Postoperative PainNCT06300008
Cetylated Fatty Acid for Reducing Pain After TKA
A study testing cetylated fatty acid in people with Postoperative Pain and Postoperative Inflammation, run by Thammasat University at 1 site in Thailand.
Trial summary
To compare efficacy of cetylated fatty acid with placebo for reducing postoperative pain after unilateral TKA. The hypothesis is topical cetylated fatty acid can mitigate postoperative pain after TKA. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Postoperative Pain, Postoperative Inflammation
- What is being tested?
- cetylated fatty acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 12 Feb 2024to Dec 2024
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50-80 years
- Osteoarthritic knee patients underwent unilateral primary TKA
- Participants understand and consent to the protocol of the trial
Who cannot join
- Inflammatory knee arthritis
- Previous knee surgery or trauma
- Previous knee infection
- Skin problem around the knee such as eczema, psoriasis, wound infection
- Allergy to studied drug
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
department of orthopaedic surgery, Faculty of medicine, Thammasat university
Khlong Luang, Changwat Pathum Thani, 066
supakit kanitnate, 6629260000, naypeng@hotmail.com
Nattapol Tammachote, M.D.
About this study
Official title: Efficacy of Cetylated Fatty Acid for Alleviating Postoperative Pain After Total Knee Arthroplasty: A Randomized Placebo-controlled Trial
To compare efficacy of cetylated fatty acid with placebo for reducing postoperative pain after unilateral TKA. The hypothesis is topical cetylated fatty acid can mitigate postoperative pain after TKA.
- Conditions
- Postoperative Pain, Postoperative Inflammation
- Being tested
- cetylated fatty acid, Placebo
- Keywords
- Cetylated fatty acid, TKA, Postoperative pain, Inflammation
- Medical subject headings
- Pain, Postoperative, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetylated fatty acidDrug
Also called Cetilar
use approximately 3 cm long of cream per each side of knee, then apply on the operated knee until completely absorb
PlaceboDrug
use approximately 3 cm long of cream per each side of knee, then apply on the operated knee until completely absorb
| Study group | Role | What they receive |
|---|---|---|
| cetylated fatty acid | Experimental | Topical cetylated fatty acid, apply 2 times/day for 6 weeks after operation Receives: Drug: cetylated fatty acid |
| Placebo | Placebo comparator | Topical placebo, apply 2 times/day for 6 weeks after operation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
VAS (0-100) at rest and on motion
Measured: post-op Day2
Visual analog scale
VAS (0-100) at rest and on motion
Measured: post-op week2
Visual analog scale
VAS (0-100) at rest and on motion
Measured: post-op week6
Visual analog scale
VAS (0-100) at rest and on motion
Measured: post-op week12
inflammatory marker
ESR and CRP
Measured: post-op day2
inflammatory marker
ESR and CRP
Measured: post-op week2
inflammatory marker
ESR and CRP
Measured: post-op week6
inflammatory marker
ESR and CRP
Measured: post-op week12
Knee skin temperature
evaluated by digital infrared thermometer at 4 different locations on the anterior aspect of the knee independently (superomedial, superolateral, inferomedial, inferolateral borders of the patella) compared with the contralateral knee
Measured: post-op Day2
Knee skin temperature
evaluated by digital infrared thermometer at 4 different locations on the anterior aspect of the knee independently (superomedial, superolateral, inferomedial, inferolateral borders of the patella) compared with the contralateral knee
Measured: post-op week2
Knee skin temperature
evaluated by digital infrared thermometer at 4 different locations on the anterior aspect of the knee independently (superomedial, superolateral, inferomedial, inferolateral borders of the patella) compared with the contralateral knee
Measured: post-op week6
Knee skin temperature
evaluated by digital infrared thermometer at 4 different locations on the anterior aspect of the knee independently (superomedial, superolateral, inferomedial, inferolateral borders of the patella) compared with the contralateral knee
Measured: post-op week12
Secondary outcomes (14)
Knee circumference (cm)
Measured by tape at midpoint of patella
Measured: post-op Day2
Knee circumference (cm)
Measured by tape at midpoint of patella
Measured: post-op week2
Knee circumference (cm)
Measured by tape at midpoint of patella
Measured: post-op week6
Knee circumference (cm)
Measured by tape at midpoint of patella
Measured: post-op week12
Knee Range of Motion
Flexion and extension angle
Measured: post-op Day2
Knee Range of Motion
Flexion and extension angle
Measured: post-op week2
Knee Range of Motion
Flexion and extension angle
Measured: post-op week6
Knee Range of Motion
Flexion and extension angle
Measured: post-op week12
Modified WOMAC
Total \& Subscore
Measured: post-op week2
Modified WOMAC
Total \& Subscore
Measured: post-op week6
Modified WOMAC
Total \& Subscore
Measured: post-op week12
Thai forgotten joint score
Measured: post-op week2
Thai forgotten joint score
Measured: post-op week6
Thai forgotten joint score
Measured: post-op week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start12 Feb 2024
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Supakit Kanitnate, Thammasat University
- Investigators
- Supakit Kanitnate, MD, Principal investigator, Thammasat University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300008
- Sponsor's protocol ID
- OrthoTU13
- Status last verified
- Mar 2024
- First submitted
- 24 Nov 2022
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cetylated Fatty Acid for Alleviating Postoperative Pain After Total Knee Arthroplasty: A Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06300008
- Acronym / sponsor ID
- OrthoTU13
- Conditions
- Postoperative Pain, Postoperative Inflammation
- Keywords
- Cetylated fatty acid, TKA, Postoperative pain, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Mar 2024 (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 efficacy of cetylated fatty acid with placebo for reducing postoperative pain after unilateral TKA. The hypothesis is topical cetylated fatty acid can mitigate postoperative pain after TKA.
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 |
|---|---|---|
| cetylated fatty acid | Experimental | Drug: cetylated fatty acidTopical cetylated fatty acid, apply 2 times/day for 6 weeks after operation |
| Placebo | Placebo comparator | Drug: PlaceboTopical placebo, apply 2 times/day for 6 weeks after operation |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50-80 years
- Osteoarthritic knee patients underwent unilateral primary TKA
- Participants understand and consent to the protocol of the trial
Key exclusion criteria (5 listed)
- Inflammatory knee arthritis
- Previous knee surgery or trauma
- Previous knee infection
- Skin problem around the knee such as eczema, psoriasis, wound infection
- Allergy to studied drug
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 |
|---|---|---|
| cetylated fatty acidAlso: Cetilaruse approximately 3 cm long of cream per each side of knee, then apply on the operated knee until completely absorb | Drug | cetylated fatty acid |
| Placebouse approximately 3 cm long of cream per each side of knee, then apply on the operated knee until completely absorb | Drug | Placebo |
Primary outcome
Visual analog scale
Time frame: post-op Day2
VAS (0-100) at rest and on motion
Visual analog scale
Time frame: post-op week2
VAS (0-100) at rest and on motion
Visual analog scale
Time frame: post-op week6
VAS (0-100) at rest and on motion
Visual analog scale
Time frame: post-op week12
VAS (0-100) at rest and on motion
inflammatory marker
Time frame: post-op day2
ESR and CRP
inflammatory marker
Time frame: post-op week2
ESR and CRP
inflammatory marker
Time frame: post-op week6
ESR and CRP
inflammatory marker
Time frame: post-op week12
ESR and CRP
Knee skin temperature
Time frame: post-op Day2
evaluated by digital infrared thermometer at 4 different locations on the anterior aspect of the knee independently (superomedial, superolateral, inferomedial, inferolateral borders of the patella) compared with the contralateral knee
Knee skin temperature
Time frame: post-op week2
evaluated by digital infrared thermometer at 4 different locations on the anterior aspect of the knee independently (superomedial, superolateral, inferomedial, inferolateral borders of the patella) compared with the contralateral knee
Knee skin temperature
Time frame: post-op week6
evaluated by digital infrared thermometer at 4 different locations on the anterior aspect of the knee independently (superomedial, superolateral, inferomedial, inferolateral borders of the patella) compared with the contralateral knee
Knee skin temperature
Time frame: post-op week12
evaluated by digital infrared thermometer at 4 different locations on the anterior aspect of the knee independently (superomedial, superolateral, inferomedial, inferolateral borders of the patella) compared with the contralateral knee
14 secondary outcomes
Knee circumference (cm)
Time frame: post-op Day2
Knee circumference (cm)
Time frame: post-op week2
Knee circumference (cm)
Time frame: post-op week6
Knee circumference (cm)
Time frame: post-op week12
Knee Range of Motion
Time frame: post-op Day2
Knee Range of Motion
Time frame: post-op week2
Knee Range of Motion
Time frame: post-op week6
Knee Range of Motion
Time frame: post-op week12
Modified WOMAC
Time frame: post-op week2
Modified WOMAC
Time frame: post-op week6
Modified WOMAC
Time frame: post-op week12
Thai forgotten joint score
Time frame: post-op week2
Thai forgotten joint score
Time frame: post-op week6
Thai forgotten joint score
Time frame: post-op week12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- 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.
Supakit Kanitnate, MD principal investigator
Thammasat University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cetylated fatty acid in people with Postoperative Pain and Postoperative Inflammation, run by Thammasat 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 3 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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. 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.
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 Supakit Kanitnate, M.D. (66899853635, naypeng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: post-op Day2). The study lists 12 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 8 Mar 2024.