BupivacainePhase 4NCT06737341
Bupivacaine Liposomes or Bupivacaine for CMB on Postoperative Analgesia in Laparoscopic Hepatobiliary Pancreatic Surgery
A Phase 4 study testing Bupivacaine Liposomes(BL) and Bupivacaine(B) in people with Bupivacaine and Ultrasound-Guided, run by Huazhong University of Science and Technology at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bupivacaine, Ultrasound-Guided, Analgesia, Postoperative
- What is being tested?
- Bupivacaine Liposomes(BL) and Bupivacaine(B)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 8 Oct 2025to 1 Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old ASA Level I-III Laparoscopic Hepatobiliary Pancreatic Surgery
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Wei Mei., MD contact
China2 sites, 2 recruiting
- Not yet recruiting
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. 1095 Jiefang Avenue, Wuhan City, Hubei Province
Wuhan, Hubei, 430030
Li Xu, MD, 86-027-83663173, 65022661@qq.com
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Li Xu, +862783663173, li_xu717@hust.edu.cn
About this study
Official 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
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.
Read the 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.
- Conditions
- Bupivacaine, Ultrasound-Guided, Analgesia, Postoperative, Opioids
- Being tested
- Bupivacaine Liposomes(BL), Bupivacaine(B)
- Keywords
- Bupivacaine Liposome, Costal Margin Block, Laparoscopic Hepatobiliary Pancreatic Surgery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Bupivacaine(B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Opioid Consumption
Main outcome measure: Postoperative 72 hour intravenous patient-controlled analgesia opioid dosage.
Measured: up to 3 days
Secondary outcomes (3)
Pain intensity
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
Measured: up to 3 days
Cumulative use of opioid drugs
Cumulative use of opioid drugs for 24-48 hour intravenous patient-controlled analgesia
Measured: up to 2 days
Other indicators
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.
Measured: through study completion, an average of 10 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start8 Oct 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BupivacaineStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Mei, Huazhong University of Science and Technology
- Investigators
- Wei Mei, MD, Principal investigator, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737341
- Sponsor's protocol ID
- Tongji Hospital 20241030
- Status last verified
- Oct 2025
- First submitted
- 9 Dec 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: individual participant data sets to be shared will include all collected individual participant data that underlie the results reported in any publications resulting from the trial. This would typically include data related to pain relief, opioid analgesic consumption, incidence of complications, and any other relevant outcomes assessed at multiple time points within 72 hours after surgery.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06737341
- Acronym / sponsor ID
- Tongji Hospital 20241030
- Conditions
- Bupivacaine, Ultrasound-Guided, Analgesia, Postoperative, Opioids
- Keywords
- Bupivacaine Liposome, Costal Margin Block, Laparoscopic Hepatobiliary Pancreatic Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bupivacaine liposomes(BL) | Experimental | Drug: 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) | Active comparator | Drug: 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-80 years old ASA Level I-III Laparoscopic Hepatobiliary Pancreatic Surgery
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine Liposomes(BL)20ml of bupivacaine liposomes (266mg) + 10 ml of bupivacaine 0.75% hydrochloride + 20ml saline for ultrasound guided CMB. | Drug | bupivacaine liposomes(BL) |
| Bupivacaine(B)10 ml of 0.75% bupivacaine hydrochloride + 40ml normal saline for ultrasound-guided bilateral costal margin block | Drug | bupivacaine(B) |
Primary outcome
Overall Opioid Consumption
Time frame: up to 3 days
Main outcome measure: Postoperative 72 hour intravenous patient-controlled analgesia opioid dosage.
3 secondary outcomes
Pain intensity
Time frame: up to 3 days
Cumulative use of opioid drugs
Time frame: up to 2 days
Other indicators
Time frame: through study completion, an average of 10 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Yes. individual participant data sets to be shared will include all collected individual participant data that underlie the results reported in any publications resulting from the trial. This would typically include data related to pain relief, opioid analgesic consumption, incidence of complications, and any other relevant outcomes assessed at multiple time points within 72 hours after surgery.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Mei., MD contact
Wei Mei, MD principal investigator
Tongji Medical College, Huazhong University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine Liposomes(BL) and Bupivacaine(B) in people with Bupivacaine and Ultrasound-Guided, run by Huazhong University of Science and Technology at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Xu, MD (86-13277070358, 65022661@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Opioid Consumption (time frame: up to 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.