108 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

108

Conditions

Pain

Interventions

PregabalinDRUG

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

dexamethasoneDRUG

Dexamethasone 16 mg, intravenous, before induction of anesthesia

placeboDRUG

vitamin B complex formula

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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.

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

Data from ClinicalTrials.gov

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