Dexmedetomidine as an Adjunct to Periarticular Ropivacaine in Total Knee Replacement: A Pilot Randomised Controlled Trial

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Malaya

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥18 years

Undergoing elective unilateral total knee replacement

ASA physical status I-III

No known allergy to local anaesthetics or dexmedetomidine

Disqualifiers

Known allergy to study drugs

Chronic pain or neurological conditions

Bilateral or revision TKR

Significant deformity affecting function

Trial design

Design model

Single group

Treatments tested in this trial

  • Ropivacaine + saline solution

    Drug

    0.5% ropivacaine (19 mL) + 1 mL normal saline administered intraoperatively via periarticular injection.

  • Ropivacaine + Dexmedetomidine

    Drug

    0.5% ropivacaine (19 mL) + dexmedetomidine 100 µg in 1 mL administered intraoperatively via periarticular injection.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Ropivacaine + SalineActive comparator 1 intervention
Group B: Ropivacaine + DexmedetomidineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
24 hours postoperatively (from time of skin closure)

Secondary outcomes

1

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.

Time frame
24 hours postoperatively
2

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."

Time frame
Postoperative day 1
3

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)

Time frame
Within 24 hours postoperatively
4

Time to first ambulation

Time from skin closure to the patient's first unsupported ambulation (\>5 metres) will be recorded in hours.

Time frame
From end of surgery to first ambulation (within 24 hours)

Other outcomes

Sponsors and contacts

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