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NCT Number: NCT07176065

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

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Key information

Conditions

Postoperative Pain Management in Total Knee Arthroplasty Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universiti Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location contact

Ahmad Abid Amin, MBBS

CONTACT

[email protected]

+60133131064

Ahmad Fariz Elias, MD

PRINCIPAL_INVESTIGATOR

Nabilah Abdul Ghani, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Known allergy to study drugs
  • Chronic pain or neurological conditions
  • Bilateral or revision TKR
  • Significant deformity affecting function
  • Substance abuse history
  • Day-case surgery

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Total postoperative opioid consumption (MME)

    Time frame: 24 hours postoperatively

    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.

  2. Patient satisfaction with pain management

    Time frame: Postoperative day 1

    Patient satisfaction will be measured on postoperative day 1 using a 5-point Likert scale, ranging from "very dissatisfied" to "very satisfied."

  3. Incidence of adverse effects (sedation, bradycardia, hypotension, PONV)

    Time frame: Within 24 hours postoperatively

    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)

  4. Time to first ambulation

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmad Abid Amin, MBBS

CONTACT

[email protected]

+60133131064

Ahmad Fariz Elias, MD

CONTACT

[email protected]

+60194062520

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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