Localized Primary Osteoarthritis of Both Hips (Diagnosis)Phase 4NCT03542617
Effect of Preoperative Intravenous Dexamethasone on Postoperative Pain After Primary Total Hip Arthroplasty
A Phase 4 study testing Dexamethasone and Normal Saline Solution in people with Localized Primary Osteoarthritis of Both Hips (Diagnosis) and Osteoarthritis, Hip, run by Chiang Mai University at 1 site in Thailand.
Trial summary
To compare the effects of preoperative intravenous Dexamethasone between 10 mg and 40 mg with placebo on Postoperative Pain After Primary Total Hip Arthroplasty Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Localized Primary Osteoarthritis of Both Hips (Diagnosis), Osteoarthritis, Hip
- 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
- 57 participants
- Where
- 1 siteThailand
- Study dates
- 5 Oct 2016to 31 Dec 2020
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Undergoing Elective, Primary, unilateral Total Hip arthroplasty
- American Society of Anesthesiology (ASA) physical class 1-3
- BMI < 40 kg/m2
Who cannot join
- History of previous musculoskeletal injury on the same hip
- History of prior surgery on the same unilateral hip
- History of adverse effects from medication utilized in this study
- Contraindication to spinal anesthesia
- History of psychiatric disorders or cognitive impairment
- Contraindication to Corticosteroid
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- Poorly controlled Diabetes mellitus
- 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 cataract or glaucoma or ocular hypertension
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Department of Orthopedics, Chiang Mai University
Chiang Mai, 50200
Nitchanant Kitcharanant, +66871071133, nk_win@hotmail.com
About this study
Official title: Effect of Preoperative Intravenous Dexamethasone on Postoperative Pain After Primary Total Hip Arthroplasty : A Prospective, Double-blind, Randomized Controlled Trial
To compare the effects of preoperative intravenous Dexamethasone between 10 mg and 40 mg with placebo on Postoperative Pain After Primary Total Hip Arthroplasty
Read the detailed description
It still unclear whether the effective dose preoperative intravenous dexamethasone on postoperative pain after Total Hip Arthroplasty. The research hypothesis is that the effect of 10 mg intravenous Dexamethasone in postoperative pain(5 metre walking at 24 hour) is not inferior to 40 mg intravenous Dexamethasone
- Being tested
- Dexamethasone, Normal Saline Solution
- Medical subject headings
- Disease, Osteoarthritis, Hip
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 |
|---|---|---|
| Normal Saline Solution | Placebo comparator | The control group receive sterile normal saline solution, as placebo, intravenous immediately prior to induction of spinal anesthesia . Receives: Drug: Normal Saline Solution |
| 10 mg Dexamethasone | Active comparator | The steroid group will receive Dexamethasone 10 mg IV immediately prior to induction of spinal anesthesia Receives: Drug: Dexamethasone |
| 40 mg Dexamethasone | Active comparator | The steroid group will receive Dexamethasone 40 mg IV immediately prior to induction of spinal anesthesia Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scales for pain during five-metre walking (0-100)
Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain;
Measured: at 24 hours postoperatively
Secondary outcomes (8)
Visual analogue scales for pain during five-metre walking (0-100)
Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain;
Measured: Postoperative at 48,72 hours.
Visual analogue scales for pain on 45 degree active hip flexion (0-100)
Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain;
Measured: Postoperative at 24,48,72 hours.
Visual analogue scales for current pain at rest on supine position (0-100)
Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain;
Measured: Postoperative at 6,24,48,72 hours.
Visual analogue scales for the maximal pain at rest over the last 24 hours and the minimal pain at rest over the last 24 hours (0-100)
Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain;
Measured: Postoperative at 0-24,24-48,48-72 hours.
Visual analogue scales for nausea (0-100)
This outcome will be assessed in a form of visual analogue scale of 0-100 mm, in which 0 indicates no nausea or vomiting and 100 indicates the worst nausea or vomiting
Measured: Postoperative at 6,24,48,72 hours
Opioid consumption (mg.)
Opioid consumption (mg.)
Measured: Postoperative at 0-24,24-48,48-72 hours
Anti-emetic medicine consumption (mg.)
Anti-emetic medicine consumption (mg.)
Measured: Postoperative at 0-24,24-48,48-72 hours
Wound complication
Wound complications (including periprosthetic joint infection and inadequate wound healing). Periprosthetic joint infection will be diagnosed using the criteria outlined by the Musculoskeletal Infection Society. Inadequate wound healing is defined as delayed wound healing or wound dehiscence
Measured: Postoperative at Discharge, 2 weeks, 6 weeks, 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start5 Oct 2016
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Primary Osteoarthritis of Both Hips (Diagnosis)Studies 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
- 57 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542617
- Sponsor's protocol ID
- ORT-2559-03928
- Status last verified
- May 2018
- First submitted
- 20 May 2018
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Intravenous Dexamethasone on Postoperative Pain After Primary Total Hip Arthroplasty : A Prospective, Double-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03542617
- Acronym / sponsor ID
- ORT-2559-03928
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 5 Oct 2016 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 31 May 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.
To compare the effects of preoperative intravenous Dexamethasone between 10 mg and 40 mg with placebo on Postoperative Pain After Primary Total Hip Arthroplasty
Detailed description
It still unclear whether the effective dose preoperative intravenous dexamethasone on postoperative pain after Total Hip Arthroplasty. The research hypothesis is that the effect of 10 mg intravenous Dexamethasone in postoperative pain(5 metre walking at 24 hour) is not inferior to 40 mg 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Saline Solution | Placebo comparator | Drug: Normal Saline SolutionThe control group receive sterile normal saline solution, as placebo, intravenous immediately prior to induction of spinal anesthesia . |
| 10 mg Dexamethasone | Active comparator | Drug: DexamethasoneThe steroid group will receive Dexamethasone 10 mg IV immediately prior to induction of spinal anesthesia |
| 40 mg Dexamethasone | Active comparator | Drug: DexamethasoneThe steroid group will receive Dexamethasone 40 mg IV immediately prior to induction of spinal anesthesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Undergoing Elective, Primary, unilateral Total Hip arthroplasty
- American Society of Anesthesiology (ASA) physical class 1-3
- BMI < 40 kg/m2
Key exclusion criteria (11 listed)
- History of previous musculoskeletal injury on the same hip
- History of prior surgery on the same unilateral hip
- History of adverse effects from medication utilized in this study
- Contraindication to spinal anesthesia
- History of psychiatric disorders or cognitive impairment
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 | 10 mg Dexamethasone, 40 mg Dexamethasone |
| Normal Saline Solution | Drug | Normal Saline Solution |
Primary outcome
Visual analogue scales for pain during five-metre walking (0-100)
Time frame: at 24 hours postoperatively
Each pain outcome will be assessed using a visual analogue scale of 0-100 mm, in which 0 indicates no pain and 100 indicates the worst pain;
8 secondary outcomes
Visual analogue scales for pain during five-metre walking (0-100)
Time frame: Postoperative at 48,72 hours.
Visual analogue scales for pain on 45 degree active hip flexion (0-100)
Time frame: Postoperative at 24,48,72 hours.
Visual analogue scales for current pain at rest on supine position (0-100)
Time frame: Postoperative at 6,24,48,72 hours.
Visual analogue scales for the maximal pain at rest over the last 24 hours and the minimal pain at rest over the last 24 hours (0-100)
Time frame: Postoperative at 0-24,24-48,48-72 hours.
Visual analogue scales for nausea (0-100)
Time frame: Postoperative at 6,24,48,72 hours
Opioid consumption (mg.)
Time frame: Postoperative at 0-24,24-48,48-72 hours
Anti-emetic medicine consumption (mg.)
Time frame: Postoperative at 0-24,24-48,48-72 hours
Wound complication
Time frame: Postoperative at Discharge, 2 weeks, 6 weeks, 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
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.
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 Localized Primary Osteoarthritis of Both Hips (Diagnosis) and Osteoarthritis, Hip, 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 4 inclusion and 11 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 1 Jun 2018. 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 Vutinan Manassoontornvuti, MD (+66909712741, m.vutinan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scales for pain during five-metre walking (0-100) (time frame: at 24 hours postoperatively). 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 1 Jun 2018.