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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2028-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Postoperative Pain Management in Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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.

Study Groups

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Ropivacaine + Saline

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.

Group Type ACTIVE_COMPARATOR

Ropivacaine + saline solution

Intervention Type DRUG

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

Ropivacaine + Dexmedetomidine

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.

Group Type EXPERIMENTAL

Ropivacaine + Dexmedetomidine

Intervention Type DRUG

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

Interventions

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Ropivacaine + saline solution

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

Intervention Type DRUG

Ropivacaine + Dexmedetomidine

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No