Postoperative Pain, AcuteNCT05861791
Comparison of Patient-controlled Analgesia Regimenfor Postoperative Pain in Patients Undergoing Total Knee Arthroplasty
A study testing Fentanyl and ketorolac tromethamine with nefopam hydrochloride in people with Postoperative Pain, Acute, run by Chung-Ang University Gwangmyeong Hospital at 1 site in South Korea.
Trial summary
Patients who undergoing total knee arthroplasty under spinal analgesia will be recruited and randomly assigned to the following two groups according to the regimen of PCA: (A) opioid group who receive only fentanyl citrate 1200mcg for continuous infusion drug, (B) non-opioid group who receive ketorolac tromethamine… Read more about this study
- Who is it for?
- Ages 60 to 79 years
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- Fentanyl and ketorolac tromethamine with nefopam hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Feb 2023to 12 Jul 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 60 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-II
- undergoing elective total knee arthroplasty under spinal anesthesia
Who cannot join
- history of stomack ulceration
- increased ICP
- bronchial asthma
- allergy on aspirin, NSAIDs, Nefopam
- drug user of antiplatelet or anticoagulant
Trial locations and contacts
1 site in 1 country.
South Korea1 site
ChungAng University Gwangmyeong Hospital
Gyeonggi-do, Gwangmyeon-si, 14353
About this study
Official title: Comparison of Patient-controlled Analgesia With Background Opioid Versus Non-opioid Infusion for Postoperative Pain in Patients Undergoing Total Knee Arthroplasty: a Randomized, Non-inferiority Study
Patients who undergoing total knee arthroplasty under spinal analgesia will be recruited and randomly assigned to the following two groups according to the regimen of PCA: (A) opioid group who receive only fentanyl citrate 1200mcg for continuous infusion drug, (B) non-opioid group who receive ketorolac tromethamine 150mg with nefopam hydrochloride 100mg for continuous infusion drug. All the patients will receive additional fentanyl citrate as bolus injection drug if they need more analgesics postoperatively.
- Conditions
- Postoperative Pain, Acute
- Being tested
- Fentanyl, ketorolac tromethamine with nefopam hydrochloride
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called opioid group
opioid group receives only fentanyl citrate 1200mcg for continuous infusion drug
ketorolac tromethamine with nefopam hydrochlorideDrug
non-opioid group receives ketorolac tromethamine 150mg with nefopam hydrochloride 100mg for continuous infusion drug
| Study group | Role | What they receive |
|---|---|---|
| opioid group | Experimental | IV-PCA consisted of fentanyl Receives: Drug: Fentanyl |
| non-opioid group | Active comparator | IV-PCA consisted of ketorolac and nefopam Receives: Drug: ketorolac tromethamine with nefopam hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain score
evaluated by visual analogue scale
Measured: 24 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start7 Feb 2023
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University Gwangmyeong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Se-Hee Min, Chung-Ang University Gwangmyeong Hospital
- Investigators
- Se-Hee Min, Principal investigator, ChungAng University Gwangmyeon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861791
- Sponsor's protocol ID
- 2210033049
- Status last verified
- Jul 2024
- First submitted
- 8 Feb 2023
- Last updated
- 15 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patient-controlled Analgesia With Background Opioid Versus Non-opioid Infusion for Postoperative Pain in Patients Undergoing Total Knee Arthroplasty: a Randomized, Non-inferiority Study
- ClinicalTrials.gov ID
- NCT05861791
- Acronym / sponsor ID
- 2210033049
- Conditions
- Postoperative Pain, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Chung-Ang University Gwangmyeong HospitalUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 17 May 2023 (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.
Patients who undergoing total knee arthroplasty under spinal analgesia will be recruited and randomly assigned to the following two groups according to the regimen of PCA: (A) opioid group who receive only fentanyl citrate 1200mcg for continuous infusion drug, (B) non-opioid group who receive ketorolac tromethamine 150mg with nefopam hydrochloride 100mg for continuous infusion drug. All the patients will receive additional fentanyl citrate as bolus injection drug if they need more analgesics postoperatively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| opioid group | Experimental | Drug: FentanylIV-PCA consisted of fentanyl |
| non-opioid group | Active comparator | Drug: ketorolac tromethamine with nefopam hydrochlorideIV-PCA consisted of ketorolac and nefopam |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA physical status I-II
- undergoing elective total knee arthroplasty under spinal anesthesia
Key exclusion criteria (5 listed)
- history of stomack ulceration
- increased ICP
- bronchial asthma
- allergy on aspirin, NSAIDs, Nefopam
- drug user of antiplatelet or anticoagulant
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 |
|---|---|---|
| FentanylAlso: opioid groupopioid group receives only fentanyl citrate 1200mcg for continuous infusion drug | Drug | opioid group |
| ketorolac tromethamine with nefopam hydrochloridenon-opioid group receives ketorolac tromethamine 150mg with nefopam hydrochloride 100mg for continuous infusion drug | Drug | non-opioid group |
Primary outcome
postoperative pain score
Time frame: 24 hours after the surgery
evaluated by visual analogue scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
Related trials for Postoperative Pain, Acute
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
Recruiting
Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Analgesia in Arthroscopic Shoulder Surgery
Postoperative Pain, Acute, Shoulder Pain
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
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.
Se-Hee Min principal investigator
ChungAng University Gwangmyeon 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 Fentanyl and ketorolac tromethamine with nefopam hydrochloride in people with Postoperative Pain, Acute, run by Chung-Ang University Gwangmyeong Hospital at 1 site in South Korea.
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 2 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: finished, as of the sponsor's last update on 15 Jul 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 South Korea. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
postoperative pain score (time frame: 24 hours after the surgery). 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 15 Jul 2024.