Triple-masked randomized comparison of 5mL or 20mL levobupivacaine to femoral triangle block for total knee arthroplasty

Triple-masked randomized comparison of 5mL or 20mL levobupivacaine to femoral triangle block for total knee arthroplasty - Triple-masked randomized comparison of 5mL or 20mL levobupivacaine to femoral triangle block for total knee arthroplasty

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031890

Enrollment

120

Registered

2018-03-25

Start date

2018-03-21

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 or knee rheumatoid arthritis

Interventions

Group LV(Low volume): preoperative femoral triangle block with 0.5% levobupivacaine 5mL Group HV(High volume): preoperative femoral triangle block with 0.125% levobupivacaine 20mL

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients scheduled unilateral total knee arthroplasty at Daiyukai General Hospital 2.Adults (>=20 years) with American Society of Anaesthesiologists Physical Status Classification I-III 3.Participants were scheduled for primary unilateral TKA for osteoarthritis 4.Written informed consent is provided

Exclusion criteria

Exclusion criteria: 1.Inability to communicate lucidly 2.Bilateral TKA 3.revision knee arthroplasty 4.Under 20 years old 5.Allergy to any of the drugs used in this study 6.ASA-PS > III 7.Chronic opioid use 8.Diabetes mellitus with sensory disorders 9.Neurological disability 10.Infections around femoral crease 11.Platelet < 5.0 * 10^4 /mcl 12.Pregnancy, possibility of pregnancy, or breast-feeding women 13.Contraindications to peripheral nerve blocks

Design outcomes

Primary

Measure	Time frame
Attainment time of early discharge criteria	—

Secondary

Measure	Time frame
Postoperative pain score (VRS)(Postoperative 1 hour, time point per 8 hours till postoperative 72 hours) Postoperative motor function (24, 48, 72 hours) Postoperative rehabilitation score and muscle power(24, 48, 72 hours) Consumption of postoperative additional analgesics(72 hours) Complication(72 hours)	—

Countries

Japan

Contacts

Public ContactNorihiro Sakai

Daiyukai General Hospital Dep. Anaesthesiplogy

sakayline@anes.med.osaka-u.ac.jp+81-586-72-1211

Outcome results

None listed

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