Liver CancerPhase 4NCT06173466
Postoperative Analgesia With Liposomal Bupivacaine Versus Standard Bupivacaine Combined With Dexamethasone
A Phase 4 study testing Liposomal bupivacaine and Bupivacaine Hydrochloride combined with dexamethasone in people with Liver Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Liposomal bupivacaine is a novel long-acting local anesthetic approved by the FDA for postoperative analgesia because of its ability to significantly prolong the analgesic effect for up to 72 hours. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Liposomal bupivacaine and Bupivacaine Hydrochloride combined with dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2023to 30 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old;
- American Society of Anesthesiologist physical status I-III;
- Child-Pugh score A-B;
- Non anergic to medication used in this study;
- Optional/scheduled for liver resection;
- Approved participation before study.
Who cannot join
- Patients with contraindications for local nerve block such as spinal anatomic structure abnormality or local infection of puncture area;
- Anergic to medications used in this study;
- Patient have chronic pain;
- Patient receiving anticoagulants, opioids or have a history of narcotic abuse or alcohol abuse;
- Unable to complete postoperative pain score assessment or questionnaires or have mental disorders;
- Pregnant;
- BMI ≥30 kg/m2;
- Patient involving in other studies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thoracic Paravertebral Block With Liposomal Bupivacaine Versus Standard Bupivacaine Combined With Dexamethasone for Postoperative Analgesia in Patients Undergoing Liver Resection
Liposomal bupivacaine is a novel long-acting local anesthetic approved by the FDA for postoperative analgesia because of its ability to significantly prolong the analgesic effect for up to 72 hours. Up to now, no study has demonstrated the effect of postoperative analgesia with liposomal bupivacaine by thoracic paravertebral block (TPVB). The aim of this study was to evaluate the efficacy of liposomal bupivacaine for pain management and recovery after liver resection.
Methods: 96 patients were involved in this randomized, prospective, single-blind study. Patients with hepatocellular carcinoma who were undergoing liver resection were divided into two groups: liposome bupivacaine group (liposomal bupivacaine 133mg) and standard bupivacaine combined with dexamethasone group (standard bupivacaine 150mg and dexamethasone 5mg). Both groups were applied ultrasound guided TPVB. The primary outcome was the cumulative opioid consumptionfor 72 hours. Secodary outcomes included QoR-40 at 72 hours, pain visual analog scale (VAS) score area under the curve (AUC) from 6 hours to 3 months, sleep quality at 1 month and 3 months postoperatively. Adverse events and serious adverse events 3 months after TPVB were also recorded.
Read the detailed description
After approved by the Ethics Committee of Zhejiang Cancer Hospital (approval number IRB-2023-941 (IIT)). The study was registered before patient enrollment in Clinicaltrials. Written informed consent was obtained from all participants. The study was performed anticipated from November 9, 2023 to Dec 31, 2025. 96 adult hepatocellular carcinoma patients aged 18-75 years, ASA physical state I and III, who underwent elective or limited partial hepatectomy without allergy to the study drugs were enrolled in this study.
Basic monitoring such as 3-lead electrocardiogram, pulse oximetry, and noninvasive blood pressure were arranged preoperatively. Patients in the bupivacaine liposome group were treated with liposome bupivacaine 133 mg, and patients in the standard control group were treated with 0.5% bupivacaine hydrochloride 150 mg combined with dexamethasone 4 mg, the volume were expended to 30ml in both groups with normal saline. And ultrasound-guided TPVB was performed at the right T7-8, T8-9, T9-10, and T10-11 paravertebral interval under left lateral decubitus position, with 7.5 ml of medication injected into each paravertebral interval, for a total of 30 ml. Patient-controlled intravenous analgesia (PCIA) was used for postoperative analgesia, with 100mg oxycodone expended to 100ml with normal saline, 6-7ml per press with locked time of 15min and limited consumption of 12-15mg each hour based on the weight and basic situation of patient. Rescue analgesia was administered with flurbiprofenate 50 mg or tramadol 100 mg every 6 h when rest VAS score was ≥4. Cumulative consumption of 72 hours postoperatively was recorded. Quality of recovery 40 (QoR-40) score of 72 hours, pain visual analog (VAS) score from 6 hours to 3 months and sleep quality from discharge to 3 months after surgery were also recorded.
- Conditions
- Liver Cancer
- Being tested
- Liposomal bupivacaine, Bupivacaine Hydrochloride combined with dexamethasone
- Keywords
- Liver Resection, Thoracic Paravertebral Block, Liposomal Bupivacaine
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called LB group (experimental group)
Liposomal bupivacaine 133mg was injected to paravertebral intervals of right T7/8, T8/9, T9//10, T10/11 via ultrasound-guided TPVB
Bupivacaine Hydrochloride combined with dexamethasoneDrug
Also called SB Group (control group)
Standard bupivacaine combined with dexamethasone 4mg was injected to paravertebral intervals of right T7/8, T8/9, T9//10, T10/11 via ultrasound-guided TPVB
| Study group | Role | What they receive |
|---|---|---|
| Liposomal bupivacaine | Experimental | Patients in the bupivacaine liposomal group were treated with liposome bupivacaine 133 mg under ultrasound-guided TPVB. And ultrasound-guided TPVB was performed at the right T7-8, T8-9, T9-10, and T10-11 paravertebral interval under left lateral decubitus position, with 7.5 ml of medication injected into each paravertebral interval, for a total of 30 ml. Receives: Drug: Liposomal bupivacaine |
| Standard bupivacaine combined with dexamethasone | Active comparator | Patients in the standard control group were treated with 0.5% bupivacaine hydrochloride 150 mg combined with dexamethasone 4 mg. the volume were expended to 30ml in both groups with normal saline. And ultrasound-guided TPVB was performed at the right T7-8, T8-9, T9-10, and T10-11 paravertebral interval under left lateral decubitus position, with 7.5 ml of medication injected into each paravertebral interval, for a total of 30 ml. Receives: Drug: Bupivacaine Hydrochloride combined with dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative opioid consumption of 72 hours after surgery
Cumulative opioid consumption of 72 hours after surgery were recorded.
Measured: From discharge from post anesthesia care unit (PACU) to 72 hours postoperatively.
Secondary outcomes (6)
Quality of recovery 40 (QoR-40) scores of 72 hours
Quality of recovery 40 (QoR-40) scores of 72 hours were recorded. In specific, QoR-40, a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is graded on a five-point Likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
Measured: From discharge from PACU to 72 hours postoperatively.
Pain visual analog (VAS) scores from 6 hours to 3 months
Pain visual analog (VAS) scores from 6 hours to 3 months were recorded. With a scale between 0 to 10, and the pain intensity increases as the number grows. In which 0 represent no pain and 10 represent worst pain.
Measured: From 6 hours to 3 months after surgery.
Sleep quality
Sleep quality up to 3 months were recorded. Pittsburgh Sleep Quality Index (PSQI) to assess sleep quality. The PSQI is a validated, self-administered questionnaire used to generate seven component scores calculated by 19 items which reflect subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime function. articipants with poor sleep quality are defined as those with a sum of the scores greater than 5 for these seven components.
Measured: 3 months after surgery.
Time to first opioid use
Time to first opioid use was recorded in each group from discharge from PACU to 72 hours after surgery.
Measured: An average time is 2-3 hours after discharge from PACU.
Plasma bupivacaine concentration
Measure plasma bupivacaine concentration after administration of local anesthetics.
Measured: From 30 minutes after local anesthetics administration to 72 hour after surgery.
Postoperative plasma inflammatory factors
Measure postoperative plasma inflammatory factors (IL-6, IL-8, TNF-a) before administration of local anesthetics and after surgery.
Measured: From administration of local anesthesics to 72 hour after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start15 Dec 2023
- Primary completion28 Feb 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Jiangling, Zhejiang Cancer Hospital
- Investigators
- Jiangling Wang, Ph. D, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173466
- Sponsor's protocol ID
- IRB-2023-941 (IIT)
- Status last verified
- Jun 2025
- First submitted
- 30 Nov 2023
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Paravertebral Block With Liposomal Bupivacaine Versus Standard Bupivacaine Combined With Dexamethasone for Postoperative Analgesia in Patients Undergoing Liver Resection
- ClinicalTrials.gov ID
- NCT06173466
- Acronym / sponsor ID
- IRB-2023-941 (IIT)
- Conditions
- Liver Cancer
- Keywords
- Liver Resection, Thoracic Paravertebral Block, Liposomal Bupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 15 Dec 2023 (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.
Liposomal bupivacaine is a novel long-acting local anesthetic approved by the FDA for postoperative analgesia because of its ability to significantly prolong the analgesic effect for up to 72 hours. Up to now, no study has demonstrated the effect of postoperative analgesia with liposomal bupivacaine by thoracic paravertebral block (TPVB). The aim of this study was to evaluate the efficacy of liposomal bupivacaine for pain management and recovery after liver resection.
Methods: 96 patients were involved in this randomized, prospective, single-blind study. Patients with hepatocellular carcinoma who were undergoing liver resection were divided into two groups: liposome bupivacaine group (liposomal bupivacaine 133mg) and standard bupivacaine combined with dexamethasone group (standard bupivacaine 150mg and dexamethasone 5mg). Both groups were applied ultrasound guided TPVB. The primary outcome was the cumulative opioid consumptionfor 72 hours. Secodary outcomes included QoR-40 at 72 hours, pain visual analog scale (VAS) score area under the curve (AUC) from 6 hours to 3 months, sleep quality at 1 month and 3 months postoperatively. Adverse events and serious adverse events 3 months after TPVB were also recorded.
Detailed description
After approved by the Ethics Committee of Zhejiang Cancer Hospital (approval number IRB-2023-941 (IIT)). The study was registered before patient enrollment in Clinicaltrials. Written informed consent was obtained from all participants. The study was performed anticipated from November 9, 2023 to Dec 31, 2025. 96 adult hepatocellular carcinoma patients aged 18-75 years, ASA physical state I and III, who underwent elective or limited partial hepatectomy without allergy to the study drugs were enrolled in this study.
Basic monitoring such as 3-lead electrocardiogram, pulse oximetry, and noninvasive blood pressure were arranged preoperatively. Patients in the bupivacaine liposome group were treated with liposome bupivacaine 133 mg, and patients in the standard control group were treated with 0.5% bupivacaine hydrochloride 150 mg combined with dexamethasone 4 mg, the volume were expended to 30ml in both groups with normal saline. And ultrasound-guided TPVB was performed at the right T7-8, T8-9, T9-10, and T10-11 paravertebral interval under left lateral decubitus position, with 7.5 ml of medication injected into each paravertebral interval, for a total of 30 ml. Patient-controlled intravenous analgesia (PCIA) was used for postoperative analgesia, with 100mg oxycodone expended to 100ml with normal saline, 6-7ml per press with locked time of 15min and limited consumption of 12-15mg each hour based on the weight and basic situation of patient. Rescue analgesia was administered with flurbiprofenate 50 mg or tramadol 100 mg every 6 h when rest VAS score was ≥4. Cumulative consumption of 72 hours postoperatively was recorded. Quality of recovery 40 (QoR-40) score of 72 hours, pain visual analog (VAS) score from 6 hours to 3 months and sleep quality from discharge to 3 months after surgery were also recorded.
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 |
|---|---|---|
| Liposomal bupivacaine | Experimental | Drug: Liposomal bupivacainePatients in the bupivacaine liposomal group were treated with liposome bupivacaine 133 mg under ultrasound-guided TPVB. And ultrasound-guided TPVB was performed at the right T7-8, T8-9, T9-10, and T10-11 paravertebral interval under left lateral decubitus position, with 7.5 ml of medication injected into each paravertebral interval, for a total of 30 ml. |
| Standard bupivacaine combined with dexamethasone | Active comparator | Drug: Bupivacaine Hydrochloride combined with dexamethasonePatients in the standard control group were treated with 0.5% bupivacaine hydrochloride 150 mg combined with dexamethasone 4 mg. the volume were expended to 30ml in both groups with normal saline. And ultrasound-guided TPVB was performed at the right T7-8, T8-9, T9-10, and T10-11 paravertebral interval under left lateral decubitus position, with 7.5 ml of medication injected into each paravertebral interval, for a total of 30 ml. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-75 years old;
- American Society of Anesthesiologist physical status I-III;
- Child-Pugh score A-B;
- Non anergic to medication used in this study;
- Optional/scheduled for liver resection;
Key exclusion criteria (8 listed)
- Patients with contraindications for local nerve block such as spinal anatomic structure abnormality or local infection of puncture area;
- Anergic to medications used in this study;
- Patient have chronic pain;
- Patient receiving anticoagulants, opioids or have a history of narcotic abuse or alcohol abuse;
- Unable to complete postoperative pain score assessment or questionnaires or have mental disorders;
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 |
|---|---|---|
| Liposomal bupivacaineAlso: LB group (experimental group)Liposomal bupivacaine 133mg was injected to paravertebral intervals of right T7/8, T8/9, T9//10, T10/11 via ultrasound-guided TPVB | Drug | Liposomal bupivacaine |
| Bupivacaine Hydrochloride combined with dexamethasoneAlso: SB Group (control group)Standard bupivacaine combined with dexamethasone 4mg was injected to paravertebral intervals of right T7/8, T8/9, T9//10, T10/11 via ultrasound-guided TPVB | Drug | Standard bupivacaine combined with dexamethasone |
Primary outcome
Cumulative opioid consumption of 72 hours after surgery
Time frame: From discharge from post anesthesia care unit (PACU) to 72 hours postoperatively.
Cumulative opioid consumption of 72 hours after surgery were recorded.
6 secondary outcomes
Quality of recovery 40 (QoR-40) scores of 72 hours
Time frame: From discharge from PACU to 72 hours postoperatively.
Pain visual analog (VAS) scores from 6 hours to 3 months
Time frame: From 6 hours to 3 months after surgery.
Sleep quality
Time frame: 3 months after surgery.
Time to first opioid use
Time frame: An average time is 2-3 hours after discharge from PACU.
Plasma bupivacaine concentration
Time frame: From 30 minutes after local anesthetics administration to 72 hour after surgery.
Postoperative plasma inflammatory factors
Time frame: From administration of local anesthesics to 72 hour after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jiangling Wang, Ph. D principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal bupivacaine and Bupivacaine Hydrochloride combined with dexamethasone in people with Liver Cancer, run by Zhejiang Cancer Hospital at 1 site 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative opioid consumption of 72 hours after surgery (time frame: From discharge from post anesthesia care unit (PACU) to 72 hours postoperatively.). 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 26 Jun 2025.