Arthropathy of KneePhase 3NCT04084912
Effect of Preoperative Steroid in Total Knee Arthroplasty
A Phase 3 study testing Dexamethasone Sodium Phosphate and Saline Solution in people with Arthropathy of Knee, run by Assiut University.
Trial summary
Detect the effect of preoperative steroid injection in total knee arthroplasty on post operative: 1. pain 2. oedema 3. nausea and vomiting 4. quadriceps power 5. knee flexion 6. wound complications Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Arthropathy of Knee
- What is being tested?
- Dexamethasone Sodium Phosphate and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 1 Jun 2021
- Phase
- Phase 3
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Any patient scheduled for primary total knee replacement arthroplasty
Who cannot join
- Diabetic patients
- Rheumatoid arthritis patients
- Patients on regular steroid therapy
- Patients refused to be enrolled in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Preoperative Steroids Injection on Pain and Oedema After Total Knee Arthroplasty . A Double -Blinded Randomized Controlled Study.
Detect the effect of preoperative steroid injection in total knee arthroplasty on post operative:
- pain
- oedema
- nausea and vomiting
- quadriceps power
- knee flexion
- wound complications
Read the detailed description
Total knee arthroplasty has been identified as one of the most effective surgeries for knee arthritis. Many patients experience moderate to severe pain during the early postoperative period, as the surgery involves extensive bone resection and postsurgical serum levels of cytokine interleukin-6 and C-reactive protein may be elevated.Furthermore, many patients suffer postoperative nausea and vomiting after total knee arthroplasty . The inflammatory response after TKA is pronounced and a result of cumulative effects of anaesthesia and mechanical stress . Inadequate management of postoperative pain is relevant with a series of undesirable effects, including progression to a persistent pain, delayed functional recovery, increased the economic burden and patient dissatisfaction. Steroids may be associated with decreased levels of interleukin-6 and C reactive protein and may, thus, relieve the pain associated with surgery. Dexamethasone is a long-acting glucocorticoid that has been reported to inhibit peripheral phospholipase A, which decreases the pain-aggravating agents from the cyclooxygenase and lipoxygenase pathways . In addition, it reduces postoperative nausea and vomiting by exerting a central antiemetic effect by inhibiting prostaglandin synthesis and the release of endogenous opioids[5] . Some studies also reported potential adverse events, such as infection .
- Conditions
- Arthropathy of Knee
- Being tested
- Dexamethasone Sodium Phosphate, Saline Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Sodium PhosphateDrug
Also called Steroid
intravenous injection of one ampoule dexamethasone Sodium phosphate 2 ml 8 mg
Saline SolutionDrug
Also called saline
intravenous injection of one ampoule saline
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone group | Active comparator | this group will receive one ampoule Intravenous injection of Dexamethasone Sodium Phosphate 2 ml . 8 mg once by the anesthesiologist immediately before skin incision Receives: Drug: Dexamethasone Sodium Phosphate |
| Placebo group | Placebo comparator | this group will receive one ampoule Intravenous injection of Saline once by the anesthesiologist immediately before skin incision Receives: Drug: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain summarized in the first 14 days
postoperative pain summarized over first 14 days after surgery , assessed by a summation of Visual Analog Scale (VAS)-scores at day 1 , day 2 , day 3 and day 14 after surgery pain is monitored by Visual Analog Scale (VAS) 0-100 mm, where 0 is no pain and 100 is the worst pain one can imagine Moderate pain is considered a VAS >30 mm.
Measured: 14 days
Secondary outcomes (4)
Postoperative Thigh circumference in the first 14 days
Postoperative oedema will be assessed for all participants by measuring Thigh circumference 1 cm above the upper pole of the patella postoperatively at day 1,2,3 and 14
Measured: 14 days
postoperative nausea and vomiting in the first 14 days
postoperative nausea and vomiting summarized over first 14 days after surgery , assessed by a summation of Visual Analog Scale (VAS)-scores at day 1 , day 2 , day 3 and day 14 after surgery Nausea and vomiting is monitored by Visual Analog Scale (VAS) 0-100 mm, where 0 is no nausea nor vomiting and 100 is the worst nausea and vomiting one can imagine Moderate pain is considered a VAS >30 mm.
Measured: 14 days
postoperative knee flexion in the first 14 days
Knee flexion assessed over first 14 days after surgery assessed by knee range of motion measured by goniometer where straight knee joint measure 0 degree.
Measured: 14 days
Surgical wound infection in the first 14 days
wound complications like infection to be reported: redness, discharge, infection, dehiscence, delayed healing (up to 2 wks) postoperatively
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Arthropathy of KneeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DNKameel, Assiut University
- Investigators
- Hatem Bakr, asst. prof, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084912
- Sponsor's protocol ID
- steroid injection in TKA
- Status last verified
- Dec 2019
- First submitted
- 5 Sep 2019
- Last updated
- 23 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xing LZ, Li L, Zhang LJ. Can intravenous steroid administration reduce postoperative pain scores following total knee arthroplasty?: A meta-analysis. Medicine (Baltimore). 2017 Jun;96(24):e7134. doi: 10.1097/MD.0000000000007134.
PubMed 28614237Rytter S, Stilling M, Munk S, Hansen TB. Methylprednisolone reduces pain and decreases knee swelling in the first 24 h after fast-track unicompartmental knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017 Jan;25(1):284-290. doi: 10.1007/s00167-014-3501-8. Epub 2015 Jan 7.
PubMed 25564196Fan Z, Ma J, Kuang M, Zhang L, Han B, Yang B, Wang Y, Ma X. The efficacy of dexamethasone reducing postoperative pain and emesis after total knee arthroplasty: A systematic review and meta-analysis. Int J Surg. 2018 Apr;52:149-155. doi: 10.1016/j.ijsu.2018.02.043. Epub 2018 Feb 23.
PubMed 29481989Meng J, Li L. The efficiency and safety of dexamethasone for pain control in total joint arthroplasty: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2017 Jun;96(24):e7126. doi: 10.1097/MD.0000000000007126.
PubMed 28614232Yue C, Wei R, Liu Y. Perioperative systemic steroid for rapid recovery in total knee and hip arthroplasty: a systematic review and meta-analysis of randomized trials. J Orthop Surg Res. 2017 Jun 27;12(1):100. doi: 10.1186/s13018-017-0601-4.
PubMed 28655354
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Steroids Injection on Pain and Oedema After Total Knee Arthroplasty . A Double -Blinded Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04084912
- Acronym / sponsor ID
- steroid injection in TKA
- Conditions
- Arthropathy of Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 10 Sep 2019 (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.
Detect the effect of preoperative steroid injection in total knee arthroplasty on post operative:
- pain
- oedema
- nausea and vomiting
- quadriceps power
- knee flexion
- wound complications
Detailed description
Total knee arthroplasty has been identified as one of the most effective surgeries for knee arthritis. Many patients experience moderate to severe pain during the early postoperative period, as the surgery involves extensive bone resection and postsurgical serum levels of cytokine interleukin-6 and C-reactive protein may be elevated.Furthermore, many patients suffer postoperative nausea and vomiting after total knee arthroplasty . The inflammatory response after TKA is pronounced and a result of cumulative effects of anaesthesia and mechanical stress . Inadequate management of postoperative pain is relevant with a series of undesirable effects, including progression to a persistent pain, delayed functional recovery, increased the economic burden and patient dissatisfaction. Steroids may be associated with decreased levels of interleukin-6 and C reactive protein and may, thus, relieve the pain associated with surgery. Dexamethasone is a long-acting glucocorticoid that has been reported to inhibit peripheral phospholipase A, which decreases the pain-aggravating agents from the cyclooxygenase and lipoxygenase pathways . In addition, it reduces postoperative nausea and vomiting by exerting a central antiemetic effect by inhibiting prostaglandin synthesis and the release of endogenous opioids[5] . Some studies also reported potential adverse events, such as infection .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone group | Active comparator | Drug: Dexamethasone Sodium Phosphatethis group will receive one ampoule Intravenous injection of Dexamethasone Sodium Phosphate 2 ml . 8 mg once by the anesthesiologist immediately before skin incision |
| Placebo group | Placebo comparator | Drug: Saline Solutionthis group will receive one ampoule Intravenous injection of Saline once by the anesthesiologist immediately before skin incision |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient scheduled for primary total knee replacement arthroplasty
Key exclusion criteria (4 listed)
- Diabetic patients
- Rheumatoid arthritis patients
- Patients on regular steroid therapy
- Patients refused to be enrolled in the study
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 Sodium PhosphateAlso: Steroidintravenous injection of one ampoule dexamethasone Sodium phosphate 2 ml 8 mg | Drug | Dexamethasone group |
| Saline SolutionAlso: salineintravenous injection of one ampoule saline | Drug | Placebo group |
Primary outcome
Postoperative pain summarized in the first 14 days
Time frame: 14 days
postoperative pain summarized over first 14 days after surgery , assessed by a summation of Visual Analog Scale (VAS)-scores at day 1 , day 2 , day 3 and day 14 after surgery pain is monitored by Visual Analog Scale (VAS) 0-100 mm, where 0 is no pain and 100 is the worst pain one can imagine Moderate pain is considered a VAS >30 mm.
4 secondary outcomes
Postoperative Thigh circumference in the first 14 days
Time frame: 14 days
postoperative nausea and vomiting in the first 14 days
Time frame: 14 days
postoperative knee flexion in the first 14 days
Time frame: 14 days
Surgical wound infection in the first 14 days
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Background: PubMed 28614237Xing LZ, Li L, Zhang LJ. Can intravenous steroid administration reduce postoperative pain scores following total knee arthroplasty?: A meta-analysis. Medicine (Baltimore). 2017 Jun;96(24):e7134. doi: 10.1097/MD.0000000000007134.
- Background: PubMed 25564196Rytter S, Stilling M, Munk S, Hansen TB. Methylprednisolone reduces pain and decreases knee swelling in the first 24 h after fast-track unicompartmental knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017 Jan;25(1):284-290. doi: 10.1007/s00167-014-3501-8. Epub 2015 Jan 7.
- Background: PubMed 29481989Fan Z, Ma J, Kuang M, Zhang L, Han B, Yang B, Wang Y, Ma X. The efficacy of dexamethasone reducing postoperative pain and emesis after total knee arthroplasty: A systematic review and meta-analysis. Int J Surg. 2018 Apr;52:149-155. doi: 10.1016/j.ijsu.2018.02.043. Epub 2018 Feb 23.
- Background: PubMed 28614232Meng J, Li L. The efficiency and safety of dexamethasone for pain control in total joint arthroplasty: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2017 Jun;96(24):e7126. doi: 10.1097/MD.0000000000007126.
- Background: PubMed 28655354Yue C, Wei R, Liu Y. Perioperative systemic steroid for rapid recovery in total knee and hip arthroplasty: a systematic review and meta-analysis of randomized trials. J Orthop Surg Res. 2017 Jun 27;12(1):100. doi: 10.1186/s13018-017-0601-4.
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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.
Hatem Bakr, asst. prof study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone Sodium Phosphate and Saline Solution in people with Arthropathy of Knee, run by Assiut University.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Nady, physician (+2001203649367, david011183@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain summarized in the first 14 days (time frame: 14 days). 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 NCT04084912, which also lists 5 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 23 Dec 2019.