Bupivacaine Liposomes or Bupivacaine for CMB on Postoperative Analgesia in Laparoscopic Hepatobiliary Pancreatic Surgery

NCT06737341 | Not Yet Recruiting Phase 4

• 1 other identifier: Tongji Hospital 20241030
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bupivacaine; Ultrasound-Guided; Analgesia, Postoperative; Opioids

Keywords

Bupivacaine Liposome; Costal Margin Block; Laparoscopic Hepatobiliary Pancreatic Surgery

Outcome Measures

Primary Outcomes (1)

• Overall Opioid Consumption

  Main outcome measure: Postoperative 72 hour intravenous patient-controlled analgesia opioid dosage.

  up to 3 days

Secondary Outcomes (3)

• Pain intensity

  up to 3 days

• Cumulative use of opioid drugs

  up to 2 days

• Other indicators

  through study completion, an average of 10 day

Study Arms (2)

bupivacaine liposomes(BL)

EXPERIMENTAL

20ml of bupivacaine liposomes + 10ml 0.75% bupivacaine hydrochloride + 20ml normal saline for ultrasound-guided bilateral costal margin block. Block method: First, the high-frequency ultrasound probe is placed in the direction of the parasternal line parallel to the costal edge, and find the image of the costal cartilage and rectus abdominis space 。The needle was inserted along the medial side of the rectus to the lateral plane, and 15 ml of local anesthetic was injected between the costal cartilage and rectus abdominis space 。The ultrasound probe was then moved along the costal margin to the axillary front, flush with the tenth rib, and 10 ml of local anesthetic was injected in the plane between the tenth rib and the extraabdominal oblique muscle 。Similarly, perform ultrasound-guide costal rim block on the other side.

Drug: Bupivacaine Liposomes(BL)

bupivacaine(B)

ACTIVE COMPARATOR

10 ml of 0.75% bupivacaine hydrochloride + 40ml normal saline for ultrasound-guided bilateral costal margin block in the same method as the experimental group

Drug: Bupivacaine(B)

Interventions

Bupivacaine Liposomes(BL) DRUG

20ml of bupivacaine liposomes (266mg) + 10 ml of bupivacaine 0.75% hydrochloride + 20ml saline for ultrasound guided CMB.

bupivacaine liposomes(BL)

Bupivacaine(B) DRUG

10 ml of 0.75% bupivacaine hydrochloride + 40ml normal saline for ultrasound-guided bilateral costal margin block

bupivacaine(B)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old ASA Level I-III Laparoscopic Hepatobiliary Pancreatic Surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. 1095 Jiefang Avenue, Wuhan City, Hubei Province

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei Mei, MD

  Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Xu, MD

CONTACT

86-13277070358; 65022661@qq.com

Wei Mei., MD

CONTACT

86-027-83665481

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,Department of Anesthesiology, Tongji Hospital, Tongji Medical College, HUST

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 17, 2024
• Study Start: October 8, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From February 1,2025 to February 1,2027
• Access Criteria: The IPD and any additional supporting information will be shared with qualified researchers upon request. Access will be granted for the purpose of conducting further analyses related to the outcomes of the clinical trial, such as but not limited to, pain relief, opioid analgesic consumption, and complications. Requests for access will be reviewed by the principal investigators and designated research personnel to ensure that the proposed analyses align with the objectives of the study and maintain participant confidentiality. Access to the data will be provided through a secure mechanism that safeguards the privacy and integrity of the individual participant data.

Locations

CN (1)