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

Phase 4

Not yet recruiting

• Conditions: Bupivacaine; Ultrasound-Guided; Analgesia, Postoperative; Opioids
• Interventions: Drug: Bupivacaine Liposomes(BL); Drug: Bupivacaine(B)

• Registration Number: NCT06737341
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

All participators were randomized into two groups using a complete randomization allocation method: the trial group and the control group. An investigator introduced the study to the study before surgery and informed consent was obtained. The investigators educate patients on how to use the VAS scale to express pain intensity and instruct patients on how to use the postoperative analgesia pump. General anesthesia with endotracheal intubation or laryngeal mask before the nerve block. Standard analgesic protocol: sufentanil (0.5 μg/ kg) + remifentanil (0.1-0.2 μg / kg/min) + flurbiprofen ester (50mg); intravenous analgesia pump (PCIA) or analgesic with opioids and non-steroidal anti-inflammatory drugs as needed. All patients underwent ultrasound-guided bilateral costal margin block (CMB). Test group: 20ml bupivacaine liposomes +10ml 0.75% bupivacaine hydrochloride + 20ml normal saline, for ultrasound-guided CMB. Control group: 10 ml of 0.75% bupivacaine hydrochloride + 40ml of normal saline, with ultrasound-guided CMB.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-15
• Last Update Submitted: 2024-12-15
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Study Start: 2025-02-01
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine liposomes(BL)	Bupivacaine Liposomes(BL)	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.
bupivacaine(B)	Bupivacaine(B)	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

Primary Outcome Measures

Name	Time	Method
Overall Opioid Consumption	up to 3 days	Main outcome measure: Postoperative 72 hour intravenous patient-controlled analgesia opioid dosage.

Secondary Outcome Measures

Name	Time	Method
Pain intensity	up to 3 days	Pain intensity will be assessed using the Numerical Rating Scale (NRS), a 0-10 scale where 0 represents no pain and 10 represents the worst imaginable pain. Pain intensity will be measured during rest (supine position) and activity (shifting from supine position to lateral position) at 5 time points: at Post Anesthesia Care Unit(PACU), 6 hours, 24 hours, 48 hours，and 72 hours post-surgery
Cumulative use of opioid drugs	up to 2 days	Cumulative use of opioid drugs for 24-48 hour intravenous patient-controlled analgesia
Other indicators	through study completion, an average of 10 day	The incidence of postoperative pulmonary complications (including pneumonia, hypoxemia, and atelectasis), postoperative sleep quality (Pittsburgh Sleep Quality Scale), patient satisfaction with postoperative analgesic treatment (0-10 scale, 0 for very dissatisfied, 10 for very satisfied), time of first ambulation after surgery, time of first anal exhaust after surgery, length of hospital stay, and adverse events such as opioid related dizziness, nausea, and vomiting, as well as block related complications.

Trial Locations

Locations (1)

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