Analgetic and Anxiolytic Effect of Preoperative Pregabalin

Asker & Baerum Hospital

Status and phase: Completed; Phase 4

Conditions: Disk Prolapse; Intervertebral Disk Displacement

Treatments: Drug: Placebo; Drug: pregabalin; Drug: morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT00353704

2005-003229-20

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Pregabalin

Active Comparator group

Description:

150 mg Pregabalin per orally about one hour before surgery

Treatment:

Drug: morphine

Drug: pregabalin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: morphine