Osteoarthritis of the KneePhase 4NCT02760459
Effects of Perioperative Intravenous Dexamethasone on the Severity of Persistent Postsurgical Pain After Total Knee Arthroplasty : A Prospective, Randomized, Double-blind, Placebo-controlled Trial
A Phase 4 study testing Dexamethasone and Normal saline solution in people with Osteoarthritis of the Knee, run by Chiang Mai University at 1 site in Thailand.
Trial summary
To compare the effects of perioperative intravenous Dexamethasone with a placebo on the severity of persistent postsurgical pain after total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Dexamethasone and Normal saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2016to Jun 2017
- 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 (45)
- Primary knee osteoarthritis diagnosed using the American College of Rheumatology criteria (46)
- Undergoing elective, primary and unilateral total knee arthroplasty
- American Society of Anesthesiology (ASA) physical status class 1-3
- BMI < 40 kg/m2
Who cannot join
- History of active rheumatic diseases
- History of previous musculoskeletal injury of the same knee for excluding patients with secondary knee osteoarthritis
- History of previous surgery on the same knee
- History of adverse effects from medications to be used in this study
- Contraindication to spinal anesthesia
- History of psychiatric disorders or cognitive impairment
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- Contraindication to corticosteroid agents
- Poorly controlled diabetes mellitus (HbA1C > 7.5)
- Poorly controlled hypertension
- History of ischemic heart disease or peripheral arterial disease or cerebrovascular disease
- Hepatic insufficiency (Child-Pugh score > 5)
- Renal insufficiency (Creatinine clearance < 30 mL/min)
- History of cataracts or glaucoma or ocular hypertension
- History of steroid or immunosuppressive drug use within 6 months of surgery
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Department of Orthopedics, Chiang Mai University
Chiang Mai, ChiangMai, 50200
Nitchanant Kitchatanant, +66871071133, nk_win@hotmail.com
About this study
To compare the effects of perioperative intravenous Dexamethasone with a placebo on the severity of persistent postsurgical pain after total knee arthroplasty.
Read the detailed description
It is not clear whether perioperative intravenous Dexamethasone has an effect on severity of persistent postsurgical pain (PPSP) after total knee arthroplasty (TKA). The research hypothesis is that TKA patients experience less severe PPSP after administration of perioperative intravenous Dexamethasone.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Dexamethasone, Normal saline solution
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Normal saline solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | The steroid group will receive Dexamethasone 10 mg IV immediately prior to induction of spinal anesthesia and will receive a second and third dose of Dexamethasone 10 mg IV postoperatively at 24 and 48 hrs. Receives: Drug: Dexamethasone |
| Placebo | Placebo comparator | The control group will receive sterile normal saline solution, serving as placebo, IV immediately prior to induction of spinal anesthesia and will receive a second and third dose of placebo IV postoperatively 24 and 48 hrs. Both Dexamethasone and normal saline solution will be administered as an IV push. Receives: Drug: Normal saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified WOMAC scores for pain at 12 weeks postoperative
using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire
Measured: 12 weeks
Secondary outcomes (10)
Visual analogue scales for pain during a five-meter walk (0-100)
Measured: postoperatively at 24, 30, 48, 54, 72 hrs
Visual analogue scales for pain during 45 degree active knee flexion (0-100)
Measured: postoperatively at 6, 24, 30, 48, 54, 72 hrs
Visual analogue scales for current pain at rest in a supine position (0-100)
Measured: postoperatively at 6, 24, 30, 48, 54, 72 hrs
Visual analogue scales for maximum pain at rest over the last 24 hours and minimum pain at rest over the last 24 hours (0-100)
Measured: postoperatively at 0-24, 24-48, 48-72 hrs
Visual analogue scale values for nausea (0-100)
Measured: postoperatively at 6, 24, 30, 48, 54, 72 hrs
Opioid consumption (mg.)
Measured: during the first 0-24, 24-48, and 48-72 hrs
Anti-emetic medicine consumption (mg.)
Measured: during the first 0-24, 24-48, and 48-72 hrs
Maximum degree of active knee flexion
Measured: postoperatively at 24, 48, 72 hrs, 2 weeks, 6 weeks, and 12 weeks
Modified WOMAC scores for pain
using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire
Measured: postoperatively at weeks 2 and 6
Wound complications
Measured: evaluated postoperatively at weeks 2, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the KneeStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nitchanant Kitcharanant, Chiang Mai University
- Investigators
- Nitchanant Kitcharanant, MD, Principal investigator, Department of Orthopedics, Faculty of Medicine, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760459
- Sponsor's protocol ID
- ORT-2558-03245
- Other IDs
- 054/2559
- Status last verified
- Oct 2016
- First submitted
- 1 May 2016
- Last updated
- 10 Oct 2016
- Results posted
- No
Publications
1. Callahan CM, Drake BG, Heck DA, Dittus RS. Patient outcomes following tricompartmental total knee replacement. A meta-analysis. JAMA. 1994;271(17):1349-57. 2. Grosu I, Lavand'homme P, Thienpont E. Pain after knee arthroplasty: an unresolved issue. Knee Surg Sports Traumatol Arthrosc. 2014;22(8):1744-58.
Kitcharanant N, Leurcharusmee P, Atthakomol P, Jingjit W. Perioperative intravenous dexamethasone did not reduce the severity of persistent postsurgical pain after total knee arthroplasty: a prospective, randomized, double-blind, placebo-controlled trial. J Orthop Surg Res. 2024 Dec 19;19(1):854. doi: 10.1186/s13018-024-05362-y.
PubMed 39702151
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Perioperative Intravenous Dexamethasone on the Severity of Persistent Postsurgical Pain After Total Knee Arthroplasty : A Prospective, Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02760459
- Acronym / sponsor ID
- ORT-2558-03245
- Conditions
- Osteoarthritis of the Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jun 2017 (estimated)
- First posted
- 3 May 2016 (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.
To compare the effects of perioperative intravenous Dexamethasone with a placebo on the severity of persistent postsurgical pain after total knee arthroplasty.
Detailed description
It is not clear whether perioperative intravenous Dexamethasone has an effect on severity of persistent postsurgical pain (PPSP) after total knee arthroplasty (TKA). The research hypothesis is that TKA patients experience less severe PPSP after administration of perioperative intravenous Dexamethasone.
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 |
|---|---|---|
| Dexamethasone | Active comparator | Drug: DexamethasoneThe steroid group will receive Dexamethasone 10 mg IV immediately prior to induction of spinal anesthesia and will receive a second and third dose of Dexamethasone 10 mg IV postoperatively at 24 and 48 hrs. |
| Placebo | Placebo comparator | Drug: Normal saline solutionThe control group will receive sterile normal saline solution, serving as placebo, IV immediately prior to induction of spinal anesthesia and will receive a second and third dose of placebo IV postoperatively 24 and 48 hrs. Both Dexamethasone and normal saline solution will be administered as an IV push. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 40 years (45)
- Primary knee osteoarthritis diagnosed using the American College of Rheumatology criteria (46)
- Undergoing elective, primary and unilateral total knee arthroplasty
- American Society of Anesthesiology (ASA) physical status class 1-3
- BMI < 40 kg/m2
Key exclusion criteria (14 listed)
- History of active rheumatic diseases
- History of previous musculoskeletal injury of the same knee for excluding patients with secondary knee osteoarthritis
- History of previous surgery on the same knee
- History of adverse effects from medications to be used in this study
- Contraindication to spinal anesthesia
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 | Drug | Dexamethasone |
| Normal saline solution | Drug | Placebo |
Primary outcome
Modified WOMAC scores for pain at 12 weeks postoperative
Time frame: 12 weeks
using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire
10 secondary outcomes
Visual analogue scales for pain during a five-meter walk (0-100)
Time frame: postoperatively at 24, 30, 48, 54, 72 hrs
Visual analogue scales for pain during 45 degree active knee flexion (0-100)
Time frame: postoperatively at 6, 24, 30, 48, 54, 72 hrs
Visual analogue scales for current pain at rest in a supine position (0-100)
Time frame: postoperatively at 6, 24, 30, 48, 54, 72 hrs
Visual analogue scales for maximum pain at rest over the last 24 hours and minimum pain at rest over the last 24 hours (0-100)
Time frame: postoperatively at 0-24, 24-48, 48-72 hrs
Visual analogue scale values for nausea (0-100)
Time frame: postoperatively at 6, 24, 30, 48, 54, 72 hrs
Opioid consumption (mg.)
Time frame: during the first 0-24, 24-48, and 48-72 hrs
Anti-emetic medicine consumption (mg.)
Time frame: during the first 0-24, 24-48, and 48-72 hrs
Maximum degree of active knee flexion
Time frame: postoperatively at 24, 48, 72 hrs, 2 weeks, 6 weeks, and 12 weeks
Modified WOMAC scores for pain
Time frame: postoperatively at weeks 2 and 6
Wound complications
Time frame: evaluated postoperatively at weeks 2, 6 and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2016.
- Background1. Callahan CM, Drake BG, Heck DA, Dittus RS. Patient outcomes following tricompartmental total knee replacement. A meta-analysis. JAMA. 1994;271(17):1349-57. 2. Grosu I, Lavand'homme P, Thienpont E. Pain after knee arthroplasty: an unresolved issue. Knee Surg Sports Traumatol Arthrosc. 2014;22(8):1744-58.
- Derived from this study: PubMed 39702151Kitcharanant N, Leurcharusmee P, Atthakomol P, Jingjit W. Perioperative intravenous dexamethasone did not reduce the severity of persistent postsurgical pain after total knee arthroplasty: a prospective, randomized, double-blind, placebo-controlled trial. J Orthop Surg Res. 2024 Dec 19;19(1):854. doi: 10.1186/s13018-024-05362-y.
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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.
Nitchanant Kitcharanant, MD principal investigator
Department of Orthopedics, Faculty of Medicine, Chiang Mai 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 and Normal saline solution in people with Osteoarthritis of the Knee, run by Chiang Mai University at 1 site in Thailand.
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 5 inclusion and 14 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 10 Oct 2016. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nitchanant Kitcharanant, MD (+66871071133, nk_win@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified WOMAC scores for pain at 12 weeks postoperative (time frame: 12 weeks). 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 NCT02760459, which also lists 2 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 10 Oct 2016.