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NCT Number: NCT00353704

Analgetic and Anxiolytic Effect of Preoperative Pregabalin

The purpose of this study is to determine whether the use of oral pregabalin 150 mg as premedication reduces the amount and degree of postoperative pain.

Furthermore the purpose of this study is to determine whether the use of oral pregabalin 150 mg as premedication reduces anxiety prior to anaesthesia in these patients.

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Key information

Conditions

Intervertebral Disk Displacement Bone Diseases Disk Prolapse Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asker and Baerum Hospital

Rud, 1309, Norway

About this study

The mechanism of development of postoperative pain is complex. Central and peripheral sensitization are playing an important role and this can lead to postoperative hypersensitization. Several studies have shown, that gabapentin can be effective to reduce sensitization and postoperative pain. Pregabalin (S-aminomethyl-5-methylhexaninacid) is a further development of gabapentin. Pregabalin has a fewer side-effects compared with gabapentin.

The purpose of this study is to compare the analgetic and anxiolytic effect of pregabalin and placebo used as premedication.

The hypothesis is that a single-dose pregabalin (150 mg postoperatively (p.o.)) gives significant better anxiolysis and analgesia than placebo.

The study is including patients undergoing surgery of the vertebral columna.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of disc prolapse
  • Age 18+
  • ASA (American Association in Anesthesiology) I-III
  • written consent

Exclusion criteria

  • Age < 18
  • ASA > III
  • liver failure
  • renal failure
  • allergic reaction against gabapentin and/or pregabalin
  • pregnancy

Treatment and study plan

Pregabalin

Drug

capsule 150 mg x 1 per orally one hour before surgery

Placebo

Drug

One capsule of saccharose (placebo) was administered about one hour before surgery

Morphine

Drug

All patients were equipped with a PCA (patient controlled analgesia) for 24 hours after surgery. The sum of morphine used was registered (milligram).

Primary outcomes

  1. Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm)

    Time frame: 120 minutes after surgery

    The visual analogue scale (VAS) was used for registration of the pain intensity at rest. The score ranges from 0-100, where 0 means no pain and 100 means maximal pain. Higher values represent a worse outcome.

Secondary outcomes

  1. Morphine (Opioid) Consumption Cumulated

    Time frame: 240 minutes

    Patients were equipped with a morphine PCA (patient controlled analgesia) for 24 hours after surgery. So they could administrate morphine intravenously by pressing a button. The sum of morphine was registered as " cumulated opioid consumption (milligram)

Sponsors and collaborators

Lead sponsor

Asker & Baerum Hospital

Other

Registry information

Official study title

Analgetic and Anxiolytic Effect of Preoperative Pregabalin in Patients Undergoing Surgery of the Vertebral Columna

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Jul 19, 2006
Registry last updated
Jul 20, 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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