臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 24, 2025
Last modified on	Dec. 24, 2025
Trial ID	jRCT1031250596

Scientific Title	A Randomized Controlled Trial Evaluating Concentration-Volume Effects of Local Anesthetic Administration in the Lateral Pterygoid Muscle (OPTIMAL Study: Outcome comparison of Pterygoid muscle Targeted Injection with Modified Anesthetic Loading) (OPTIMAL Study)
Public Title	Comparison of anesthetic concentration and volume for pain relief after wisdom tooth extraction (OPTIMAL Study)

Contact for Scientific Queries	Name	Nakazawa Keisuke
	Affiliation	Nihon University Itabashi Hospital
	Address	30-1 Oyaguchikamimachi, Itabashi-ku, Tokyo
	Telephone	+81-3-3972-8111
	E-mail	nakazawa.keisuke@nihon-u.ac.jp
Contact for Public Queries	Name	Nakazawa Keisuke
	Affiliation	Nihon University Itabashi Hospital
	Address	30-1 Oyaguchikamimachi, Itabashi-ku, Tokyo
	Telephone	+81-3-3972-8111
	E-mail	nakazawa.keisuke@nihon-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 24, 2025
Target sample size		60
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Adults aged 18 years or older 2. Scheduled for impacted wisdom tooth extraction under general anesthesia with ASA-PS classification 1 or 2 3. Able to provide written informed consent and communicate in Japanese
	Exclusion Criteria	1. History of allergy to amide-type local anesthetics 2. Pregnant or breastfeeding 3. Severe hepatic impairment (Child-Pugh class B or higher) 4. Severe renal impairment (eGFR less than 30mL/min/1.73m2) 5. Anticoagulation therapy with PT-INR greater than 1.5 6. Under treatment for chronic pain 7. History of severe psychiatric disorders 8. Limited mouth opening (maximum opening less than 25mm) 9. Refusal to participate in the study
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Impacted wisdom tooth
Intervention(s)		Group A (High-volume group): Ultrasound-guided lateral pterygoid muscle block with 0.25% ropivacaine 10mL after general anesthesia induction, plus local wound infiltration. Group B (Low-volume group): Same technique with 0.75% ropivacaine 3.3mL, plus local wound infiltration. Group C (Control group): Local wound infiltration only, without additional nerve block.
Health Condition(s) Keyword		Impacted wisdom tooth, Third molar, Tooth extraction
Intervention(s) Keyword		Lateral pterygoid muscle block, Local anesthesia, Ultrasound-guided
Health Condition(s) Code		D014095
Intervention(s) Code		D009407
Primary Outcome(s)		Pain intensity at rest 6 hours postoperatively, assessed using the Numerical Rating Scale (NRS 0-10)
Secondary Outcome(s)		1. Pain scores (NRS 0-10) at extubation, 2h, 6h, bedtime (21:00), 7am next day, and 10am next day (before discharge) at rest and on mouth opening 2. Time to first rescue analgesic (hours) 3. Total analgesic consumption within 24 hours 4. Number of rescue analgesic doses 5. Incidence of postoperative nausea and vomiting (PONV) 6. Presence of trismus and maximum mouth opening (mm) 7. Nerve block procedure time (seconds) 8. Incidence of vascular puncture 9. Incidence and severity of adverse events (CTCAE v5.0)

Primary Sponsor	none

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Clinical Research Ethics Committee, Nihon University Itabashi Hospital
Address	30-1 Oyaguchikamimachi, Itabashi-ku, Tokyo, Tokyo
Telephone	+81-3-3972-8111
E-Mail	med.itabashi.clinicalresearch@nihon-u.ac.jp
Approval Status	Approval
Date of approval	Nov. 25, 2025

Plan to share IPD	No
Plan description	none

Secondary ID(s)	なし
Issuing Authority	none

Countries of Recruitment（Except Japan）	none