Postoperative Pain Management in Total Knee ArthroplastyPhase 4NCT07176065
Dexmedetomidine as an Adjunct to Periarticular Ropivacaine in Total Knee Replacement: A Pilot Randomised Controlled Trial
A Phase 4 study testing Ropivacaine + saline solution and Ropivacaine + Dexmedetomidine in people with Postoperative Pain Management in Total Knee Arthroplasty, run by University of Malaya at 1 site in Malaysia.
Trial summary
This study aims to evaluate whether adding dexmedetomidine to ropivacaine-based periarticular infiltration (PAI) improves postoperative pain control in patients undergoing total knee replacement (TKR). Despite standard pain management, many patients continue to experience moderate-to-severe pain after surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Postoperative Pain Management in Total Knee Arthroplasty
- What is being tested?
- Ropivacaine + saline solution and Ropivacaine + Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- Oct 2025to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years
- Undergoing elective unilateral total knee replacement
- ASA physical status I-III
- No known allergy to local anaesthetics or dexmedetomidine
- No opioid use >24 hours preoperatively
- Provided informed consent
Who cannot join
- Known allergy to study drugs
- Chronic pain or neurological conditions
- Bilateral or revision TKR
- Significant deformity affecting function
- Substance abuse history
- Day-case surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Universiti Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
Ahmad Abid Amin, MBBS, +60133131064, abid.amin@ummc.edu.my
Ahmad Fariz Elias, MD
About this study
Official title: A Pilot Randomized Controlled Trial Assessing the Impact of Dexmedetomidine as an Adjunct to Periarticular Ropivacaine Infiltration on Postoperative Pain and Recovery in Patients Undergoing Total Knee Replacement
This study aims to evaluate whether adding dexmedetomidine to ropivacaine-based periarticular infiltration (PAI) improves postoperative pain control in patients undergoing total knee replacement (TKR). Despite standard pain management, many patients continue to experience moderate-to-severe pain after surgery. Dexmedetomidine, a sedative and analgesic agent, may help prolong the effect of local anaesthetics. A total of 60 patients will be randomly assigned to receive either ropivacaine alone or ropivacaine with dexmedetomidine. Pain scores, opioid use, side effects, and recovery time will be monitored for 24 hours. The goal is to determine if this method is more effective and safer for improving recovery after knee surgery.
Read the detailed description
Total knee replacement is associated with significant postoperative pain despite the use of multimodal analgesia. Periarticular infiltration (PAI) using local anaesthetics such as ropivacaine has become a common component of pain control protocols but offers a limited duration of relief. Dexmedetomidine, a selective α2-adrenergic agonist, has demonstrated analgesic benefits as an adjuvant in peripheral nerve blocks, but its role in PAI remains underexplored.
This double-blind randomised controlled trial will recruit 60 adult patients undergoing unilateral total knee replacement at Universiti Malaya Medical Centre. Patients will be randomly assigned to receive either PAI with 0.5% ropivacaine alone (control group) or ropivacaine combined with 100 µg dexmedetomidine (intervention group). All patients will receive spinal anaesthesia and an adductor canal block before surgery.
Pain scores will be recorded using the Numerical Rating Scale (NRS) at 1, 6, 12, and 24 hours postoperatively. Secondary outcomes include 24-hour opioid consumption (morphine milligram equivalents), patient satisfaction (5-point Likert scale), adverse effects (sedation, bradycardia, hypotension, PONV), and time to first ambulation. This study will provide important feasibility data and inform the design of a future multicentre trial, particularly within the Malaysian population.
- Being tested
- Ropivacaine + saline solution, Ropivacaine + Dexmedetomidine
- Keywords
- Total Knee Replacement, TKR, Periarticular Infiltration, Ropivacaine, Dexmedetomidine, Postoperative Pain, Opioid Consumption, Regional Anaesthesia, Adductor Canal Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine + saline solutionDrug
0.5% ropivacaine (19 mL) + 1 mL normal saline administered intraoperatively via periarticular injection.
Ropivacaine + DexmedetomidineDrug
0.5% ropivacaine (19 mL) + dexmedetomidine 100 µg in 1 mL administered intraoperatively via periarticular injection.
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine + Saline | Active comparator | Patients will receive 20 mL of periarticular infiltration consisting of 19 mL of 0.5% ropivacaine and 1 mL of normal saline during total knee replacement. Receives: Drug: Ropivacaine + saline solution |
| Ropivacaine + Dexmedetomidine | Experimental | Patients will receive 20 mL of periarticular infiltration consisting of 19 mL of 0.5% ropivacaine and 100 µg dexmedetomidine in 1 mL during total knee replacement. Receives: Drug: Ropivacaine + Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour postoperative pain score (NRS 0-10) at rest and during movement
Pain intensity will be assessed using the Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates worst possible pain. Measurements will be taken at rest and during passive knee flexion to 90°, at 1, 6, 12, and 24 hours postoperatively. The primary endpoint is the NRS score at 24 hours.
Measured: 24 hours postoperatively (from time of skin closure)
Secondary outcomes (4)
Total postoperative opioid consumption (MME)
Total opioid use in the first 24 hours postoperatively will be recorded from the PCA pump. All opioids will be converted into morphine milligram equivalents (MME) for standardisation.
Measured: 24 hours postoperatively
Patient satisfaction with pain management
Patient satisfaction will be measured on postoperative day 1 using a 5-point Likert scale, ranging from "very dissatisfied" to "very satisfied."
Measured: Postoperative day 1
Incidence of adverse effects (sedation, bradycardia, hypotension, PONV)
Adverse effects will be monitored and recorded within 24 hours postoperatively:
Sedation (RASS ≤ -2) Bradycardia (HR < 50 bpm) Hypotension (MAP < 65 mmHg or SBP < 90 mmHg) PONV (score ≥1 on 0-4 scale)
Measured: Within 24 hours postoperatively
Time to first ambulation
Time from skin closure to the patient's first unsupported ambulation (>5 metres) will be recorded in hours.
Measured: From end of surgery to first ambulation (within 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain Management in Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Single group
- Model description
- This is a two-arm, parallel-group, quadruple-blinded randomised controlled trial. Sixty adult patients undergoing unilateral total knee replacement will be randomly assigned in a 1:1 ratio to receive periarticular infiltration with either ropivacaine alone (control group) or ropivacaine combined with 100 µg dexmedetomidine (intervention group). Allocation will be concealed using computer-generated block randomisation and sealed opaque envelopes. Blinding will be maintained for participants, care providers, investigators, and outcomes assessors. The intervention will be administered intraoperatively as a single dose.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Fariz Bin Elias, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176065
- Sponsor's protocol ID
- 2025429-15014
- Status last verified
- May 2025
- First submitted
- 8 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol and statistical analysis plan Data collected from the study limited to demographic data, numerical rating scale and adverse event
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial Assessing the Impact of Dexmedetomidine as an Adjunct to Periarticular Ropivacaine Infiltration on Postoperative Pain and Recovery in Patients Undergoing Total Knee Replacement
- ClinicalTrials.gov ID
- NCT07176065
- Acronym / sponsor ID
- 2025429-15014
- Keywords
- Total Knee Replacement, TKR, Periarticular Infiltration, Ropivacaine, Dexmedetomidine, Postoperative Pain, Opioid Consumption, Regional Anaesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Sep 2025 (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 aims to evaluate whether adding dexmedetomidine to ropivacaine-based periarticular infiltration (PAI) improves postoperative pain control in patients undergoing total knee replacement (TKR). Despite standard pain management, many patients continue to experience moderate-to-severe pain after surgery. Dexmedetomidine, a sedative and analgesic agent, may help prolong the effect of local anaesthetics. A total of 60 patients will be randomly assigned to receive either ropivacaine alone or ropivacaine with dexmedetomidine. Pain scores, opioid use, side effects, and recovery time will be monitored for 24 hours. The goal is to determine if this method is more effective and safer for improving recovery after knee surgery.
Detailed description
Total knee replacement is associated with significant postoperative pain despite the use of multimodal analgesia. Periarticular infiltration (PAI) using local anaesthetics such as ropivacaine has become a common component of pain control protocols but offers a limited duration of relief. Dexmedetomidine, a selective α2-adrenergic agonist, has demonstrated analgesic benefits as an adjuvant in peripheral nerve blocks, but its role in PAI remains underexplored.
This double-blind randomised controlled trial will recruit 60 adult patients undergoing unilateral total knee replacement at Universiti Malaya Medical Centre. Patients will be randomly assigned to receive either PAI with 0.5% ropivacaine alone (control group) or ropivacaine combined with 100 µg dexmedetomidine (intervention group). All patients will receive spinal anaesthesia and an adductor canal block before surgery.
Pain scores will be recorded using the Numerical Rating Scale (NRS) at 1, 6, 12, and 24 hours postoperatively. Secondary outcomes include 24-hour opioid consumption (morphine milligram equivalents), patient satisfaction (5-point Likert scale), adverse effects (sedation, bradycardia, hypotension, PONV), and time to first ambulation. This study will provide important feasibility data and inform the design of a future multicentre trial, particularly within the Malaysian population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group, quadruple-blinded randomised controlled trial. Sixty adult patients undergoing unilateral total knee replacement will be randomly assigned in a 1:1 ratio to receive periarticular infiltration with either ropivacaine alone (control group) or ropivacaine combined with 100 µg dexmedetomidine (intervention group). Allocation will be concealed using computer-generated block randomisation and sealed opaque envelopes. Blinding will be maintained for participants, care providers, investigators, and outcomes assessors. The intervention will be administered intraoperatively as a single dose.
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine + Saline | Active comparator | Drug: Ropivacaine + saline solutionPatients will receive 20 mL of periarticular infiltration consisting of 19 mL of 0.5% ropivacaine and 1 mL of normal saline during total knee replacement. |
| Ropivacaine + Dexmedetomidine | Experimental | Drug: Ropivacaine + DexmedetomidinePatients will receive 20 mL of periarticular infiltration consisting of 19 mL of 0.5% ropivacaine and 100 µg dexmedetomidine in 1 mL during total knee replacement. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥18 years
- Undergoing elective unilateral total knee replacement
- ASA physical status I-III
- No known allergy to local anaesthetics or dexmedetomidine
- No opioid use >24 hours preoperatively
Key exclusion criteria (6 listed)
- Known allergy to study drugs
- Chronic pain or neurological conditions
- Bilateral or revision TKR
- Significant deformity affecting function
- Substance abuse history
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 |
|---|---|---|
| Ropivacaine + saline solution0.5% ropivacaine (19 mL) + 1 mL normal saline administered intraoperatively via periarticular injection. | Drug | Ropivacaine + Saline |
| Ropivacaine + Dexmedetomidine0.5% ropivacaine (19 mL) + dexmedetomidine 100 µg in 1 mL administered intraoperatively via periarticular injection. | Drug | Ropivacaine + Dexmedetomidine |
Primary outcome
24-hour postoperative pain score (NRS 0-10) at rest and during movement
Time frame: 24 hours postoperatively (from time of skin closure)
Pain intensity will be assessed using the Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates worst possible pain. Measurements will be taken at rest and during passive knee flexion to 90°, at 1, 6, 12, and 24 hours postoperatively. The primary endpoint is the NRS score at 24 hours.
4 secondary outcomes
Total postoperative opioid consumption (MME)
Time frame: 24 hours postoperatively
Patient satisfaction with pain management
Time frame: Postoperative day 1
Incidence of adverse effects (sedation, bradycardia, hypotension, PONV)
Time frame: Within 24 hours postoperatively
Time to first ambulation
Time frame: From end of surgery to first ambulation (within 24 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- We also register our research protocol to national medical research registration MalaysiaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Protocol and statistical analysis plan Data collected from the study limited to demographic data, numerical rating scale and adverse event
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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.
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 Ropivacaine + saline solution and Ropivacaine + Dexmedetomidine in people with Postoperative Pain Management in Total Knee Arthroplasty, run by University of Malaya at 1 site in Malaysia.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 16 Sep 2025. 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 Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmad Fariz Elias, MD (+60194062520, fariz_elias@ummc.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour postoperative pain score (NRS 0-10) at rest and during movement (time frame: 24 hours postoperatively (from time of skin closure)). 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 16 Sep 2025.