Postoperative PainPhase 4NCT03763734
High-Dose Steroid for Knee Arthroplasty Patients Expected to Have Postoperative Pain
A Phase 4 study testing Dexamethasone in people with Postoperative Pain and Postoperative Nausea and Vomiting, run by Copenhagen University Hospital, Hvidovre at 2 sites in Denmark.
Trial summary
The purpose of the Study is to test a higher dose of steroids(Dexamethasone) given just prior to surgery in the setting of Fast-Track Knee surgery with Arthroplasty in a group of expected High Pain Responders and the effect on postoperative pain and postoperative inflammation. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Postoperative Pain, Postoperative Nausea and Vomiting, Knee Osteoarthritis
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesDenmark
- Study dates
- 29 Jan 2019to 1 Jan 2021
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 and 90.
- Booked for unilateral knee-arthroplasty.
- Is able to take part in the investigation(selfreported pain and nausea/vomiting)
- Understands Danish or English, or has a translator available.
- Signed written consent.
- A daily use of 30 mg or more of morphine or morphine equivalents .
- A pain catastrophizing scale(PCS) score of >20.
Who cannot join
- Insulin-dependent diabetes melitus.
- Ongoing treatment with systemic glucocorticoids or immunosuppressing treatment(apart from inhaled glucocorticoids).
- Pregnancy/Breastfeeding
- Allergies for the investigational drug.
- A history of schizophrenia or bipolar diseases, or patients with permanent use of antipsychotic medication.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Hvidovre Hospital, Capital Region of Denmark.
Hvidovre, 2650
Vejle Sygehus
Vejle, 7100
About this study
Official title: High-Dose Steroids in High Pain Responders Undergoing Total Knee-arthroplasty: A Randomized Double Blinded Controlled Trial
The purpose of the Study is to test a higher dose of steroids(Dexamethasone) given just prior to surgery in the setting of Fast-Track Knee surgery with Arthroplasty in a group of expected High Pain Responders and the effect on postoperative pain and postoperative inflammation.
Read the detailed description
This study compares a new High-Dose dosage of steroids in the treatment of postoperative pain after Knee Arthroplasty in a Fast-Track setting in a group of expected High Pain Responders.
The investigators compare the already used dose(medium dose) with a new high dose(HD) steroid given as an intravenous bolus after the spinal anaesthesia has been given, but before the surgery starts.
The hypothesis is that by attenuating the inflammatory response to the surgery itself by the steroid Dexamethasone, the investigators expect a reduction in postoperative pain upon ambulation 24 hours after unilateral Knee Arthroplasty.
Patients referred to Unilateral Total KneeArthroplasty because of knee-osteoarthritis at Hvidovre Hospital, Capital Region of Denmark or Vejle Hospital, South Region of Denmark are screened and offered inclusion in the study.
The two groups will be randomized and double blinded. One group will be treated, as the current guideline in the investigator's Orthopedic fast-track Arthroplasty center, with the medium dose of steroid (0,3 mg dexamethasone/kg bodyweight).
The other group wil be treated with a high dose of steroid (1,0 mg dexamethasone/kg bodyweight).
The patients will be monitored the first 7 days after surgery, during the admission to the hospital, and by a Pain-diary in the patients own home.
Blood tests will be taken preoperatively and postoperatively to determine the effect of the highdose steroid on the inflammatory response.
- Conditions
- Postoperative Pain, Postoperative Nausea and Vomiting, Knee Osteoarthritis, Perioperative/Postoperative Complications, Surgery, Opioid Use
- Being tested
- Dexamethasone
- Keywords
- Knee Arthroplasty, Knee Replacement, Perioperative Medicine
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Osteoarthritis, Knee, Postoperative Complications, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Dexa-ratiopharm
An intravenous bolus dose of dexamethasone given prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| High dose Dexamethasone | Experimental | An intravenous bolus dose of Dexamethasone 1 mg/kg bodyweight administered preoperatively before surgery. Receives: Drug: Dexamethasone |
| Medium dose Dexamethasone | Active comparator | An intravenous bolus dose of Dexamethasone 0,3 mg/kg bodyweight administered preoperatively before surgery. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain after 24 hours: VAS
The amount of patients with moderate postoperative pain in a 5 meter walk test 24 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: 24 hours
Secondary outcomes (4)
Postoperative opioid usage
The amount of rescue opioids given in the postoperative period, and until 7 days after surgery.
Measured: 7 days
Postoperative antiemetics usage
The amount of rescue antiemetics given in the postoperative period, and until 7 days after surgery.
Measured: 7 days
The inflammatory response expressed by C-reactive protein(CRP).
The inflammatory response is monitored by the blood-sample c-reactive protein(CRP) and analyzed to se the possible attenuation of the response because of dexamethasone.
Measured: 2 days
Postoperative pain summarized in the first 7 days
Pain summarized over the first 7 days after surgery, assessed by a summation of the Visual Analog Scale(VAS)-scores in the first 7 days as noted in the pain diary filed in by the participants.
Pain is monitored by the Visual Analog Scale(VAS) 0-100 mm, where 0 is no pain and 100 mm is the worst pain one can imagine. Moderate pain is considered a VAS >30 mm.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start29 Jan 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- A randomized double blinded controlled trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Collaborators
- Sygehus Lillebaelt
- Responsible party
- Principal investigator, Niklas Ingemann Nielsen, Copenhagen University Hospital, Hvidovre
- Investigators
- Nicolai Bang Foss, Dr.med., Study director, Dept. of Anaesthesia, Hvidovre Hospital, Capital Region of Denmark.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763734
- Sponsor's protocol ID
- NBF_HK_02_2018
- Status last verified
- Jun 2021
- First submitted
- 28 Nov 2018
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nielsen NI, Kehlet H, Gromov K, Troelsen A, Husted H, Varnum C, Kjaersgaard-Andersen P, Rasmussen LE, Pleckaitiene L, Foss NB. High-dose steroids in high pain responders undergoing total knee arthroplasty: a randomised double-blind trial. Br J Anaesth. 2022 Jan;128(1):150-158. doi: 10.1016/j.bja.2021.10.001. Epub 2021 Nov 5.
PubMed 34749994
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Dose Steroids in High Pain Responders Undergoing Total Knee-arthroplasty: A Randomized Double Blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT03763734
- Acronym / sponsor ID
- NBF_HK_02_2018
- Conditions
- Postoperative Pain, Postoperative Nausea and Vomiting, Knee Osteoarthritis, Perioperative/Postoperative Complications, Surgery, Opioid Use
- Keywords
- Knee Arthroplasty, Knee Replacement, Perioperative Medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Collaborators
- Sygehus Lillebaelt
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 4 Dec 2018 (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 purpose of the Study is to test a higher dose of steroids(Dexamethasone) given just prior to surgery in the setting of Fast-Track Knee surgery with Arthroplasty in a group of expected High Pain Responders and the effect on postoperative pain and postoperative inflammation.
Detailed description
This study compares a new High-Dose dosage of steroids in the treatment of postoperative pain after Knee Arthroplasty in a Fast-Track setting in a group of expected High Pain Responders.
The investigators compare the already used dose(medium dose) with a new high dose(HD) steroid given as an intravenous bolus after the spinal anaesthesia has been given, but before the surgery starts.
The hypothesis is that by attenuating the inflammatory response to the surgery itself by the steroid Dexamethasone, the investigators expect a reduction in postoperative pain upon ambulation 24 hours after unilateral Knee Arthroplasty.
Patients referred to Unilateral Total KneeArthroplasty because of knee-osteoarthritis at Hvidovre Hospital, Capital Region of Denmark or Vejle Hospital, South Region of Denmark are screened and offered inclusion in the study.
The two groups will be randomized and double blinded. One group will be treated, as the current guideline in the investigator's Orthopedic fast-track Arthroplasty center, with the medium dose of steroid (0,3 mg dexamethasone/kg bodyweight).
The other group wil be treated with a high dose of steroid (1,0 mg dexamethasone/kg bodyweight).
The patients will be monitored the first 7 days after surgery, during the admission to the hospital, and by a Pain-diary in the patients own home.
Blood tests will be taken preoperatively and postoperatively to determine the effect of the highdose steroid on the inflammatory response.
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 randomized double blinded controlled trial.
| Arm | Type | Receives |
|---|---|---|
| High dose Dexamethasone | Experimental | Drug: DexamethasoneAn intravenous bolus dose of Dexamethasone 1 mg/kg bodyweight administered preoperatively before surgery. |
| Medium dose Dexamethasone | Active comparator | Drug: DexamethasoneAn intravenous bolus dose of Dexamethasone 0,3 mg/kg bodyweight administered preoperatively before surgery. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 40 and 90.
- Booked for unilateral knee-arthroplasty.
- Is able to take part in the investigation(selfreported pain and nausea/vomiting)
- Understands Danish or English, or has a translator available.
- Signed written consent.
Key exclusion criteria (5 listed)
- Insulin-dependent diabetes melitus.
- Ongoing treatment with systemic glucocorticoids or immunosuppressing treatment(apart from inhaled glucocorticoids).
- Pregnancy/Breastfeeding
- Allergies for the investigational drug.
- A history of schizophrenia or bipolar diseases, or patients with permanent use of antipsychotic medication.
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 |
|---|---|---|
| DexamethasoneAlso: Dexa-ratiopharmAn intravenous bolus dose of dexamethasone given prior to surgery. | Drug | High dose Dexamethasone, Medium dose Dexamethasone |
Primary outcome
Postoperative pain after 24 hours: VAS
Time frame: 24 hours
The amount of patients with moderate postoperative pain in a 5 meter walk test 24 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.
4 secondary outcomes
Postoperative opioid usage
Time frame: 7 days
Postoperative antiemetics usage
Time frame: 7 days
The inflammatory response expressed by C-reactive protein(CRP).
Time frame: 2 days
Postoperative pain summarized in the first 7 days
Time frame: 7 days
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 30 Jun 2021.
- Derived from this study: PubMed 34749994Nielsen NI, Kehlet H, Gromov K, Troelsen A, Husted H, Varnum C, Kjaersgaard-Andersen P, Rasmussen LE, Pleckaitiene L, Foss NB. High-dose steroids in high pain responders undergoing total knee arthroplasty: a randomised double-blind trial. Br J Anaesth. 2022 Jan;128(1):150-158. doi: 10.1016/j.bja.2021.10.001. Epub 2021 Nov 5.
- Individual participant dataSharing planned: No
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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.
Nicolai Bang Foss, Dr.med. study director
Dept. of Anaesthesia, Hvidovre Hospital, Capital Region of Denmark.
2 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 Dexamethasone in people with Postoperative Pain and Postoperative Nausea and Vomiting, run by Copenhagen University Hospital, Hvidovre at 2 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 7 inclusion and 5 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 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 24 hours: VAS (time frame: 24 hours). 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 NCT03763734, which also lists 1 linked publication.
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 30 Jun 2021.