NCT06737341 Bupivacaine Liposomes or Bupivacaine for CMB on Postoperative Analgesia in Laparoscopic Hepatobiliary Pancreatic Surgery
| NCT ID | NCT06737341 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Huazhong University of Science and Technology |
| Condition | Bupivacaine |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-10-08 |
| Primary Completion | 2027-02-01 |
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 2025-10-08 with a primary completion date of 2027-02-01.
⚠ 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
Numerous studies have confirmed that regional analgesia using peripheral nerve block has great potential for perioperative analgesia in abdominal surgery. Ultrasound guided costal margin block (CMB) is a new regional anesthesia technique that has been proven to compensate for the analgesic effects of regional analgesia techniques such as transverse abdominal muscle plane (TAP) and rectus abdominis sheath (RSB) on mid abdominal incisions, but it is difficult to meet the analgesic needs of anterior and outer abdominal wall incisions. According to relevant anatomy and research, the application of local anesthetics along the rib margin under the rectus abdominis muscle or under the external oblique muscle on the rib surface can block the lateral and anterior cutaneous branches of the thoracoabdominal nerve, known as CMB. Ultrasound guided CMB requires the injection of local anesthetics onto the surface of the rib along the plane below the rectus abdominis and oblique muscles, covering most of the upper abdominal incision pain. However, there are few reports on other types of upper abdominal surgeries such as liver, gallbladder, and pancreas surgeries. Bupivacaine liposomes are an important innovation, which encapsulate bupivacaine in polycystic liposomes using DepoFoam technology to achieve slow drug release and effectively prolong pain relief time by up to 72 hours. This ultra long acting local anesthetic has significant advantages in reducing opioid use, improving analgesic satisfaction, reducing complications, and shortening hospital stays, and has been applied in the ERAS concept. The investigators designed a prospective, single blind, randomized, active controlled clinical trial to investigate the effect of bupivacaine liposomes in combination with bupivacaine mixture or bupivacaine alone for ultrasound-guided bilateral CMB on postoperative analgesia in patients undergoing laparoscopic hepatobiliary pancreatic surgery. Our main hypothesis is that the use of bupivacaine liposomes and a mixture of bupivacaine for ultrasound-guided CMB in a multimodal analgesia regimen can more effectively reduce the dosage of intravenous patient-controlled analgesia (PCA) opiates within 72 hours after laparoscopic hepatobiliary pancreatic surgery compared to using bupivacaine alone. Secondary outcomes include the dosage of PCA opiates within 24-48 hours, pain score values, patient satisfaction, adverse reactions, and complications.
Eligibility Criteria
Inclusion Criteria: * 18-80 years old ASA Level I-III Laparoscopic Hepatobiliary Pancreatic Surgery Exclusion Criteria: * Body Mass Index (BMI) ≥ 30 kg/m ² or ≤ 15 kg/m ² Known alcohol or drug abuse History of upper abdominal surgery Congenital coagulation dysfunction Localized or systemic infection Peripheral neuropathy Unable to understand the research plan
Contact & Investigator
Wei Mei, MD
PRINCIPAL INVESTIGATOR
Tongji Medical College, Huazhong University of Science and Technology
Frequently Asked Questions
Who can join the NCT06737341 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Bupivacaine. 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 NCT06737341 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 NCT06737341 currently recruiting?
Yes, NCT06737341 is actively recruiting participants. Contact the research team at 65022661@qq.com for enrollment information.
Where is the NCT06737341 trial being conducted?
This trial is being conducted at Wuhan, China, Wuhan, China.
Who is sponsoring the NCT06737341 clinical trial?
NCT06737341 is sponsored by Huazhong University of Science and Technology. The principal investigator is Wei Mei, MD at Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 60 participants.