Comparison of Nerve Block Methods for Pain Relief During Wisdom Tooth Extraction

Comparison of Ultrasound-Guided Lateral Pterygoid Muscle Block versus Combined Pterygomandibular Space Block and Maxillary Nerve Block for Postoperative Analgesia in Simultaneous Upper and Lower Third Molar Extraction: A Multicenter Randomized Assessor-Blinded Three-Arm Parallel-Group Trial (DIRECT Study) - DIRECT Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1031250595

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 third molar (wisdom tooth), Postoperative pain Impacted third molar, Postoperative pain

Interventions

Group A (Control): Local anesthesia at surgical site only Group B (Lateral pterygoid muscle group): Ultrasound-guided lateral pterygoid muscle block (0.25% levobupivacaine 10mL) Group C (Individual bl

D009407

Nerve block, Ultrasound-guided, Regional anesthesia

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years or older 2. Scheduled for simultaneous upper and lower impacted third molar extraction with ASA-PS classification 1 or 2 3. Capable of providing written informed consent and communicating in Japanese

Exclusion criteria

Exclusion criteria: 1. History of allergy to amide-type local anesthetics 2. Pregnancy or breastfeeding 3. Severe hepatic impairment (Child-Pugh class B or higher) 4. Severe renal impairment (eGFR less than 30mL/min/1.73m2) 5. Anticoagulant therapy with PT-INR greater than 1.5 6. Undergoing treatment for chronic pain 7. History of severe psychiatric disorders 8. Limited mouth opening (maximum mouth opening less than 25mm)

Design outcomes

Primary

Measure	Time frame
Pain intensity at rest at 6 hours postoperatively measured by Numerical Rating Scale (NRS 0-10)	—

Secondary

Measure	Time frame
1. Pain intensity at rest and during mouth opening at each time point (extubation, 2h, 6h, 21:00, 7:00 next morning, 10:00 next morning, 24h postoperatively) measured by NRS 2. Time to first rescue analgesic administration 3. Total analgesic consumption within 24 hours postoperatively 4. Number of rescue analgesic doses 5. Incidence of postoperative nausea and vomiting (PONV) 6. Presence of trismus and maximum mouth opening 7. Nerve block procedure time 8. Incidence of vascular puncture	—

Measure

Time frame

1. Pain intensity at rest and during mouth opening at each time point (extubation, 2h, 6h, 21:00, 7:00 next morning, 10:00 next morning, 24h postoperatively) measured by NRS 2. Time to first rescue analgesic administration 3. Total analgesic consumption within 24 hours postoperatively 4. Number of rescue analgesic doses 5. Incidence of postoperative nausea and vomiting (PONV) 6. Presence of trismus and maximum mouth opening 7. Nerve block procedure time 8. Incidence of vascular puncture

—

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