Comparison of anesthetic concentration and volume for pain relief after wisdom tooth extraction

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1031250596

Enrollment

Registered

2025-12-24

Start date

2025-12-24

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

Impacted wisdom tooth Impacted wisdom tooth, Third molar, Tooth extraction

Interventions

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)

D009407

Lateral pterygoid muscle block, Local anesthesia, Ultrasound-guided

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Pain intensity at rest 6 hours postoperatively, assessed using the Numerical Rating Scale (NRS 0-10)	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

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