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

NCT07176065 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025429-15014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postoperative Pain Management in Total Knee Arthroplasty

Keywords

Total Knee Replacement; TKR; Periarticular Infiltration; Ropivacaine; Dexmedetomidine; Postoperative Pain; Opioid Consumption; Regional Anaesthesia; Adductor Canal Block

Outcome Measures

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.

  24 hours postoperatively (from time of skin closure)

Secondary Outcomes (4)

• Total postoperative opioid consumption (MME)

  24 hours postoperatively

• Patient satisfaction with pain management

  Postoperative day 1

• Incidence of adverse effects (sedation, bradycardia, hypotension, PONV)

  Within 24 hours postoperatively

• Time to first ambulation

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

Study Arms (2)

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.

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.

Drug: Ropivacaine + Dexmedetomidine

Interventions

Ropivacaine + saline solution DRUG

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

Ropivacaine + Saline

Ropivacaine + Dexmedetomidine DRUG

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

Ropivacaine + Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Universiti Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Related Links

• We also register our research protocol to national medical research registration Malaysia

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Saline Solution; Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Ahmad Fariz Elias, MD

CONTACT

+60194062520; fariz_elias@ummc.edu.my

Ahmad Abid Amin, MBBS

CONTACT

+60133131064; abid.amin@ummc.edu.my

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical specialist

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 16, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 2 years after completing of study
• Access Criteria: 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

Locations

MY (1)