Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine + saline solution | Drug | 0.5% ropivacaine (19 mL) + 1 mL normal saline administered intraoperatively via periarticular injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours postoperatively (from time of skin closure) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours postoperatively |
| Patient satisfaction with pain management |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmad Fariz Elias, MD | Contact | +60194062520 | fariz_elias@ummc.edu.my | |
| Ahmad Abid Amin, MBBS | Contact | +60133131064 | abid.amin@ummc.edu.my |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universiti Malaya Medical Centre | Kuala Lumpur | Kuala Lumpur | 59100 | Malaysia |
Not provided
| Label | URL |
|---|---|
| We also register our research protocol to national medical research registration Malaysia | View source |
Not provided
Protocol and statistical analysis plan
Data collected from the study limited to demographic data, numerical rating scale and adverse event
2 years after completing of study
Editorial board that reviews my article for publication
They will have assess to our data collection, as we will keep the data in redcap server
Not provided
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.
Not provided
Not provided
The study will be conducted in a quadruple-blinded manner. Group allocation will be concealed using computer-generated randomisation and sequentially numbered, opaque, sealed envelopes. A designated research team member, not involved in patient care or outcome assessment, will prepare the study drug (ropivacaine + saline or ropivacaine + dexmedetomidine) in identical, pre-labelled syringes. The operating surgeon, participant, and outcomes assessor will remain blinded to group allocation throughout the study period.
| Ropivacaine + Dexmedetomidine | Drug | 0.5% ropivacaine (19 mL) + dexmedetomidine 100 µg in 1 mL administered intraoperatively via periarticular injection. |
|
Patient satisfaction will be measured on postoperative day 1 using a 5-point Likert scale, ranging from "very dissatisfied" to "very satisfied." |
| 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) | 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. | From end of surgery to first ambulation (within 24 hours) |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D000077330 | Saline Solution |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided