Post Operative Pain, AcutePhase 4NCT05563155
Repeat Dose Steroid to Prevent Pain Relapse After Total Knee Arthroplasty in Patients With High Pain Response
A Phase 4 study testing Dexamethasone 24 mg in people with Post Operative Pain, Acute, run by Vejle Hospital at 1 site in Denmark.
Trial summary
The aim of the study is to compare the effect of a repeat moderate dose of glucocorticoids postoperatively after preoperative high dose upon postoperative pain after Total Knee Arthroplasty (TKA) in an High Pain Respondes (HPR) population to a standard single high dose systemic preoperative administration in an HPR… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Post Operative Pain, Acute
- What is being tested?
- Dexamethasone 24 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2021to 22 Mar 2024
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40 years.
- Primary unilateral TKA.
- Ability to participate in the study (understand written and spoken Danish language, self-reported pain and satisfaction).
- Signed written informed consent form.
- PCS >20.
- Moderate to severe postoperative pain (VAS >30) in a 5-meter walk test 22-26 hours after end of surgery.
Who cannot join
- Ongoing treatment of systemic glucocorticoids or other immunosuppressant treatment apart from inhaled steroids.
- Insulin-dependent diabetes.
- Pregnancy or breastfeeding.*
- Allergies concerning the study-drug.
- Mental disability that could impair a patient's decision-making capability of giving informed consent and not enabling valid data collection.
- Patients with known diagnoses of schizophrenia, ongoing psychosis, bipolar disease and/or a history of ongoing anti-psychotic treatment.
Show all 9Show fewer
- Patients with modulated pain-reception (experience) based on other diseases or injuries, e.g. spinal cord or brain injury, severe polyneuropathies or neurologic disorders.
- Peripheral nerve block per- or postoperatively.
- Pregnancy: No women with suspected or proven pregnancy are eligible for inclusion. The following will be considered as safe contraception: intrauterine device or hormonal contraception. For women aged between 40-50 years, a urine HCG test for pregnancy will be performed.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Vejle Hospital. Orthopedic Surgery Department. Clinical Research Unit
Vejle, 7100
About this study
Official title: Repeat Dose Steroid to Prevent Pain Relapse After Total Knee Arthroplasty in Patients With High Pain Response - A Randomized Double-blind Placebo-controlled Trial
The aim of the study is to compare the effect of a repeat moderate dose of glucocorticoids postoperatively after preoperative high dose upon postoperative pain after Total Knee Arthroplasty (TKA) in an High Pain Respondes (HPR) population to a standard single high dose systemic preoperative administration in an HPR population.
As a standard procedure, all patients referred to the outpatient clinic due to suspected degenerative knee disease will be asked to fulfill the Pain Catastrophizing Scale (PCS). If TKA is decided, patients with a PCS score above 20 will be treated with intravenously administered Dexamethasone 1 mg/kg as a rounded-up-dose to closest 10 mg according to our guideline for FAST-TRACK TKA.
The repeat-dosing group (RDG) will receive a dose of 24 mg dexamethasone tablets at 9-11 pm on the first postoperative day. The control-group (CG) will receive placebo tablets at 9-11 pm on the first postoperative day.
Read the detailed description
Total hip and knee arthroplasty (THA/TKA) are frequently performed procedures and are expected to increase in numbers along with the growing elderly population the next decade.
Total Knee Arthroplasty (TKA) is suitable for FAST-TRACK surgery, and is often performed as outpatient surgery with no hospital overnight stay.
Challenges in FAST-TRACK surgery include postoperative pain, nausea and vomiting (PONV), complications due to rescue-analgesics and surgical complications.
Pain is a well-known clinical problem, with up to 75% of TKA patients experiencing moderate to severe pain the first day after surgery, and 30-40% still experiencing moderate to severe pain 2 weeks after surgery, potentially delaying ambulation and recovery within the first weeks.
The role of severe acute postoperative pain upon the development of chronic pain is debatable, but important.
Data from our recently finished study in High Pain Responders (HPR), defined as patients with a score above 20 on the Pain Catastrophizing Scale (PCS), receiving preoperative high dose dexamethasone (Nielsen et al.: IN PREPARATION, clinicaltrials.gov ID NCT03763734, EudraCT 2018-002635-23, VEK H-18034778) found a persistent moderate to severe pain in 40 % of patients, at time 48 hours after surgery, corresponding to the time when the physiological effect of our dexamethasone intervention declines.
Moderate to severe pain (Visual analogue scale (VAS >30)) 24 hours postoperatively during a 5-meter walk test was associated with relapse pain at 48 hours.
Other studies have made attempts of investigating the effect of a repeated dose of steroids after TKA and Total Hip Arthroplasty (THA), but all have done so with a postoperative injection of low dose steroids. No previous studies have, to our knowledge, investigated the effects of repeat dosing after a preoperative high dose of steroid, and none focused on patients selected by their postoperative pain response. In spite of many studies and systematic reviews on the subject, the optimal timing and dose for steroid-intervention in TKA in different patient groups is still inadequately understood
The study conduct with a repeat moderate dose of steroids given as an oral tablet at 9-11 pm on the day after TKA surgery in patients receiving preoperative high dose steroids, who have a high postoperative pain response, in a FAST-TRACK perioperative setting. Oral administration of the repeat dose will allow for possible early discharge in future clinical settings.
The hypothesis is that a repeat moderate dose of glucocorticoid will reduce the postoperative pain on postoperative day 2 and cumulated pain day 2-3 after TKA surgery, when compared to single high dose preoperatively.
- Conditions
- Post Operative Pain, Acute
- Being tested
- Dexamethasone 24 mg, Placebo
- Keywords
- Dexamethason, repeat, glucocorticoids, TKA surgery, steroids, High Pain Responders, postoperative pain, repeat dosing, FAST-TRACK
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 24 mgDrug
Also called Dexa-ratiopharm
Dexamethasone 24 mg on day 1 after surgery.
PlaceboDrug
Placebo tablet given on day 1 after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Placebo tablet on day 1 after surgery given as one single dose. | Placebo comparator | Control Group (CG):
Intervention: Postoperative oral placebo tablet on day 1 after surgery given as one single dose. Receives: Drug: Placebo |
| Dexamethasone 24 mg on day 1 after surgery given as one single dose. | Active comparator | Repeat Dose Group (RDG):
Intervention: Postoperative oral dexamethasone 24 mg on day 1 after surgery given as one single dose. Receives: Drug: Dexamethasone 24 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain after 48 hours / day 2 morning, according to VAS-scale
The amount of patients with moderate postoperative pain in a 5 meter walk test day 2 morgning(48 hours) postoperatively after total knee-arthroplasty.
Pain is monitored by the Visual Analog Scale(VAS) 0-100 mm, where 0 is no pain and 100 mm is the worst pain. Moderate pain is considered a VAS >30 mm.
Measured: Day 2 morning
Secondary outcomes (8)
Cumulated pain upon ambulation, according to VAS-scale (0-100mm), in a 5-meter walk test
Pain is monitored by the Visual Analog Scale(VAS) 0-100 mm, where 0 is no pain and 100 mm is the worst pain. Moderate pain is considered a VAS >30 mm
Measured: From day 2-3
Cumulated pain score, according to VAS-scale (0-100mm), at rest, upon ambulation in a 5-meter walk test and at night according to VAS-scale(0-100mm)
Pain is monitored by the Visual Analog Scale(VAS) 0-100 mm, where 0 is no pain and 100 mm is the worst pain. Moderate pain is considered a VAS >30 mm
Measured: From day 2-7
Quality of sleep, lethargy, dizziness, and nausea postoperative registration, according to the VAS-scale(0-100mm)
ain is monitored by the Visual Analog Scale(VAS) 0-100 mm, where 0 is no pain and 100 mm is the worst pain. Moderate pain is considered a VAS >30 mm
Measured: From day 2-7
Cumulative use of rescue analgesics per day.
Measured: From day 2-7
Patient satisfaction with analgesic regimen in a ordinal scale from 0 to 10
Measured: Day 7
Number of re-admissions within 30 days, and reasons why (follow-up by EPJ on postoperative day 30)
Measured: Day 30
Morbidity and mortality (30-day follow-up by EPJ or telephone).
Number of participant with morbidity and mortality in the first 30 days. Follow-up by EPJ or telephone.
Measured: Day 30
Why still in hospital, an audit into the reasons the patient has not yet been discharged from the ward
An investigation into reason of why our patients remain in the hospital in the days after total Knee Arthroplasty in our Fast-Track center. This is investigated through a questionnaire previously used in a similar investigation in our center.
The questionnaire is filled in by our project nurse. the questionnaire is a checkmark schedule with predetermined reasons to stay in hospital like low bloodpressure, sedation, dizzyness, lack of physiotherapy and medical and surgical complications.
The outcome assesment will be descriptive.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start1 Nov 2021
- Primary completion22 Mar 2024
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Post Operative Pain, AcuteStudies 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
- Model description
- A double-blind randomization will be carried out, 5:5 block-randomization, half of which will be allocated to the CG and the other half to RDG. Group 1: Postoperative placebo tablet on day 1 after surgery. Group 2: Postoperative dexamethasone 24 mg tablet on day 1 after surgery.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563155
- Sponsor's protocol ID
- Repeat Dose
- Status last verified
- Jun 2024
- First submitted
- 16 Sep 2022
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes The individual patient data will be made available in anonymized form.
Publications
Pabinger C, Lothaller H, Portner N, Geissler A. Projections of hip arthroplasty in OECD countries up to 2050. Hip Int. 2018 Sep;28(5):498-506. doi: 10.1177/1120700018757940. Epub 2018 May 21.
PubMed 29783896Erivan R, Villatte G, Dartus J, Reina N, Descamps S, Boisgard S. Progression and projection for hip surgery in France, 2008-2070: Epidemiologic study with trend and projection analysis. Orthop Traumatol Surg Res. 2019 Nov;105(7):1227-1235. doi: 10.1016/j.otsr.2019.07.021. Epub 2019 Oct 9.
PubMed 31606338Romanini E, Decarolis F, Luzi I, Zanoli G, Venosa M, Laricchiuta P, Carrani E, Torre M. Total knee arthroplasty in Italy: reflections from the last fifteen years and projections for the next thirty. Int Orthop. 2019 Jan;43(1):133-138. doi: 10.1007/s00264-018-4165-7. Epub 2018 Oct 6.
PubMed 30293141Sloan M, Premkumar A, Sheth NP. Projected Volume of Primary Total Joint Arthroplasty in the U.S., 2014 to 2030. J Bone Joint Surg Am. 2018 Sep 5;100(17):1455-1460. doi: 10.2106/JBJS.17.01617.
PubMed 30180053Gromov K, Kjaersgaard-Andersen P, Revald P, Kehlet H, Husted H. Feasibility of outpatient total hip and knee arthroplasty in unselected patients. Acta Orthop. 2017 Oct;88(5):516-521. doi: 10.1080/17453674.2017.1314158. Epub 2017 Apr 20.
PubMed 28426262Chan EY, Blyth FM, Nairn L, Fransen M. Acute postoperative pain following hospital discharge after total knee arthroplasty. Osteoarthritis Cartilage. 2013 Sep;21(9):1257-63. doi: 10.1016/j.joca.2013.06.011.
PubMed 23973139Andersen LO, Gaarn-Larsen L, Kristensen BB, Husted H, Otte KS, Kehlet H. Subacute pain and function after fast-track hip and knee arthroplasty. Anaesthesia. 2009 May;64(5):508-13. doi: 10.1111/j.1365-2044.2008.05831.x.
PubMed 19413820Lavand'homme P. Transition from acute to chronic pain after surgery. Pain. 2017 Apr;158 Suppl 1:S50-S54. doi: 10.1097/j.pain.0000000000000809. No abstract available.
PubMed 28134653Lavand'homme PM, Grosu I, France MN, Thienpont E. Pain trajectories identify patients at risk of persistent pain after knee arthroplasty: an observational study. Clin Orthop Relat Res. 2014 May;472(5):1409-15. doi: 10.1007/s11999-013-3389-5.
PubMed 24258688Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
PubMed 16698416Sullivan M, Bishop S, Pivik J. The pain catastrophizing scale: development and validation. Psychol Assess 1995; 7: 524-32
Khan RS, Ahmed K, Blakeway E, Skapinakis P, Nihoyannopoulos L, Macleod K, Sevdalis N, Ashrafian H, Platt M, Darzi A, Athanasiou T. Catastrophizing: a predictive factor for postoperative pain. Am J Surg. 2011 Jan;201(1):122-31. doi: 10.1016/j.amjsurg.2010.02.007. Epub 2010 Sep 15.
PubMed 20832052Xu H, Zhang S, Xie J, Lei Y, Cao G, Pei F. Multiple Doses of Perioperative Dexamethasone Further Improve Clinical Outcomes After Total Knee Arthroplasty: A Prospective, Randomized, Controlled Study. J Arthroplasty. 2018 Nov;33(11):3448-3454. doi: 10.1016/j.arth.2018.06.031. Epub 2018 Jul 4.
PubMed 30033064Li D, Zhao J, Yang Z, Kang P, Shen B, Pei F. Multiple Low Doses of Intravenous Corticosteroids to Improve Early Rehabilitation in Total Knee Arthroplasty: A Randomized Clinical Trial. J Knee Surg. 2019 Feb;32(2):171-179. doi: 10.1055/s-0038-1636506. Epub 2018 Mar 7.
PubMed 29514368Xu B, Ma J, Huang Q, Huang ZY, Zhang SY, Pei FX. Two doses of low-dose perioperative dexamethasone improve the clinical outcome after total knee arthroplasty: a randomized controlled study. Knee Surg Sports Traumatol Arthrosc. 2018 May;26(5):1549-1556. doi: 10.1007/s00167-017-4506-x. Epub 2017 May 4.
PubMed 28474088
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeat Dose Steroid to Prevent Pain Relapse After Total Knee Arthroplasty in Patients With High Pain Response - A Randomized Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05563155
- Acronym / sponsor ID
- Repeat Dose
- Conditions
- Post Operative Pain, Acute
- Keywords
- Dexamethason, repeat, glucocorticoids, TKA surgery, steroids, High Pain Responders, postoperative pain, repeat dosing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 3 Oct 2022 (actual)
- 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.
The aim of the study is to compare the effect of a repeat moderate dose of glucocorticoids postoperatively after preoperative high dose upon postoperative pain after Total Knee Arthroplasty (TKA) in an High Pain Respondes (HPR) population to a standard single high dose systemic preoperative administration in an HPR population.
As a standard procedure, all patients referred to the outpatient clinic due to suspected degenerative knee disease will be asked to fulfill the Pain Catastrophizing Scale (PCS). If TKA is decided, patients with a PCS score above 20 will be treated with intravenously administered Dexamethasone 1 mg/kg as a rounded-up-dose to closest 10 mg according to our guideline for FAST-TRACK TKA.
The repeat-dosing group (RDG) will receive a dose of 24 mg dexamethasone tablets at 9-11 pm on the first postoperative day. The control-group (CG) will receive placebo tablets at 9-11 pm on the first postoperative day.
Detailed description
Total hip and knee arthroplasty (THA/TKA) are frequently performed procedures and are expected to increase in numbers along with the growing elderly population the next decade.
Total Knee Arthroplasty (TKA) is suitable for FAST-TRACK surgery, and is often performed as outpatient surgery with no hospital overnight stay.
Challenges in FAST-TRACK surgery include postoperative pain, nausea and vomiting (PONV), complications due to rescue-analgesics and surgical complications.
Pain is a well-known clinical problem, with up to 75% of TKA patients experiencing moderate to severe pain the first day after surgery, and 30-40% still experiencing moderate to severe pain 2 weeks after surgery, potentially delaying ambulation and recovery within the first weeks.
The role of severe acute postoperative pain upon the development of chronic pain is debatable, but important.
Data from our recently finished study in High Pain Responders (HPR), defined as patients with a score above 20 on the Pain Catastrophizing Scale (PCS), receiving preoperative high dose dexamethasone (Nielsen et al.: IN PREPARATION, clinicaltrials.gov ID NCT03763734, EudraCT 2018-002635-23, VEK H-18034778) found a persistent moderate to severe pain in 40 % of patients, at time 48 hours after surgery, corresponding to the time when the physiological effect of our dexamethasone intervention declines.
Moderate to severe pain (Visual analogue scale (VAS >30)) 24 hours postoperatively during a 5-meter walk test was associated with relapse pain at 48 hours.
Other studies have made attempts of investigating the effect of a repeated dose of steroids after TKA and Total Hip Arthroplasty (THA), but all have done so with a postoperative injection of low dose steroids. No previous studies have, to our knowledge, investigated the effects of repeat dosing after a preoperative high dose of steroid, and none focused on patients selected by their postoperative pain response. In spite of many studies and systematic reviews on the subject, the optimal timing and dose for steroid-intervention in TKA in different patient groups is still inadequately understood
The study conduct with a repeat moderate dose of steroids given as an oral tablet at 9-11 pm on the day after TKA surgery in patients receiving preoperative high dose steroids, who have a high postoperative pain response, in a FAST-TRACK perioperative setting. Oral administration of the repeat dose will allow for possible early discharge in future clinical settings.
The hypothesis is that a repeat moderate dose of glucocorticoid will reduce the postoperative pain on postoperative day 2 and cumulated pain day 2-3 after TKA surgery, when compared to single high dose preoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind randomization will be carried out, 5:5 block-randomization, half of which will be allocated to the CG and the other half to RDG. Group 1: Postoperative placebo tablet on day 1 after surgery. Group 2: Postoperative dexamethasone 24 mg tablet on day 1 after surgery.
| Arm | Type | Receives |
|---|---|---|
| Placebo tablet on day 1 after surgery given as one single dose. | Placebo comparator | Drug: PlaceboControl Group (CG): Intervention: Postoperative oral placebo tablet on day 1 after surgery given as one single dose. |
| Dexamethasone 24 mg on day 1 after surgery given as one single dose. | Active comparator | Drug: Dexamethasone 24 mgRepeat Dose Group (RDG): Intervention: Postoperative oral dexamethasone 24 mg on day 1 after surgery given as one single dose. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 40 years.
- Primary unilateral TKA.
- Ability to participate in the study (understand written and spoken Danish language, self-reported pain and satisfaction).
- Signed written informed consent form.
- PCS >20.
Key exclusion criteria (9 listed)
- Ongoing treatment of systemic glucocorticoids or other immunosuppressant treatment apart from inhaled steroids.
- Insulin-dependent diabetes.
- Pregnancy or breastfeeding.*
- Allergies concerning the study-drug.
- Mental disability that could impair a patient's decision-making capability of giving informed consent and not enabling valid data collection.
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 |
|---|---|---|
| Dexamethasone 24 mgAlso: Dexa-ratiopharmDexamethasone 24 mg on day 1 after surgery. | Drug | Dexamethasone 24 mg on day 1 after surgery given as one single dose. |
| PlaceboPlacebo tablet given on day 1 after surgery. | Drug | Placebo tablet on day 1 after surgery given as one single dose. |
Primary outcome
Postoperative pain after 48 hours / day 2 morning, according to VAS-scale
Time frame: Day 2 morning
The amount of patients with moderate postoperative pain in a 5 meter walk test day 2 morgning(48 hours) postoperatively after total knee-arthroplasty. Pain is monitored by the Visual Analog Scale(VAS) 0-100 mm, where 0 is no pain and 100 mm is the worst pain. Moderate pain is considered a VAS >30 mm.
8 secondary outcomes
Cumulated pain upon ambulation, according to VAS-scale (0-100mm), in a 5-meter walk test
Time frame: From day 2-3
Cumulated pain score, according to VAS-scale (0-100mm), at rest, upon ambulation in a 5-meter walk test and at night according to VAS-scale(0-100mm)
Time frame: From day 2-7
Quality of sleep, lethargy, dizziness, and nausea postoperative registration, according to the VAS-scale(0-100mm)
Time frame: From day 2-7
Cumulative use of rescue analgesics per day.
Time frame: From day 2-7
Patient satisfaction with analgesic regimen in a ordinal scale from 0 to 10
Time frame: Day 7
Number of re-admissions within 30 days, and reasons why (follow-up by EPJ on postoperative day 30)
Time frame: Day 30
Morbidity and mortality (30-day follow-up by EPJ or telephone).
Time frame: Day 30
Why still in hospital, an audit into the reasons the patient has not yet been discharged from the ward
Time frame: Day 7
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 28 Jun 2024.
- Background: PubMed 29783896Pabinger C, Lothaller H, Portner N, Geissler A. Projections of hip arthroplasty in OECD countries up to 2050. Hip Int. 2018 Sep;28(5):498-506. doi: 10.1177/1120700018757940. Epub 2018 May 21.
- Background: PubMed 31606338Erivan R, Villatte G, Dartus J, Reina N, Descamps S, Boisgard S. Progression and projection for hip surgery in France, 2008-2070: Epidemiologic study with trend and projection analysis. Orthop Traumatol Surg Res. 2019 Nov;105(7):1227-1235. doi: 10.1016/j.otsr.2019.07.021. Epub 2019 Oct 9.
- Background: PubMed 30293141Romanini E, Decarolis F, Luzi I, Zanoli G, Venosa M, Laricchiuta P, Carrani E, Torre M. Total knee arthroplasty in Italy: reflections from the last fifteen years and projections for the next thirty. Int Orthop. 2019 Jan;43(1):133-138. doi: 10.1007/s00264-018-4165-7. Epub 2018 Oct 6.
- Background: PubMed 30180053Sloan M, Premkumar A, Sheth NP. Projected Volume of Primary Total Joint Arthroplasty in the U.S., 2014 to 2030. J Bone Joint Surg Am. 2018 Sep 5;100(17):1455-1460. doi: 10.2106/JBJS.17.01617.
- Background: PubMed 28426262Gromov K, Kjaersgaard-Andersen P, Revald P, Kehlet H, Husted H. Feasibility of outpatient total hip and knee arthroplasty in unselected patients. Acta Orthop. 2017 Oct;88(5):516-521. doi: 10.1080/17453674.2017.1314158. Epub 2017 Apr 20.
- Background: PubMed 23973139Chan EY, Blyth FM, Nairn L, Fransen M. Acute postoperative pain following hospital discharge after total knee arthroplasty. Osteoarthritis Cartilage. 2013 Sep;21(9):1257-63. doi: 10.1016/j.joca.2013.06.011.
- Background: PubMed 19413820Andersen LO, Gaarn-Larsen L, Kristensen BB, Husted H, Otte KS, Kehlet H. Subacute pain and function after fast-track hip and knee arthroplasty. Anaesthesia. 2009 May;64(5):508-13. doi: 10.1111/j.1365-2044.2008.05831.x.
- Background: PubMed 28134653Lavand'homme P. Transition from acute to chronic pain after surgery. Pain. 2017 Apr;158 Suppl 1:S50-S54. doi: 10.1097/j.pain.0000000000000809. No abstract available.
- Background: PubMed 24258688Lavand'homme PM, Grosu I, France MN, Thienpont E. Pain trajectories identify patients at risk of persistent pain after knee arthroplasty: an observational study. Clin Orthop Relat Res. 2014 May;472(5):1409-15. doi: 10.1007/s11999-013-3389-5.
- Background: PubMed 16698416Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
- BackgroundSullivan M, Bishop S, Pivik J. The pain catastrophizing scale: development and validation. Psychol Assess 1995; 7: 524-32
- Background: PubMed 20832052Khan RS, Ahmed K, Blakeway E, Skapinakis P, Nihoyannopoulos L, Macleod K, Sevdalis N, Ashrafian H, Platt M, Darzi A, Athanasiou T. Catastrophizing: a predictive factor for postoperative pain. Am J Surg. 2011 Jan;201(1):122-31. doi: 10.1016/j.amjsurg.2010.02.007. Epub 2010 Sep 15.
- Individual participant dataSharing planned: Yes. Yes The individual patient data will be made available in anonymized form.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dexamethasone 24 mg in people with Post Operative Pain, Acute, run by Vejle Hospital at 1 site 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 6 inclusion and 9 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 28 Jun 2024. 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 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?
Postoperative pain after 48 hours / day 2 morning, according to VAS-scale (time frame: Day 2 morning). 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 NCT05563155, which also lists 27 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 28 Jun 2024.