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Comparison of the effects of different volumes of ropivacaine for ultrasound-guided trigeminal nerve block in bimaxillary orthognathic surgery: A Single-Center, Randomized, Parallel-controlled, Double-Blind, Non-inferiority Trial

Comparison of the effects of different volumes of ropivacaine for ultrasound-guided trigeminal nerve block in bimaxillary orthognathic surgery: A Single-Center, Randomized, Parallel-controlled, Double-Blind, Non-inferiority Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081389
Enrollment
Unknown
Registered
2024-02-29
Start date
2024-05-17
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postoperative pain

Interventions

low-volume group :ultrasound-guided bilateral trigeminal nerve block with 0.375% ropivacaine 2 mL (each side)
high-volume group :ultrasound-guided bilateral trigeminal nerve block with 0.375% ropivacaine 5 mL (each side)

Sponsors

West China Hospital of Stomatology, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-45 years old. 2. No gender limitation. 3. BMI 18-30 kg/m2. 4. American Society of Anesthesiologists (ASA) physical status classification I–II. 5. Patients undergoing elective bimaxillary orthognathic surgery under general anesthesia.

Exclusion criteria

Exclusion criteria: 1. temporomandibular joint surgery is also required. 2. have any contraindications for controlled hypotension. 3. an established mental illness. 4. inability to communicate due to visual, hearing, speech, or other impairments. 5. Patients with a history of chronic pain or opioid abuse before surgery. 6. allergic to the drug components or ingredients used in this study. 7. have any contraindications for nerve block, including coagulation disorders, infection in the block site, any puncture route related anatomical abnormalities. 8. history of severe bradycardia (heart rate =50 beats per minute); different types of sinoatrial block, Intra-atrial block and intraventricular block; history of morbid sinus node syndrome or pre-excitation syndromes, etc. 9. submental endotracheal intubation was planned rather than transnasal tracheal intubation.

Design outcomes

Primary

MeasureTime frame
Postoperative visual analogue scale pain score in maxilla;

Secondary

MeasureTime frame
Postoperative pain assessed at different surgical site;intraoperative hemodynamic changes ;Intraoperative consumption of opioids, sedatives, and vasoactive medication;The use of remedial analgesics within 48h after surgery;the time to first request of analgesia;Postoperative quality of recovery score, QoR-15;nausea;vomiting;Perioperative complications;

Countries

China

Contacts

Public ContactYang Ji

West China Hospital of Stomatology, Sichuan University

yangji7799@163.com+86 136 6626 4254

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026