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OpenTrials
Completed

NCT Number: NCT01168531

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

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.

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Key information

Conditions

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

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pregabalin

Drug

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

Dexamethasone

Drug

Dexamethasone 16 mg, intravenous, before induction of anesthesia

Placebo

Drug

vitamin B complex formula

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 23, 2010
Registry last updated
Aug 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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