臨床研究等提出・公開システム

Date of registration	Jan. 19, 2026
Last modified on	Jan. 19, 2026
Trial ID	jRCT1030250650

Scientific Title	A double-blind randomized controlled trial to evaluate the efficacy of combined femoral nerve block and selective tibial nerve block for postoperative pain management in high tibial osteotomy.
Public Title	A double-blind randomized controlled trial to evaluate the efficacy of combined femoral nerve block and selective tibial nerve block for postoperative pain management in high tibial osteotomy.

Contact for Scientific Queries	Name	Kamiya Takefumi
	Affiliation	Nihon University Itabashi Hospital
	Address	tokyo itabashi ooyaguchikamimachi 30-1
	Telephone	+81-3-3972-8111
	E-mail	kamiya.takefumi@nihon-u.ac.jp
Contact for Public Queries	Name	Kamiya Takefumi
	Affiliation	Nihon University Itabashi Hospital
	Address	tokyo itabashi ooyaguchikamimachi 30-1
	Telephone	+81-339728111
	E-mail	kamiya.takefumi@nihon-u.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		Jan. 19, 2026
Target sample size		60
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients undergoing medial open wedge high tibial osteotomy at our hospital. 1) Patients over 20 years 2) Patients who receive written informed consent. 3) Patients with American Society of Anesthesiologists physical status classification 1-3.
	Exclusion Criteria	1. Patients who are deemed inappropriate as research subjects by the principal investigator 2. Patients who refuse to participate in the study. 3. Patients who have contraindications to the use of usual postoperative analgesics such as NSAIDs and acetaminophen, contraindications to local anesthetics, are pregnant or suspected pregnant women, poorly controlled diabetes, unable to understand the perioperative questionnaire (language or cognitive impairment), severe heart disease, Severe obesity (BMI > 35), patients who have not responded to nerve blocks, emergency surgery.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		osteoarthritis
Intervention(s)		General anesthesia combined with peripheral nerve blocks F group: Femoral nerve block alone FS group: Femoral nerve block combined with selective tibial nerve block
Primary Outcome(s)		NRS (Numerical Rating Scale) score in the postoperative recovery area and score 2, 4, 6, 12, 24 hours after surgery
Secondary Outcome(s)		Opioid consumption within 24 hours postoperatively, time to request adjunctive analgesics, and complications

Primary Sponsor	none

Name of Certified Review Board	Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address	tokyo itabashi ooyaguchikamimachi 30-1, Tokyo
Telephone	+81-3-3972-8111
E-Mail	med.itabashi.clinicalresearch@nihon-u.ac.jp
Approval Status	Approval
Date of approval	June. 11, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none