Disk Prolapse, Intervertebral Disk Displacement
Conditions
Keywords
Intervertebral disk displacement, disk prolapse, pregabalin
Brief summary
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.
Detailed 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.
Interventions
DRUGpregabalin
capsule 150 mg x 1 per orally one hour before surgery
DRUGPlacebo
One capsule of saccharose (placebo) was administered about one hour before surgery
DRUGmorphine
All patients were equipped with a PCA (patient controlled analgesia) for 24 hours after surgery. The sum of morphine used was registered (milligram).
Sponsors
Asker & Baerum Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm) | 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
| Measure | Time frame | Description |
|---|---|---|
| Morphine (Opioid) Consumption Cumulated | 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) |
Countries
Norway
Participant flow
Recruitment details
recruitment period november 2005 until june 2008
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin | 25 |
| Placebo | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 3 | 1 |
Baseline characteristics
| Characteristic | Placebo | Pregabalin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 50 Participants |
| Age Continuous | 43 years STANDARD_DEVIATION 8 | 44 years STANDARD_DEVIATION 11 | 43 years STANDARD_DEVIATION 10 |
| Region of Enrollment Norway | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 24 |
| serious Total, serious adverse events | 0 / 22 | 0 / 24 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm) | 11.7 Units on a scale | Standard Deviation 9.6 |
| Placebo | Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm) | 22.5 Units on a scale | Standard Deviation 14.4 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Morphine (Opioid) Consumption Cumulated | 7.3 mg | Standard Deviation 6.3 |
| Placebo | Morphine (Opioid) Consumption Cumulated | 16.0 mg | Standard Deviation 13.2 |