Analgetic and Anxiolytic Effect of Preoperative Pregabalin

Asker & Baerum Hospital50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Intervertebral Disk Displacement Disk Prolapse

Interventions

pregabalinDRUG

capsule 150 mg x 1 per orally one hour before surgery

PlaceboDRUG

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

morphineDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Asker and Baerum Hospital

Rud, Norway

Outcomes

Primary Outcomes

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

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.

Time frame: 120 minutes after surgery

Secondary Outcomes

Morphine (Opioid) Consumption Cumulated

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)

Time frame: 240 minutes

Data from ClinicalTrials.gov

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