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NCT Number: NCT06737341

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine Liposomes(BL)

Drug

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

Bupivacaine(B)

Drug

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

Primary outcomes

  1. Overall Opioid Consumption

    Time frame: up to 3 days

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

Secondary outcomes

  1. Pain intensity

    Time frame: 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

  2. Cumulative use of opioid drugs

    Time frame: up to 2 days

    Cumulative use of opioid drugs for 24-48 hour intravenous patient-controlled analgesia

  3. Other indicators

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Li Xu, MD

CONTACT

[email protected]

86-13277070358

Wei Mei., MD

CONTACT

86-027-83665481

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

Effect of Bupivacaine Liposomes or Bupivacaine for Ultrasound-guided CMB on Postoperative Analgesia in Laparoscopic Hepatobiliary Pancreatic Surgery: a Prospective, Single Blind, Completely Randomized, Active Controlled Clinical Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 17, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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