Postoperative PainPhase 4NCT01430520
Analgesic Effect of Escitalopram in Total Knee Arthroplasty (TKA)
A Phase 4 study testing Escitalopram in people with Postoperative Pain, run by Hvidovre University Hospital at 3 sites in Denmark.
Trial summary
Pain is a major problem after TKA, especially in patients with high pain catastrophizing. Newer MR-scan studies indicate that Escitalopram may have an immediate cognitive and emotional effect. The investigators therefore investigate the effect of Escitalopram as a perioperative analgesic. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesDenmark
- Study dates
- Sep 2011to May 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary, unilateral total knee arthroplasty (TKA)
- Age > 18 > 81
- Ethnic Danes
- Score > 20 on Pain Catastrophising Scale
Who cannot join
- Medication that causes risk in combination with SSRI (6 month)
- Treatment for anxiety or depression
- History of depression or mania
- Treatment with systemic glucocorticoids (6 month)
- Treatment with opioids (4 weeks)
- Alcohol or drug abuse
Show all 16Show fewer
- History of malignancy
- Fertile woman
- History of epilepsia
- Treatment with anticoagulants
- BMI > 40
- Disease affecting central or peripheral nerve function
- Dementia
- History of gastrointestinal bleeding
- History of hepato- or renal insufficiency
- Allergy to Escitalopram
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Gentofte Hospital
Gentofte Municipality, Hellerup, 2900
Regionshospitalet Holstebro
Holstebro, Holstebro, 7500
Vejle Sygehus
Vejle, Vejle, 7100
About this study
Official title: Analgesic Effect of Perioperative Escitalopram for Patients With High Preoperative Level of Pain Catastrophising in Total Knee Arthroplasty
Pain is a major problem after TKA, especially in patients with high pain catastrophizing. Newer MR-scan studies indicate that Escitalopram may have an immediate cognitive and emotional effect. The investigators therefore investigate the effect of Escitalopram as a perioperative analgesic.
Read the detailed description
Pain is a major problem after TKA, especially in patients with high pain catastrophizing. Newer MR-scan studies indicate that Escitalopram may have an immediate cognitive and emotional effect. Patients with high pain catastrophizing are mentally vulnerable and may be sensitive to the effects of Escitalopram.
We therefore investigate the effect of Escitalopram as a perioperative analgesic in this group of patients where the pain problem is pronounced.
- Conditions
- Postoperative Pain
- Being tested
- Escitalopram, 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.
EscitalopramDrug
Also called Cipralex
Tables with Escitalopram (10 mg), 1 tablet a day for 7 days, starting on the day of surgery
PlaceboDrug
Placebo tablets, 1 tablet a day for 7 days, starting on the day of surgery
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Active comparator | Not described Receives: Drug: Escitalopram |
| Placebo | Placebo comparator | Not described 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
Measured: At 24 hour
Secondary outcomes (6)
Pain
Pain at rest and during walking the first week after TKA
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
Measured: 1 week
Side effects
Side effects the first week after TKA
Measured: 1 week
anxiety, depression, and sleep quality
Anxiety, depression, and sleep quality - questionnaire - the first week after TKA
Measured: 1 week
Escitalopram level in blood-sample
Escitalopram level in blood-sample 48 hours after surgery
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2013
- Study completionMay 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
- 120 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, MD, Principal investigator, Regionshospitalet HolstebroHenrik Kehlet, MD, Study director, Copenhagen University Hospital, RigshospitaletPer W Kristensen, MD, Principal investigator, Vejle SygehusSøren Solgaard, MD, Principal investigator, Gentofte HospitalVibe G Frøkjær, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430520
- Sponsor's protocol ID
- THL-04-11
- Other IDs
- 2011-002034-38, H-3-2011-055
- Status last verified
- Jun 2013
- First submitted
- 7 Sep 2011
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Perioperative Escitalopram for Patients With High Preoperative Level of Pain Catastrophising in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01430520
- Acronym / sponsor ID
- THL-04-11
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- Sep 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 8 Sep 2011 (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, especially in patients with high pain catastrophizing. Newer MR-scan studies indicate that Escitalopram may have an immediate cognitive and emotional effect. The investigators therefore investigate the effect of Escitalopram as a perioperative analgesic.
Detailed description
Pain is a major problem after TKA, especially in patients with high pain catastrophizing. Newer MR-scan studies indicate that Escitalopram may have an immediate cognitive and emotional effect. Patients with high pain catastrophizing are mentally vulnerable and may be sensitive to the effects of Escitalopram.
We therefore investigate the effect of Escitalopram as a perioperative analgesic in this group of patients where the pain problem is pronounced.
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 |
|---|---|---|
| Escitalopram | Active comparator | Drug: Escitalopram |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary, unilateral total knee arthroplasty (TKA)
- Age > 18 > 81
- Ethnic Danes
- Score > 20 on Pain Catastrophising Scale
Key exclusion criteria (16 listed)
- Medication that causes risk in combination with SSRI (6 month)
- Treatment for anxiety or depression
- History of depression or mania
- Treatment with systemic glucocorticoids (6 month)
- Treatment with opioids (4 weeks)
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 |
|---|---|---|
| EscitalopramAlso: CipralexTables with Escitalopram (10 mg), 1 tablet a day for 7 days, starting on the day of surgery | Drug | Escitalopram |
| PlaceboPlacebo tablets, 1 tablet a day 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
6 secondary outcomes
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
anxiety, depression, and sleep quality
Time frame: 1 week
Escitalopram level in blood-sample
Time frame: 48 hours
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 5 Jun 2013.
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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, MD principal investigator
Regionshospitalet Holstebro
Henrik Kehlet, MD study director
Copenhagen University Hospital, Rigshospitalet
Per W Kristensen, MD principal investigator
Vejle Sygehus
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 Escitalopram in people with Postoperative Pain, 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 4 inclusion and 16 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 5 Jun 2013. 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 5 Jun 2013.