Postoperative PainPhase 2NCT05324995
Peri-Articular-Multimodal Drug and Oral Celecoxib in Management of Postoperative Pain of Total Knee Arthroplasty
A Phase 2 study testing Multimodal Drug, epinephrine and celecoxib in people with Postoperative Pain and Total Knee Arthroplasty, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
This study is a randomized-clinical-trial on 146 patients candidate for total knee arthroplasty (TKA) who were randomly allocated to three treatment groups, including 1) a cocktail consisting of bupivacaine, morphine, epinephrine, and ketorolac (n=48), 2) only epinephrine (placebo group) (n=49), and 3) 400mg celecoxib… Read more about this study
- Who is it for?
- Ages 37 to 81 years
- Conditions the study is for
- Postoperative Pain, Total Knee Arthroplasty
- What is being tested?
- Multimodal Drug, epinephrine and celecoxib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2021to 1 Mar 2022
- Phase
- Phase 2
- 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 37 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of osteoarthritis
- Candidate for primary unilateral TKA
- Body mass index of 20-30 kg/m2
Who cannot join
- Unable to follow-up the assessments
- Having more than 20% defects in medical records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Pre-emptive Injection of Peri-Articular-Multimodal Drug With Oral Celecoxib for Postoperative Pain Management in Total Knee Arthroplasty: A Randomized Clinical Trial
This study is a randomized-clinical-trial on 146 patients candidate for total knee arthroplasty (TKA) who were randomly allocated to three treatment groups, including 1) a cocktail consisting of bupivacaine, morphine, epinephrine, and ketorolac (n=48), 2) only epinephrine (placebo group) (n=49), and 3) 400mg celecoxib orally (control group) (n=49) using Random Allocation software. The injections and oral therapy were performed within 15 minutes before the surgical procedure. The study's primary outcome was the Knee Society Score (KSS) calculated at baseline, within six weeks and six months postoperatively. Range of motion (ROM) and Visual Analogue Scale (VAS) to assess pain intensity as the other primary outcomes were evaluated before the procedure, within 24 hours, 48 hours, and six weeks postoperatively.
Read the detailed description
This randomized clinical trial conducted on 146 patients undergone TKA in orthopedic hospitals affiliated at Isfahan University of Medical Science (IUMS) in 2021.
The presence of osteoarthritis, making the patients candidate for primary unilateral total knee arthroplasty (TKA), and body mass index of 20-30 kg/m2 were determined as inclusion criteria.
The Regional Bioethics Committee of IUMS approved the study protocol. This study was designed as a census study; therefore, all the patients who met the criteria for participation in this study were recruited. Participants were randomly divided into three groups using Random Allocation software, so each patient was provided with a specific number from 1-to-146 by the software and allocated to one of the groups.
The investigator who performed the baseline and follow-up assessments and the patients were unaware of the study group; as the investigator was absent at the time of the surgery and all the patients administered a pill prior to the surgical procedure (one group was treated with celecoxib and the other two ones administered placebo similar in shape and color with celecoxib).
The primary outcome was the Knee Society Score (KSS) calculated at baseline, within six weeks and six months postoperatively. Range of motion (ROM) and Visual Analogue Scale (VAS) to assess pain intensity as the other primary outcomes were evaluated before the procedure, within 24 hours, 48 hours, and six weeks postoperatively.
- Conditions
- Postoperative Pain, Total Knee Arthroplasty
- Being tested
- Multimodal Drug, epinephrine, celecoxib
- Keywords
- Total knee arthroplasty, Pain, Multimodal analgesia, Range of motion
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal DrugDrug
Also called Case
The Multimodal Drug group received morphine, epinephrine, and ketorolac (n=48), The epinephrine group (placebo group) (n=49) received 300 mcg epinephrine (1:1000) (DarouPakhsh, Tehran, Iran) peri-articulary,and the celecoxib group(control group)(n=49) recieved 400mg celecoxib orally
epinephrineDrug
Also called Placebo
The second group received 300 mcg epinephrine (1:1000) (DarouPakhsh, Tehran, Iran) peri-articulary
celecoxibDrug
Also called Control
The third group administered celecoxib (200 mg) orally immediately before the surgery
| Study group | Role | What they receive |
|---|---|---|
| Multimodal injection | Experimental | The first group was treated using a preemptive periarticular injection of multimodal drugs. Therefore, a combination of drugs consisted of 50 mg bupivacaine hydrochloride 0.5% (AstraZeneca, Cenexi, France), 1 ml morphine sulfate 10 mg/ml (DarouPakhsh, Tehran, Iran), 300 mcg epinephrine (1:1000) (DarouPakhsh, Tehran, Iran) and 30 mg ketorolac (Caspian Tamin, Rasht, Iran) diluted by 0.9% sodium chloride solution to make a total 100 ml of injection drug was injected in periarticular area. The injections were done within 15 minutes before the incision in seven areas of the joint as followed: 15 ml in posterolateral soft tissue and lateral femoral periosteum, 15 ml posteromedial soft tissue and medial femoral periosteum, 20 ml inferomedial capsule, 20 ml superomedial capsule, 10 ml lateral capsule, 10 ml medial subcutaneous tissues and 10 ml lateral subcutaneous tissue. Receives: Drug: Multimodal Drug |
| epinephrine group (placebo group) | Experimental | The second group received 300 mcg epinephrine (1:1000) (DarouPakhsh, Tehran, Iran) peri-articulary, similar to the first group. Receives: Drug: epinephrine |
| celecoxib group (control group) | Experimental | The third group administered celecoxib (200 mg) orally immediately before the surgery initiation. Receives: Drug: celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Measurements of Knee Society Score (KSS)
The Knee Society score is an assessment of the knee that comprises two arms, the functional ability and clinical examination scores, each with a 100-point denominator. One-hundred points are allocated to the functional capacity, including walking distance, stair-climbing ability, and the use of walking aids.
Measured: At the beginning of the study
Baseline range of motion (ROM)
Knee ROM was evaluated using a standard goniometer
Measured: At the beginning of the study
visual analogue scale (VAS)
Visual Analogue Scale (VAS) was used to evaluate the patient's postoperative pain intensity with a 0 to 10 rating scoring scale
Measured: 24 hours after the surgical procedure
Range of motion (ROM)
Knee ROM was evaluated using a standard goniometer
Measured: 6 months after surgery
Knee Society Score (KSS)
The Knee Society score is an assessment of the knee that comprises two arms, the functional ability and clinical examination scores, each with a 100-point denominator. One-hundred points are allocated to the functional capacity, including walking distance, stair-climbing ability, and the use of walking aids.
Measured: 6 months after surgery
visual analogue scale (VAS)
Visual Analogue Scale (VAS) was used to evaluate the patient's postoperative pain intensity with a 0 to 10 rating scoring scale
Measured: 48 hours after the surgical procedure
visual analogue scale (VAS)
Visual Analogue Scale (VAS) was used to evaluate the patient's postoperative pain intensity with a 0 to 10 rating scoring scale
Measured: Six weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start1 Jan 2021
- Primary completion1 Feb 2022
- Study completion1 Mar 2022
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Shafa, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324995
- Sponsor's protocol ID
- 394048
- Status last verified
- Apr 2022
- First submitted
- 8 Jan 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is confirmed to IPD be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Pre-emptive Injection of Peri-Articular-Multimodal Drug With Oral Celecoxib for Postoperative Pain Management in Total Knee Arthroplasty: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05324995
- Acronym / sponsor ID
- 394048
- Conditions
- Postoperative Pain, Total Knee Arthroplasty
- Keywords
- Total knee arthroplasty, Pain, Multimodal analgesia, Range of motion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 13 Apr 2022 (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.
This study is a randomized-clinical-trial on 146 patients candidate for total knee arthroplasty (TKA) who were randomly allocated to three treatment groups, including 1) a cocktail consisting of bupivacaine, morphine, epinephrine, and ketorolac (n=48), 2) only epinephrine (placebo group) (n=49), and 3) 400mg celecoxib orally (control group) (n=49) using Random Allocation software. The injections and oral therapy were performed within 15 minutes before the surgical procedure. The study's primary outcome was the Knee Society Score (KSS) calculated at baseline, within six weeks and six months postoperatively. Range of motion (ROM) and Visual Analogue Scale (VAS) to assess pain intensity as the other primary outcomes were evaluated before the procedure, within 24 hours, 48 hours, and six weeks postoperatively.
Detailed description
This randomized clinical trial conducted on 146 patients undergone TKA in orthopedic hospitals affiliated at Isfahan University of Medical Science (IUMS) in 2021.
The presence of osteoarthritis, making the patients candidate for primary unilateral total knee arthroplasty (TKA), and body mass index of 20-30 kg/m2 were determined as inclusion criteria.
The Regional Bioethics Committee of IUMS approved the study protocol. This study was designed as a census study; therefore, all the patients who met the criteria for participation in this study were recruited. Participants were randomly divided into three groups using Random Allocation software, so each patient was provided with a specific number from 1-to-146 by the software and allocated to one of the groups.
The investigator who performed the baseline and follow-up assessments and the patients were unaware of the study group; as the investigator was absent at the time of the surgery and all the patients administered a pill prior to the surgical procedure (one group was treated with celecoxib and the other two ones administered placebo similar in shape and color with celecoxib).
The primary outcome was the Knee Society Score (KSS) calculated at baseline, within six weeks and six months postoperatively. Range of motion (ROM) and Visual Analogue Scale (VAS) to assess pain intensity as the other primary outcomes were evaluated before the procedure, within 24 hours, 48 hours, and six weeks postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multimodal injection | Experimental | Drug: Multimodal DrugThe first group was treated using a preemptive periarticular injection of multimodal drugs. Therefore, a combination of drugs consisted of 50 mg bupivacaine hydrochloride 0.5% (AstraZeneca, Cenexi, France), 1 ml morphine sulfate 10 mg/ml (DarouPakhsh, Tehran, Iran), 300 mcg epinephrine (1:1000) (DarouPakhsh, Tehran, Iran) and 30 mg ketorolac (Caspian Tamin, Rasht, Iran) diluted by 0.9% sodium chloride solution to make a total 100 ml of injection drug was injected in periarticular area. The injections were done within 15 minutes before the incision in seven areas of the joint as followed: 15 ml in posterolateral soft tissue and lateral femoral periosteum, 15 ml posteromedial soft tissue and medial femoral periosteum, 20 ml inferomedial capsule, 20 ml superomedial capsule, 10 ml lateral capsule, 10 ml medial subcutaneous tissues and 10 ml lateral subcutaneous tissue. |
| epinephrine group (placebo group) | Experimental | Drug: epinephrineThe second group received 300 mcg epinephrine (1:1000) (DarouPakhsh, Tehran, Iran) peri-articulary, similar to the first group. |
| celecoxib group (control group) | Experimental | Drug: celecoxibThe third group administered celecoxib (200 mg) orally immediately before the surgery initiation. |
Who may qualify
- Ages
- 37 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of osteoarthritis
- Candidate for primary unilateral TKA
- Body mass index of 20-30 kg/m2
Key exclusion criteria (2 listed)
- Unable to follow-up the assessments
- Having more than 20% defects in medical records
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 |
|---|---|---|
| Multimodal DrugAlso: CaseThe Multimodal Drug group received morphine, epinephrine, and ketorolac (n=48), The epinephrine group (placebo group) (n=49) received 300 mcg epinephrine (1:1000) (DarouPakhsh, Tehran, Iran) peri-articulary,and the celecoxib group(control group)(n=49) recieved 400mg celecoxib orally | Drug | Multimodal injection |
| epinephrineAlso: PlaceboThe second group received 300 mcg epinephrine (1:1000) (DarouPakhsh, Tehran, Iran) peri-articulary | Drug | epinephrine group (placebo group) |
| celecoxibAlso: ControlThe third group administered celecoxib (200 mg) orally immediately before the surgery | Drug | celecoxib group (control group) |
Primary outcome
Baseline Measurements of Knee Society Score (KSS)
Time frame: At the beginning of the study
The Knee Society score is an assessment of the knee that comprises two arms, the functional ability and clinical examination scores, each with a 100-point denominator. One-hundred points are allocated to the functional capacity, including walking distance, stair-climbing ability, and the use of walking aids.
Baseline range of motion (ROM)
Time frame: At the beginning of the study
Knee ROM was evaluated using a standard goniometer
visual analogue scale (VAS)
Time frame: 24 hours after the surgical procedure
Visual Analogue Scale (VAS) was used to evaluate the patient's postoperative pain intensity with a 0 to 10 rating scoring scale
Range of motion (ROM)
Time frame: 6 months after surgery
Knee ROM was evaluated using a standard goniometer
Knee Society Score (KSS)
Time frame: 6 months after surgery
The Knee Society score is an assessment of the knee that comprises two arms, the functional ability and clinical examination scores, each with a 100-point denominator. One-hundred points are allocated to the functional capacity, including walking distance, stair-climbing ability, and the use of walking aids.
visual analogue scale (VAS)
Time frame: 48 hours after the surgical procedure
Visual Analogue Scale (VAS) was used to evaluate the patient's postoperative pain intensity with a 0 to 10 rating scoring scale
visual analogue scale (VAS)
Time frame: Six weeks after surgery
Visual Analogue Scale (VAS) was used to evaluate the patient's postoperative pain intensity with a 0 to 10 rating scoring 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 14 Apr 2022.
- Individual participant dataSharing planned: Yes. It is confirmed to IPD be shared with other researchers
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Multimodal Drug, epinephrine and celecoxib in people with Postoperative Pain and Total Knee Arthroplasty, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 2 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 14 Apr 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 Iran. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Baseline Measurements of Knee Society Score (KSS) (time frame: At the beginning of the study). The study lists 7 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 14 Apr 2022.