Postoperative PainPhase 4NCT02219581
Steroids in Total Knee Arthroplasty
A Phase 4 study testing Dexamethasone 10 mg, Dexamethasone 20 mg and Standard multimodal pain management regimen in people with Postoperative Pain and Inflammation, run by Thomas L Bradbury at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if the use of two small doses of intravenous (IV) steroids around the time of knee replacement surgery decrease a patient's pain or use of pain medication. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Postoperative Pain, Inflammation, Osteoarthritis
- What is being tested?
- Dexamethasone 10 mg, Dexamethasone 20 mg and Standard multimodal pain management regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2014to 1 Dec 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary total joint arthroplasty of the knee
- Adult patients ages 18-100 years
- Patients must have smart phone and/or device for app usage
Who cannot join
- Current chronic steroid use
- Patients undergoing revision knee surgery
- Patients ambulating preoperatively with assistive devices
- Patients with avascular necrosis of the operative knee
- Patients with a history of an adverse reaction to glucocorticoid steroids
- Patients unable to provide informed consent
Show all 15Show fewer
- Patients with inflammatory arthritis
- Prisoners
- Current smokers
- Patients <18 years of age
- Any patient with a complicated postoperative course that requires transfer to the Intensive Care Unit (ICU) or to another facility for further management will be removed from the study.
- Any contraindication that would prevent the patient from being treated with the standard multimodal postoperative pain management regimen History of infection of surgical knee.
- Patients with diabetes.
- Patients that have an intolerance to Toradol.
- Patients that do not have smart phone and/or device for app usage
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory Orthopedic and Spine Hospital
Tucker, Georgia, 30084
About this study
Official title: Evaluation of Intravenous Glucocorticoid Therapy in Total Knee Arthroplasty
The purpose of this study is to evaluate if the use of two small doses of intravenous (IV) steroids around the time of knee replacement surgery decrease a patient's pain or use of pain medication. The investigators will also determine if the subjects receiving the steroid will have better pain control and better postoperative outcomes after their surgery.
Read the detailed description
Adequate pain control after total knee arthroplasty (TKA) is of great importance not only to maximize patient comfort, but also to ensure optimal outcomes after surgery. This study is designed to assess whether the use of two small doses of intravenous (IV) steroids around the time of surgery decrease a patient's pain or use of pain medication. Secondly, the investigators will also determine if the use of these steroids as part of a multimodal pain management strategy leads to improved patient outcomes, including pain, nausea and vomiting, knee function and length of stay in the hospital after surgery. The study will compare the effect of two different doses of IV dexamethasone given preoperatively before TKA, when compared to placebo.
- Conditions
- Postoperative Pain, Inflammation, Osteoarthritis
- Being tested
- Dexamethasone 10 mg, Dexamethasone 20 mg, Standard multimodal pain management regimen, Placebo
- Keywords
- Osteoarthritis, Postoperative pain, Total knee arthroplasty, Orthopaedics, Inflammation
- Medical subject headings
- Pain, Postoperative, Inflammation, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 10 mgDrug
Also called Decadron
Two doses of dexamethasone 10 mg will be given intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.
Dexamethasone 20 mgDrug
Also called Decadron
Two doses of dexamethasone 20 mg will be given intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.
Standard multimodal pain management regimenDrug
The standard multimodal postoperative pain management regimen typically used for total knee arthroplasty consists of the following:
Preoperative:
- Decadron: 10 or 20mg IV x 1 2 doses, 8 hours apart (if randomized to study group)
Intraoperative:
- Ropivacaine: Given intraoperatively. Capsule, subcutaneous tissue/skin. Administered in standard fashion. (300mg)
- Toradol: 30mg q 6hr for 6 total doses. 1st dose given intraoperatively at incision. The dose is 15 mg for older patients or if creatinine clearance (CrCl) is low.
Postoperative
- Tylenol: 1000mg po q 8hr (scheduled)
- Oxycodone: 5mg or 10mg q 3-4hr prn pain, If intolerant to Oxycodone: second agent line is Hydrocodone or Oral Dilaudid
- IV Morphine (or Dilaudid): 1 or 2 mg q 2hr prn breakthrough pain
- Morphine patient-controlled analgesia (PCA): only for failure of the above
- Morphine Sulfate (MS) Contin: Use as backup prn pain
PlaceboDrug
Participants in the placebo arm will receive two doses of saline intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of placebo intravenously in addition to a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty. The first dose of placebo will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. Receives: Drug: Standard multimodal pain management regimen; Drug: Placebo |
| Dexamethasone 10 mg | Experimental | Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of 10 mg dexamethasone. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. Additionally, subjects will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty. Receives: Drug: Dexamethasone 10 mg; Drug: Standard multimodal pain management regimen |
| Dexamethasone 20 mg | Experimental | Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of 20 mg dexamethasone. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. Additionally, subjects will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty. Receives: Drug: Dexamethasone 20 mg; Drug: Standard multimodal pain management regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Post-operative pain was assessed using the well-standardized and accepted visual analog pain scale. The scale shows a series of faces ranging from a happy face at 0= "No hurt", to a crying face at 10= "Hurts worst". The participant was asked to choose the face that best describes their level of pain. Higher scores indicate higher intensities of pain.
Measured: Baseline, end of hospital stay (up to 3 days), 1, 4, and 12 months post-operatively
Opioid Analgesic Usage
The amount of post-operative opioid analgesic usage is assessed as Oral Morphine Equivalents (OME) which is the amount of an oral morphine drug that would be necessary to equal the pain treatment from opioid morphine.
Measured: 1 day post-operatively
Secondary outcomes (10)
Soft Tissue Swelling
Evaluation of soft tissue swelling uses a measurement of knee circumference at the midpoint of the patella, with the knee in the maximum amount of extension allowed by the patient.
Measured: 1 day post-operatively
Range of Motion (ROM)
Maximum passive ROM allowed by the patient will be measured using a goniometer. The ROM measurement is the amount of flexion and extension recorded in degrees. An increased ROM is indicative of better joint mobility.
Measured: Baseline, 1 day post-operatively, 1, 4, and 12 months post-operatively
Post-operative Day of Physical Therapy Clearance
The post-operative day when the participant was cleared by the physical therapy staff to go home was recorded. A shorter clearance time is indicative of better joint function.
Measured: Up to 3 days post-operatively
Antiemetic Dose Administered
Post-operative nausea and/or vomiting was assessed by the use of the antiemetic Zofran, which was administered as-needed.
Measured: Post-operative Days 1 and 2
Blood Glucose
To assess postoperative glucose levels after steroid administration, blood glucose level will be analyzed using a HemoCue testing system. Diabetes is indicated with a random blood glucose measurement of greater than 200 milligrams per deciliter (mg/dL).
Measured: Baseline, Post-operative Day 1
36-Item Short Form Health Survey (SF-36) Score
The subjects' functional ability will be assessed using the SF-36 questionnaire. The SF-36 Health Survey is a 36-item, self-reported survey of patient health and is a measure of health status. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability.
Measured: Baseline, 12 months post-operatively
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score
The KOOS, JR. instrument has 7 items assessing knee stiffness, knee pain, and daily living physical function following knee joint replacement. Responses are given on a 5-point scale where 0 = no pain or disability and 4 = extreme pain or disability. Total raw scores range from 0 to 28, where higher scores indicate increased pain or disability. Total raw scores can be converted to an interval score ranging from 0 to 100 where 0 = total knee disability and 100 = perfect knee health.
Measured: Baseline, 1, 4, and 12 months post-operatively
Length of Hospital Stay
The length of hospital stay in days is reported here. A higher number of days in the hospital indicates slower recovery.
Measured: Up to 3 days post-operatively
Number of Participants Readmitted to the Hospital
The number of participants with hospital readmissions after being discharged were recorded.
Measured: Up to 12 months post-operatively
Number of Participants With Wound Infections
The number of participants with the clinical presence of wound drainage and periprosthetic infection were recorded.
Measured: Up to 12 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study start16 Oct 2014
- Primary completion1 Dec 2015
- Study completion1 Dec 2015
Why it stopped: Terminated after considerable time in suspended state due to inadequate staffing, the COVID pandemic, and the Responsible Party leaving Emory in August 2022.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas L Bradbury
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas L Bradbury, Emory University
- Investigators
- Thomas L Bradbury, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219581
- Sponsor's protocol ID
- IRB00066081
- Status last verified
- Sep 2022
- First submitted
- 13 Aug 2014
- Last updated
- 4 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intravenous Glucocorticoid Therapy in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02219581
- Acronym / sponsor ID
- IRB00066081
- Conditions
- Postoperative Pain, Inflammation, Osteoarthritis
- Keywords
- Osteoarthritis, Postoperative pain, Total knee arthroplasty, Orthopaedics, Inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated after considerable time in suspended state due to inadequate staffing, the COVID pandemic, and the Responsible Party leaving Emory in August 2022.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Thomas L BradburyUniversity, hospital or other
- Study start
- 16 Oct 2014 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 19 Aug 2014 (estimated)
- Results
- Posted 4 Oct 2022
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 this study is to evaluate if the use of two small doses of intravenous (IV) steroids around the time of knee replacement surgery decrease a patient's pain or use of pain medication. The investigators will also determine if the subjects receiving the steroid will have better pain control and better postoperative outcomes after their surgery.
Detailed description
Adequate pain control after total knee arthroplasty (TKA) is of great importance not only to maximize patient comfort, but also to ensure optimal outcomes after surgery. This study is designed to assess whether the use of two small doses of intravenous (IV) steroids around the time of surgery decrease a patient's pain or use of pain medication. Secondly, the investigators will also determine if the use of these steroids as part of a multimodal pain management strategy leads to improved patient outcomes, including pain, nausea and vomiting, knee function and length of stay in the hospital after surgery. The study will compare the effect of two different doses of IV dexamethasone given preoperatively before TKA, when compared to placebo.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: Standard multimodal pain management regimen, Drug: PlaceboSubjects undergoing primary total joint arthroplasty of the knee will receive two doses of placebo intravenously in addition to a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty. The first dose of placebo will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. |
| Dexamethasone 10 mg | Experimental | Drug: Dexamethasone 10 mg, Drug: Standard multimodal pain management regimenSubjects undergoing primary total joint arthroplasty of the knee will receive two doses of 10 mg dexamethasone. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. Additionally, subjects will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty. |
| Dexamethasone 20 mg | Experimental | Drug: Dexamethasone 20 mg, Drug: Standard multimodal pain management regimenSubjects undergoing primary total joint arthroplasty of the knee will receive two doses of 20 mg dexamethasone. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. Additionally, subjects will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing primary total joint arthroplasty of the knee
- Adult patients ages 18-100 years
- Patients must have smart phone and/or device for app usage
Key exclusion criteria (15 listed)
- Current chronic steroid use
- Patients undergoing revision knee surgery
- Patients ambulating preoperatively with assistive devices
- Patients with avascular necrosis of the operative knee
- Patients with a history of an adverse reaction to glucocorticoid steroids
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 10 mgAlso: DecadronTwo doses of dexamethasone 10 mg will be given intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. | Drug | Dexamethasone 10 mg |
| Dexamethasone 20 mgAlso: DecadronTwo doses of dexamethasone 20 mg will be given intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. | Drug | Dexamethasone 20 mg |
| Standard multimodal pain management regimenThe standard multimodal postoperative pain management regimen typically used for total knee arthroplasty consists of the following: Preoperative: * Decadron: 10 or 20mg IV x 1 2 doses, 8 hours apart (if randomized to study group) Intraoperative: * Ropivacaine: Given intraoperatively. Capsule, subcutaneous tissue/skin. Administered in standard fashion. (300mg) * Toradol: 30mg q 6hr for 6 total doses. 1st dose given intraoperatively at incision. The dose is 15 mg for older patients or if creatinine clearance (CrCl) is low. Postoperative * Tylenol: 1000mg po q 8hr (scheduled) * Oxycodone: 5mg or 10mg q 3-4hr prn pain, If intolerant to Oxycodone: second agent line is Hydrocodone or Oral Dilaudid * IV Morphine (or Dilaudid): 1 or 2 mg q 2hr prn breakthrough pain * Morphine patient-controlled analgesia (PCA): only for failure of the above * Morphine Sulfate (MS) Contin: Use as backup prn pain | Drug | Dexamethasone 10 mg, Dexamethasone 20 mg, Placebo |
| PlaceboParticipants in the placebo arm will receive two doses of saline intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. | Drug | Placebo |
Primary outcome
Pain Score
Time frame: Baseline, end of hospital stay (up to 3 days), 1, 4, and 12 months post-operatively
Post-operative pain was assessed using the well-standardized and accepted visual analog pain scale. The scale shows a series of faces ranging from a happy face at 0= "No hurt", to a crying face at 10= "Hurts worst". The participant was asked to choose the face that best describes their level of pain. Higher scores indicate higher intensities of pain.
Opioid Analgesic Usage
Time frame: 1 day post-operatively
The amount of post-operative opioid analgesic usage is assessed as Oral Morphine Equivalents (OME) which is the amount of an oral morphine drug that would be necessary to equal the pain treatment from opioid morphine.
10 secondary outcomes
Soft Tissue Swelling
Time frame: 1 day post-operatively
Range of Motion (ROM)
Time frame: Baseline, 1 day post-operatively, 1, 4, and 12 months post-operatively
Post-operative Day of Physical Therapy Clearance
Time frame: Up to 3 days post-operatively
Antiemetic Dose Administered
Time frame: Post-operative Days 1 and 2
Blood Glucose
Time frame: Baseline, Post-operative Day 1
36-Item Short Form Health Survey (SF-36) Score
Time frame: Baseline, 12 months post-operatively
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score
Time frame: Baseline, 1, 4, and 12 months post-operatively
Length of Hospital Stay
Time frame: Up to 3 days post-operatively
Number of Participants Readmitted to the Hospital
Time frame: Up to 12 months post-operatively
Number of Participants With Wound Infections
Time frame: Up to 12 months post-operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Thomas L Bradbury, MD principal investigator
Emory University
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 10 mg, Dexamethasone 20 mg and Standard multimodal pain management regimen in people with Postoperative Pain and Inflammation, run by Thomas L Bradbury at 1 site in United States.
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 15 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: stopped early, as of the sponsor's last update on 4 Oct 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 4 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Score (time frame: Baseline, end of hospital stay (up to 3 days), 1, 4, and 12 months post-operatively). The study lists 2 primary outcomes in all. 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 4 Oct 2022.