Knee ReplacementPhase 4NCT04314505
Opioid-Sparing Protocol Comparing With Opioid-based Protocol After Bilateral Total Knee Arthroplasty
A Phase 4 study testing Opioid-Sparing Protocol in people with Knee Replacement and Postoperative Pain, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
The concern for the opioid use in the total knee arthroplasty continues to rise in recent decades. Historically, the total knee arthroplasty consumed high doses opioids in the postoperative periods. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Replacement, Postoperative Pain, Opioid Use
- What is being tested?
- Opioid-Sparing Protocol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Mar 2020to 20 Aug 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patient with bilateral advanced knee osteoarthritis undergoing simultaneous bilateral total knee arthroplasty surgery
- willing to participate in this study and randomly allocated to either opioid-sparing protocol or PCA protocol.
Who cannot join
- patient who refused to participate or with contraindication or hypersensitivity to any of the study drugs
- chronic pain disorder (exceeding 50 mg oral morphine equivalence per day at time of recruitment)
- substance abuse (e.g. alcoholism)
- severe renal impairment.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital
Taipei City, Taipei, 112
Shang-Wen Tsai, Dr., +886-2-28717557, swtsai.vghtpe@gmail.com
About this study
Official title: Opioid-Sparing Protocol Using for Postoperative Pain Management Comparing With Opioid-based Patient Control Analgesia After Simultaneous Bilateral Total Knee Arthroplasty: a Randomized Controlled Trial
The concern for the opioid use in the total knee arthroplasty continues to rise in recent decades. Historically, the total knee arthroplasty consumed high doses opioids in the postoperative periods. Compared to the Opioid-Based patient controlled analgesia(PCA), the opioid-sparing protocol may have benefits to decrease the concerns of the opioid use and opioid-related complication and provides the equivalent efficacy for pain control. The purpose of this trial in to provide a novel opioid-sparing protocol (OSP) to evaluate the efficacy for pain control and reducing the immediate postoperative opioid consumption.
- Conditions
- Knee Replacement, Postoperative Pain, Opioid Use
- Being tested
- Opioid-Sparing Protocol, Opioid-Based Patient Controlled Analgesia
- Keywords
- Bilateral Total Knee Arthroplasty, Opioid Use, Opioid Sparing, Postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid-Sparing ProtocolDrug
Also called OSP Protocol
After a general anesthesia procedure was performed, an experienced anesthesiologist performed ultrasound guided adductor canal block procedures on both knees. In the opioid-sparing group, a dose of Parecoxib sodium 40 mg was administrated through intravenous route before the incision. After the surgery, Parecoxib sodium 40 mg was given intravenously every 12 hours for 4 more doses. Before the wound closure, the periarticular injection (each side 10 ml of 0.25% Bupivacaine) was done. The total dosage would be recorded in the device. All patients received oral paracetamol 500mg, 4 times a day and oral celecoxib 200mg, 2 times a day after surgery.
Opioid-Based Patient Controlled AnalgesiaDrug
Also called PCA Protocol
After a general anesthesia procedure was performed, an experienced anesthesiologist performed ultrasound guided adductor canal block procedures on both knees. The patient was informed that the intravenous bolus of rescue morphine (4mg) was available every 4 hours if the pain was intolerable. In the PCA group, the device was applied before incision and the initial setting was 0.01mg/kg*hour, patient-controlled dose 2 mg, lock-out 5 minutes and limited 40mg in each 4 hours. After the surgery, the staff of PCA group would visit the patients and adjusted the dosage. The PCA was removed after 72 hours from the surgery. Before the wound closure, the periarticular injection (each side 10 ml of 0.25% Bupivacaine) was done. The total dosage would be recorded in the device. All patients received oral paracetamol 500mg, 4 times a day and oral celecoxib 200mg, 2 times a day after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Opioid Sparing Protocol | Experimental | Preemptive(before incision): Parecoxib sodium 40 mg Postoperative: Parecoxib sodium 40 mg was given intravenously every 12 hours for 4 more doses. Receives: Drug: Opioid-Sparing Protocol |
| Opioid Based Patient Controlled Analgesia | Active comparator | Preemptive(before incision) and Postoperative: the initial setting was 0.01mg/kg*hour, patient-controlled dose 2 mg, lock-out 5 minutes and limited 40mg in each 4 hours; adjusted by the PCA staff Receives: Drug: Opioid-Based Patient Controlled Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Post-operative 6 hours
Measured: Post-operative 6 hours after surgery
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Post-operative 12 hours
Measured: Post-operative 12 hours after surgery
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Post-operative 24 hours
Measured: Post-operative 24 hours after surgery
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Post-operative 48 hours
Measured: Post-operative 48 hours after surgery
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Post-operative 72 hours
Measured: Post-operative 72 hours after surgery
Pain scores using numerical rating scale (VAS, 0 to 10) at motion
Post-operative 24 hours
Measured: Post-operative 24 hours after surgery
Pain scores using numerical rating scale (VAS, 0 to 10) at motion
Post-operative 48 hours
Measured: Post-operative 48 hour hours after surgery
Pain scores using numerical rating scale (VAS, 0 to 10) at motion
Post-operative 72 hours
Measured: Post-operative 72 hour hours after surgery
Secondary outcomes (5)
maximum angle of continuous passive motion (CPM) as tolerated (Degrees)
recorded at post-operative 24 hours, 48 hours and 72 hours
Measured: 0-72 hours after surgery
Cumulative morphine consumption(mg)
recorded at post-operative 24 hours, 48 hours and 72 hours
Measured: 0-72 hours after surgery
drug-related (opioid) adverse events
nausea/vomiting, dizziness, urinary retention, pruritus, dry mouth, constipation, dyspepsia, GI bleeding, pitting edema over lower extremities, cardiovascular event, respiratory depression, delirium or coma
Measured: 0-72 hours after surgery
Satisfaction scale (0-100 points)
satisfaction with regard to the efficacy and safety of the pain management protocol.
Measured: postoperative 2 weeks after surgery
Length of hospital stay (LOS) (Days)
Time from admission to discharge
Measured: After surgery until discharge (about 3-5 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start20 Mar 2020
- Primary completion20 Jun 2020
- Study completion20 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ReplacementStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shang-Wen Tsai, M.D., Study director, Department of Orthopaedic and Traumatology, Taipei Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314505
- Sponsor's protocol ID
- 2020-02-008C
- Status last verified
- Jul 2020
- First submitted
- 12 Mar 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- 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 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid-Sparing Protocol Using for Postoperative Pain Management Comparing With Opioid-based Patient Control Analgesia After Simultaneous Bilateral Total Knee Arthroplasty: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04314505
- Acronym / sponsor ID
- 2020-02-008C
- Conditions
- Knee Replacement, Postoperative Pain, Opioid Use
- Keywords
- Bilateral Total Knee Arthroplasty, Opioid Use, Opioid Sparing, Postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 20 Aug 2020 (estimated)
- First posted
- 19 Mar 2020 (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.
The concern for the opioid use in the total knee arthroplasty continues to rise in recent decades. Historically, the total knee arthroplasty consumed high doses opioids in the postoperative periods. Compared to the Opioid-Based patient controlled analgesia(PCA), the opioid-sparing protocol may have benefits to decrease the concerns of the opioid use and opioid-related complication and provides the equivalent efficacy for pain control. The purpose of this trial in to provide a novel opioid-sparing protocol (OSP) to evaluate the efficacy for pain control and reducing the immediate postoperative opioid consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid Sparing Protocol | Experimental | Drug: Opioid-Sparing ProtocolPreemptive(before incision): Parecoxib sodium 40 mg Postoperative: Parecoxib sodium 40 mg was given intravenously every 12 hours for 4 more doses. |
| Opioid Based Patient Controlled Analgesia | Active comparator | Drug: Opioid-Based Patient Controlled AnalgesiaPreemptive(before incision) and Postoperative: the initial setting was 0.01mg/kg*hour, patient-controlled dose 2 mg, lock-out 5 minutes and limited 40mg in each 4 hours; adjusted by the PCA staff |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient with bilateral advanced knee osteoarthritis undergoing simultaneous bilateral total knee arthroplasty surgery
- willing to participate in this study and randomly allocated to either opioid-sparing protocol or PCA protocol.
Key exclusion criteria (4 listed)
- patient who refused to participate or with contraindication or hypersensitivity to any of the study drugs
- chronic pain disorder (exceeding 50 mg oral morphine equivalence per day at time of recruitment)
- substance abuse (e.g. alcoholism)
- severe renal 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 |
|---|---|---|
| Opioid-Sparing ProtocolAlso: OSP ProtocolAfter a general anesthesia procedure was performed, an experienced anesthesiologist performed ultrasound guided adductor canal block procedures on both knees. In the opioid-sparing group, a dose of Parecoxib sodium 40 mg was administrated through intravenous route before the incision. After the surgery, Parecoxib sodium 40 mg was given intravenously every 12 hours for 4 more doses. Before the wound closure, the periarticular injection (each side 10 ml of 0.25% Bupivacaine) was done. The total dosage would be recorded in the device. All patients received oral paracetamol 500mg, 4 times a day and oral celecoxib 200mg, 2 times a day after surgery. | Drug | Opioid Sparing Protocol |
| Opioid-Based Patient Controlled AnalgesiaAlso: PCA ProtocolAfter a general anesthesia procedure was performed, an experienced anesthesiologist performed ultrasound guided adductor canal block procedures on both knees. The patient was informed that the intravenous bolus of rescue morphine (4mg) was available every 4 hours if the pain was intolerable. In the PCA group, the device was applied before incision and the initial setting was 0.01mg/kg*hour, patient-controlled dose 2 mg, lock-out 5 minutes and limited 40mg in each 4 hours. After the surgery, the staff of PCA group would visit the patients and adjusted the dosage. The PCA was removed after 72 hours from the surgery. Before the wound closure, the periarticular injection (each side 10 ml of 0.25% Bupivacaine) was done. The total dosage would be recorded in the device. All patients received oral paracetamol 500mg, 4 times a day and oral celecoxib 200mg, 2 times a day after surgery. | Drug | Opioid Based Patient Controlled Analgesia |
Primary outcome
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Time frame: Post-operative 6 hours after surgery
Post-operative 6 hours
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Time frame: Post-operative 12 hours after surgery
Post-operative 12 hours
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Time frame: Post-operative 24 hours after surgery
Post-operative 24 hours
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Time frame: Post-operative 48 hours after surgery
Post-operative 48 hours
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Time frame: Post-operative 72 hours after surgery
Post-operative 72 hours
Pain scores using numerical rating scale (VAS, 0 to 10) at motion
Time frame: Post-operative 24 hours after surgery
Post-operative 24 hours
Pain scores using numerical rating scale (VAS, 0 to 10) at motion
Time frame: Post-operative 48 hour hours after surgery
Post-operative 48 hours
Pain scores using numerical rating scale (VAS, 0 to 10) at motion
Time frame: Post-operative 72 hour hours after surgery
Post-operative 72 hours
5 secondary outcomes
maximum angle of continuous passive motion (CPM) as tolerated (Degrees)
Time frame: 0-72 hours after surgery
Cumulative morphine consumption(mg)
Time frame: 0-72 hours after surgery
drug-related (opioid) adverse events
Time frame: 0-72 hours after surgery
Satisfaction scale (0-100 points)
Time frame: postoperative 2 weeks after surgery
Length of hospital stay (LOS) (Days)
Time frame: After surgery until discharge (about 3-5 days after surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- 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.
Shang-Wen Tsai, M.D. study director
Department of Orthopaedic and Traumatology, Taipei Veterans General Hospital
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 Opioid-Sparing Protocol in people with Knee Replacement and Postoperative Pain, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 4 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 21 Jul 2020. 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 Taiwan. 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 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 Hsuan-Hsiao Ma, M.D. (02-28717557, tyc20192@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores using numerical rating scale (VAS, 0 to 10) at rest (time frame: Post-operative 6 hours after surgery). The study lists 8 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 21 Jul 2020.