NCT06565910 Bupivacaine Liposome Plus Bupivacaine or Ropivacaine for Pericapsular Nerve Group Block in Hip Arthroplasty (PENG)
| NCT ID | NCT06565910 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Huazhong University of Science and Technology |
| Condition | Femoral Neck Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-12-04 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2024-12-04 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to study the analgesic effect of liposomal bupivacaine plus bupivacaine for Pericapsular Nerve Group (PENG) block in postoperative pain management following hip replacement surgery. It will also assess the safety of liposomal bupivacaine for this purpose. The main questions it aims to answer are: 1. Is liposomal bupivacaine plus bupivacaine superior to ropivacaine in terms of analgesic efficacy, duration of pain relief, opioid consumption, and patient satisfaction? 2. What medical problems do participants encounter when using liposomal bupivacaine plus bupivacaine for PENG block in postoperative pain management following hip replacement surgery? Researchers will compare liposomal bupivacaine plus bupivacaine to ropivacaine (a routinely used regional anesthetic in clinical practice) to determine if liposomal bupivacaine plus bupivacaine is more effective for pain management following hip replacement surgery. Participants will: 1. Receive liposomal bupivacaine plus bupivacaine or ropivacaine as a regional anesthetic for PENG block under ultrasound guidance. 2. Undergo hip replacement surgery under spinal anesthesia. 3. Have pain relief, opioid analgesic consumption, and incidence of complications assessed at multiple time points within 72 hours after surgery.
Eligibility Criteria
Inclusion Criteria: * American Society of Anesthesiologists(ASA) I\~II * Normal coagulation * Clinical diagnosis of hip fracture Exclusion Criteria: * Presence of severe systemic diseases or ASA grade III or higher * Allergy to amide local anesthetics
Contact & Investigator
Wei Mei, MD
STUDY DIRECTOR
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, HUST
Frequently Asked Questions
Who can join the NCT06565910 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Femoral Neck Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06565910 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06565910 currently recruiting?
Yes, NCT06565910 is actively recruiting participants. Contact the research team at kexijian@hust.edu.cn for enrollment information.
Where is the NCT06565910 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06565910 clinical trial?
NCT06565910 is sponsored by Huazhong University of Science and Technology. The principal investigator is Wei Mei, MD at Department of Anesthesiology, Tongji Hospital, Tongji Medical College, HUST. The trial plans to enroll 60 participants.