Postoperative PainPhase 4NCT01507363
Analgesic Effect of Gabapentin in Total Knee Arthroplasty (TKA)
A Phase 4 study testing Gabapentin in people with Postoperative Pain and Postoperative Sedation, run by Hvidovre University Hospital at 3 sites in Denmark.
Trial summary
Pain is a major problem after TKA. Gabapentin may reduce acute postoperative pain. The investigators therefore investigate the effect of Gabapentin as a perioperative analgesic. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Postoperative Pain, Postoperative Sedation
- What is being tested?
- Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 3 sitesDenmark
- Study dates
- Jan 2012to Nov 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary, unilateral total knee arthroplasty (TKA)
- Age 50-85 years
- Ethnic Danes
Who cannot join
- Treatment with gabapentins, systemic glucocorticoids, opioids, anxiolytic agents, antiepileptics or antidepressive agents (last 4 weeks)
- History of depression or mania
- History of alcohol or drug abuse
- History of malignancy
- History of epilepsia
- BMI > 40
Show all 11Show fewer
- Disease affecting central or peripheral nerve function
- History of dementia
- History of renal insufficiency
- Allergy to Gabapentin
- Women with menstruation (last 2 years)
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Dep. of ortopedic surgery, Aalborg Sygehus
Aalborg, Aalborg, 9000
Dep. of anesthesiology and ortopedic surgery Hvidovre Hospital
Copenhagen, Hvidovre
Dep. of ortopedic surgery, Esbjerg Sygehus
Esbjerg, Esbjerg, 6700
About this study
Official title: Analgesic Effect of Perioperative Gabapentin in Total Knee Arthroplasty: A Randomized, Double-blind, Placebo-controlled, Dose-response Study
Pain is a major problem after TKA. Gabapentin may reduce acute postoperative pain. The investigators therefore investigate the effect of Gabapentin as a perioperative analgesic.
Read the detailed description
Pain is a major problem after TKA. Studies indicate that Gabapentin may reduce acute postoperative pain. However, the optimal dose is unknown and there is constant controversy on analgesic versus side-effects. The investigators therefore investigate the effect of Gabapentin as a perioperative analgesic in a dose-related manner and with a sample-size allowing evaluation of side-effects.
- Conditions
- Postoperative Pain, Postoperative Sedation
- Being tested
- Gabapentin, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Tables with Gabapentin (1300 mg/ day) for 7 days, starting on the day of surgery
GabapentinDrug
Tables with Gabapentin (900 mg/day) for 7 days, starting on the day of surgery
PlaceboDrug
Placebo tablets for 7 days, starting on the day of surgery
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin "high" | Active comparator | Tables with Gabapentin (1300 mg/day) for 7 days, starting on the day of surgery Receives: Drug: Gabapentin |
| Gabapentin "intermediate" | Active comparator | Tables with Gabapentin for 7 days (900 mg/day), starting on the day of surgery Receives: Drug: Gabapentin |
| Placebo | Placebo comparator | Placebo tablets for 7 days, starting on the day of surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain during walking at 24 hour after surgery, visuel analog scale (VAS, 0-100 mm)
Measured: At 24 hour
Secondary outcomes (9)
Sedation
Sedation at 6 hours, numeric range scale (NRS, 0-10)
Measured: At 6 hours
Pain
Pain at rest and during walking the first week after TKA, visuel analog scale (VAS, 0-100 mm)
Measured: 1 week
Cumulated pain scores
Cumulated pain scores for pain the first week after TKA
Measured: 1 week
Amount of rescue analgesic
Amount of rescue analgesic the first week after TKA, mg
Measured: 1 week
Side effects
Side effects the first week after TKA
Measured: 1 week
Cumulated side effects scores
Cumulated side effects scores the first week after TKA
Measured: 1 week
Amount of ondansetron and sleeping medicine
Amount of ondansetron and sleeping medicine the first week after TKA, mg
Measured: 1 week
Anxiety and depression
Anxiety and depression - questionnaire - the first week after TKA, Hospitality and Anxiety and Depression Scale
Measured: 1 week
Gabapentin level in blood-sample
Gabapentin level in blood-sample at 12 am on the first day after surgery, serum-koncentration
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation
- Responsible party
- Principal investigator, Troels Haxholdt Lunn, Hvidovre University Hospital
- Investigators
- Torben B Hansen B Hansen, MD, Principal investigator, Regionshospitalet HolstebroHenrik Kehlet, MD, Study director, Copenhagen University Hospital, RigshospitaletJørgen B Dahl, MD, Principal investigator, Copenhagen University Hospital, RigshospitaletPer W Kristensen, MD, Principal investigator, Vejle SygehusHenrik Husted, MD, Principal investigator, Hvidovre University HospitalSøren Solgaard, MD, Principal investigator, Gentofte HospitalMogens B Laursen, MD, Phd., Principal investigator, Aalborg SygehusLars Hansen, MD, Principal investigator, Esbjerg sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507363
- Sponsor's protocol ID
- THL-06-11
- Other IDs
- 2011-003105-22, H-4-2011-082
- Status last verified
- Apr 2014
- First submitted
- 6 Jan 2012
- Last updated
- 11 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Perioperative Gabapentin in Total Knee Arthroplasty: A Randomized, Double-blind, Placebo-controlled, Dose-response Study
- ClinicalTrials.gov ID
- NCT01507363
- Acronym / sponsor ID
- THL-06-11
- Conditions
- Postoperative Pain, Postoperative Sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- Jan 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 10 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain is a major problem after TKA. Gabapentin may reduce acute postoperative pain. The investigators therefore investigate the effect of Gabapentin as a perioperative analgesic.
Detailed description
Pain is a major problem after TKA. Studies indicate that Gabapentin may reduce acute postoperative pain. However, the optimal dose is unknown and there is constant controversy on analgesic versus side-effects. The investigators therefore investigate the effect of Gabapentin as a perioperative analgesic in a dose-related manner and with a sample-size allowing evaluation of side-effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gabapentin "high" | Active comparator | Drug: GabapentinTables with Gabapentin (1300 mg/day) for 7 days, starting on the day of surgery |
| Gabapentin "intermediate" | Active comparator | Drug: GabapentinTables with Gabapentin for 7 days (900 mg/day), starting on the day of surgery |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets for 7 days, starting on the day of surgery |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary, unilateral total knee arthroplasty (TKA)
- Age 50-85 years
- Ethnic Danes
Key exclusion criteria (11 listed)
- Treatment with gabapentins, systemic glucocorticoids, opioids, anxiolytic agents, antiepileptics or antidepressive agents (last 4 weeks)
- History of depression or mania
- History of alcohol or drug abuse
- History of malignancy
- History of epilepsia
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 |
|---|---|---|
| GabapentinTables with Gabapentin (1300 mg/ day) for 7 days, starting on the day of surgery | Drug | Gabapentin "high" |
| GabapentinTables with Gabapentin (900 mg/day) for 7 days, starting on the day of surgery | Drug | Gabapentin "intermediate" |
| PlaceboPlacebo tablets for 7 days, starting on the day of surgery | Drug | Placebo |
Primary outcome
Pain
Time frame: At 24 hour
Pain during walking at 24 hour after surgery, visuel analog scale (VAS, 0-100 mm)
9 secondary outcomes
Sedation
Time frame: At 6 hours
Pain
Time frame: 1 week
Cumulated pain scores
Time frame: 1 week
Amount of rescue analgesic
Time frame: 1 week
Side effects
Time frame: 1 week
Cumulated side effects scores
Time frame: 1 week
Amount of ondansetron and sleeping medicine
Time frame: 1 week
Anxiety and depression
Time frame: 1 week
Gabapentin level in blood-sample
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2014.
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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.
Torben B Hansen B Hansen, MD principal investigator
Regionshospitalet Holstebro
Henrik Kehlet, MD study director
Copenhagen University Hospital, Rigshospitalet
Jørgen B Dahl, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gabapentin in people with Postoperative Pain and Postoperative Sedation, run by Hvidovre University Hospital at 3 sites in Denmark.
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 3 inclusion and 11 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 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain (time frame: At 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2014; AzTrials last refreshed its copy on 8 Nov 2026.