Intervertebral Disk DisplacementPhase 4NCT00353704
Analgetic and Anxiolytic Effect of Preoperative Pregabalin
A Phase 4 study testing pregabalin and morphine in people with Intervertebral Disk Displacement and Disk Prolapse, run by Asker & Baerum Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intervertebral Disk Displacement, Disk Prolapse
- What is being tested?
- pregabalin and morphine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2005to Jun 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of disc prolapse
- Age 18+
- ASA (American Association in Anesthesiology) I-III
- written consent
Who cannot join
- Age < 18
- ASA > III
- liver failure
- renal failure
- allergic reaction against gabapentin and/or pregabalin
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgetic and Anxiolytic Effect of Preoperative Pregabalin in Patients Undergoing Surgery of the Vertebral Columna
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.
Read the 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.
- Conditions
- Intervertebral Disk Displacement, Disk Prolapse
- Being tested
- pregabalin, Placebo, morphine
- Keywords
- Intervertebral disk displacement, disk prolapse, pregabalin
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Active comparator | 150 mg Pregabalin per orally about one hour before surgery Receives: Drug: pregabalin; Drug: morphine |
| Placebo | Placebo comparator | One capsule of saccharose (placebo) was administered orally about one hour before surgery. Receives: Drug: Placebo; Drug: morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 minutes after surgery
Secondary outcomes (1)
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)
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2006 (estimated)
- Study startNov 2005
- Primary completionMay 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intervertebral Disk DisplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asker & Baerum Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ulrich J Spreng, Dr. med., Principal investigator, Asker and Baerum Hospital, NorwayVegard Dahl, Dr. med., Study director, Asker and Baerum Hospital, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353704
- Sponsor's protocol ID
- 2005-003229-20
- Other IDs
- 2005
- Status last verified
- Jul 2011
- First submitted
- 17 Jul 2006
- Last updated
- 20 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Woolf CJ, Chong MS. Preemptive analgesia--treating postoperative pain by preventing the establishment of central sensitization. Anesth Analg. 1993 Aug;77(2):362-79. doi: 10.1213/00000539-199377020-00026. No abstract available.
PubMed 8346839Menigaux C, Adam F, Guignard B, Sessler DI, Chauvin M. Preoperative gabapentin decreases anxiety and improves early functional recovery from knee surgery. Anesth Analg. 2005 May;100(5):1394-1399. doi: 10.1213/01.ANE.0000152010.74739.B8.
PubMed 15845693Dirks J, Fredensborg BB, Christensen D, Fomsgaard JS, Flyger H, Dahl JB. A randomized study of the effects of single-dose gabapentin versus placebo on postoperative pain and morphine consumption after mastectomy. Anesthesiology. 2002 Sep;97(3):560-4. doi: 10.1097/00000542-200209000-00007.
PubMed 12218520Spreng UJ, Dahl V, Raeder J. Effect of a single dose of pregabalin on post-operative pain and pre-operative anxiety in patients undergoing discectomy. Acta Anaesthesiol Scand. 2011 May;55(5):571-6. doi: 10.1111/j.1399-6576.2011.02410.x. Epub 2011 Mar 8.
PubMed 21385158
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgetic and Anxiolytic Effect of Preoperative Pregabalin in Patients Undergoing Surgery of the Vertebral Columna
- ClinicalTrials.gov ID
- NCT00353704
- Acronym / sponsor ID
- 2005-003229-20
- Conditions
- Intervertebral Disk Displacement, Disk Prolapse
- Keywords
- Intervertebral disk displacement, disk prolapse, pregabalin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Asker & Baerum HospitalUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 19 Jul 2006 (estimated)
- Results
- Posted 20 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Active comparator | Drug: pregabalin, Drug: morphine150 mg Pregabalin per orally about one hour before surgery |
| Placebo | Placebo comparator | Drug: Placebo, Drug: morphineOne capsule of saccharose (placebo) was administered orally about one hour before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of disc prolapse
- Age 18+
- ASA (American Association in Anesthesiology) I-III
- written consent
Key exclusion criteria (6 listed)
- Age < 18
- ASA > III
- liver failure
- renal failure
- allergic reaction against gabapentin and/or pregabalin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pregabalincapsule 150 mg x 1 per orally one hour before surgery | Drug | Pregabalin |
| PlaceboOne capsule of saccharose (placebo) was administered about one hour before surgery | Drug | Placebo |
| morphineAll patients were equipped with a PCA (patient controlled analgesia) for 24 hours after surgery. The sum of morphine used was registered (milligram). | Drug | Placebo, Pregabalin |
Primary outcome
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.
1 secondary outcome
Morphine (Opioid) Consumption Cumulated
Time frame: 240 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8346839Woolf CJ, Chong MS. Preemptive analgesia--treating postoperative pain by preventing the establishment of central sensitization. Anesth Analg. 1993 Aug;77(2):362-79. doi: 10.1213/00000539-199377020-00026. No abstract available.
- Background: PubMed 15845693Menigaux C, Adam F, Guignard B, Sessler DI, Chauvin M. Preoperative gabapentin decreases anxiety and improves early functional recovery from knee surgery. Anesth Analg. 2005 May;100(5):1394-1399. doi: 10.1213/01.ANE.0000152010.74739.B8.
- Background: PubMed 12218520Dirks J, Fredensborg BB, Christensen D, Fomsgaard JS, Flyger H, Dahl JB. A randomized study of the effects of single-dose gabapentin versus placebo on postoperative pain and morphine consumption after mastectomy. Anesthesiology. 2002 Sep;97(3):560-4. doi: 10.1097/00000542-200209000-00007.
- Derived from this study: PubMed 21385158Spreng UJ, Dahl V, Raeder J. Effect of a single dose of pregabalin on post-operative pain and pre-operative anxiety in patients undergoing discectomy. Acta Anaesthesiol Scand. 2011 May;55(5):571-6. doi: 10.1111/j.1399-6576.2011.02410.x. Epub 2011 Mar 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich J Spreng, Dr. med. principal investigator
Asker and Baerum Hospital, Norway
Vegard Dahl, Dr. med. study director
Asker and Baerum Hospital, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pregabalin and morphine in people with Intervertebral Disk Displacement and Disk Prolapse, run by Asker & Baerum Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm) (time frame: 120 minutes after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00353704, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2011.