Skip to content

Efficacy of caudal epidural morphine for pain relief after total knee replacement surgery

Postoperative analgesic efficacy of caudal epidural morphine in total knee arthroplasty: a pilot randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1031250641
Enrollment
60
Registered
2026-01-13
Start date
2026-01-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis requiring total knee arthroplasty total knee arthroplasty, postoperative pain

Interventions

Both groups: Femoral triangle block (0.25% levobupivacaine 20mL) + iPACK block (0.25% levobupivacaine 20mL). Intervention group additionally receives caudal epidural morphine (normal saline 10mL + mo
caudal epidural morphine, femoral triangle block, iPACK block

Sponsors

Nakazawa Keisuke
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years or older 2. ASA-PS classification 3 or less 3. Patients undergoing primary total knee arthroplasty 4. Written informed consent obtained

Exclusion criteria

Exclusion criteria: 1. Allergy to amide-type local anesthetics 2. Allergy to morphine or other opioids 3. Patients on anticoagulation therapy with PT-INR greater than 1.2 or dual antiplatelet therapy 4. Moderate to severe hepatic dysfunction (Child-Pugh class B or higher) 5. Moderate to severe renal dysfunction (eGFR less than 30 mL/min/1.73m2) 6. Diagnosed or suspected sleep apnea syndrome 7. Chronic opioid users (continuous use for more than 3 months) 8. Pregnant or breastfeeding women

Design outcomes

Primary

MeasureTime frame
Numerical Rating Scale (NRS) score (0-10 scale) during knee flexion on postoperative day 1 morning (6-8 AM)

Secondary

MeasureTime frame
NRS during movement at each time point (extubation, 2h, 6h, 12h, 21:00 before sleep, 24h), NRS at rest at each time point, proportion of patients experiencing NRS 4 or greater during movement within 24 hours, total IV-PCA consumption in 24 hours, incidence of opioid-related side effects (nausea/vomiting, pruritus, respiratory depression)

Contacts

Public ContactKeisuke Nakazawa

Nihon University Itabashi Hospital

nakazawa.keisuke@nihon-u.ac.jp+81-3-3972-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026