Postoperative Pain, AcuteNCT07134660
Thoracic Surgery Intercostal Block Trial With Liposomal vs. Hydrochloride Bupivacaine
A study testing Liposomal Bupivacaine intercostal nerve block, Bupivacaine Hydrochloride intercostal nerve block and Standard Postoperative Analgesia in people with Postoperative Pain, Acute and Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
This randomized controlled trial evaluates the analgesic effects of liposomal bupivacaine compared to bupivacaine hydrochloride in intercostal nerve block for patients undergoing thoracoscopic lung surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain, Acute, Lung Cancer
- What is being tested?
- Liposomal Bupivacaine intercostal nerve block, Bupivacaine Hydrochloride intercostal nerve block and Standard Postoperative Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 20 Sep 2026
- Phase
- Interventional
- 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
- Scheduled for elective unilateral thoracoscopic (VATS) lung surgery
- Age 18 to 80 years
- American Society of Anesthesiologists (ASA) physical status I-III
Who cannot join
- Contraindication to local anesthetics (infection at puncture site, allergy to local anesthetics, coagulopathy or other bleeding risk)
- Sensory abnormalities in the planned chest-wall surgical area
- Hepatic dysfunction (ALT > 50 U/L, AST > 40 U/L, or total bilirubin ≥ 19 μmol/L) or renal dysfunction (serum creatinine > 112 μmol/L, BUN > 7.1 mmol/L, or dialysis within 28 days before surgery)
- Pregnancy, breastfeeding, women of childbearing potential not using adequate contraception, or planning pregnancy during the study period
- Preoperative opioid use, history of chronic pain, or history of opioid abuse
- Refusal to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai pulmonary hospital
Shanghai
Shiyou Wei, 15601680099, lovewishyou@tongji.edu.cn
Lv, 13661869919, xinlvg@126.com
About this study
Official title: Analgesic Efficacy Between Liposomal Bupivacaine and Bupivacaine Hydrochloride in Intercostal Nerve Block for Thoracic Surgery: A Multicenter Randomized Controlled Trial
This randomized controlled trial evaluates the analgesic effects of liposomal bupivacaine compared to bupivacaine hydrochloride in intercostal nerve block for patients undergoing thoracoscopic lung surgery. Postoperative pain remains a significant issue in thoracic procedures, often leading to complications like pneumonia or delayed recovery. The investigators hypothesize that liposomal bupivacaine, with its extended-release properties, will provide superior pain relief beyond 24 hours compared to standard bupivacaine or no block. Participants will be randomized 1:1:1 to liposomal bupivacaine group , bupivacaine hydrochloride group , or control group . Primary outcome is the area under the curve of pain scores from 25-72 hours post-surgery. Secondary outcomes include opioid consumption, recovery quality (QoR-15), and other complications.
Read the detailed description
Background: Lung cancer surgery, even with minimally invasive thoracoscopy, causes significant postoperative pain in up to 62.9% of patients, potentially leading to complications and chronic pain. Intercostal nerve block is a safe alternative to epidural analgesia, but standard local anesthetics like bupivacaine provide limited duration (<8 hours). Liposomal bupivacaineoffers prolonged release up to 72 hours.
Objective: To compare the analgesic efficacy of liposomal bupivacaine versus bupivacaine hydrochloride in intercostal nerve block, assessing pain scores, opioid use, recovery quality, and complications in thoracoscopic lung surgery patients.
Design: Multicenter, randomized controlled trial with 210 participants (70 per group). Randomization with (1:1:1).
Methods: Eligible patients receive ultrasound-guided intercostal block post-surgery: Liposomal bupivacaine (20 mL, 266 mg), bupivacaine HCl (20 mL, 0.25%), or control (IV PCA only). Follow-up includes pain scores, opioid consumption, QoR-15, and adverse events up to 72 hours.
Expected Outcomes: Liposomal bupivacaine expected to reduce pain AUC by >10% vs. bupivacaine and >15% vs. control from 25-72 hours.
- Conditions
- Postoperative Pain, Acute, Lung Cancer
- Being tested
- Liposomal Bupivacaine intercostal nerve block, Bupivacaine Hydrochloride intercostal nerve block, Standard Postoperative Analgesia
- Keywords
- Postoperative Pain, Intercostal Nerve Block, Liposomal Bupivacaine
- Medical subject headings
- Pain, Postoperative, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Bupivacaine intercostal nerve blockProcedure or surgery
Ultrasound-guided intercostal nerve block with liposomal bupivacaine 266 mg (20 mL total; 4 mL per intercostal space at the incision and adjacent spaces), performed at the end of surgery before emergence from anesthesia. All patients receive standard postoperative analgesia with intravenous patient-controlled opioid analgesia.
Bupivacaine Hydrochloride intercostal nerve blockProcedure or surgery
Ultrasound-guided intercostal nerve block with 0.25% bupivacaine hydrochloride (20 mL total; 4 mL per intercostal space at the incision and adjacent spaces), performed at the end of surgery before emergence from anesthesia. All patients receive standard postoperative analgesia with intravenous patient-controlled opioid analgesia.
Standard Postoperative AnalgesiaOther
No intercostal nerve block. Patients receive standard postoperative analgesia consisting of an intravenous patient-controlled opioid pump per institutional protocol.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine Group | Experimental | Ultrasound-guided intercostal nerve block performed at the end of surgery before emergence from anesthesia using liposomal bupivacaine 266 mg (20 mL). Patients also receive standard postoperative analgesia with IV PCA (patient-controlled analgesia) opioids and regular acetaminophen Receives: Procedure: Liposomal Bupivacaine intercostal nerve block |
| Bupivacaine Hydrochloride Group | Active comparator | Ultrasound-guided intercostal nerve block performed at the end of surgery before emergence from anesthesia using 0.25% bupivacaine hydrochloride (20 mL). Patients also receive standard postoperative analgesia with IV PCA opioids and regular acetaminophen Receives: Procedure: Bupivacaine Hydrochloride intercostal nerve block |
| Control Group (Standard Analgesia Only) | Sham comparator | No intercostal nerve block, just wait same time. Patients receive standard postoperative analgesia consisting of IV PCA opioids and regular acetaminophen, beginning immediately after surgery. Receives: Other: Standard Postoperative Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score area under the curve (AUC) from 25 to 72 hours postoperatively
Area under the curve of postoperative pain intensity measured on the VRS. AUC is computed over the 25-72 h interval. Postoperative pain intensity assessed using the Verbal Response Scale (VRS), the score ranges from 0 to 10, with a total of 11 numbers corresponding to different pain levels: 0 indicates no pain; 1-3 indicates mild pain (tolerable and does not affect sleep); 4-6 indicates moderate pain (significant, affects sleep, and requires medication for relief); and 7-10 indicates severe pain (intense, intolerable, and severely affects life).
Measured: 25 to 72 hours after the end of surgery
Secondary outcomes (2)
Pain score at PACU discharge and postoperative intervals
Pain intensity assessed using the VRS in the post-anesthesia care unit (PACU) and at 6, 12, 24, 48, and 72 hours after surgery. Postoperative pain intensity assessed using the Verbal Response Scale (VRS), the score ranges from 0 to 10, with a total of 11 numbers corresponding to different pain levels: 0 indicates no pain; 1-3 indicates mild pain (tolerable and does not affect sleep); 4-6 indicates moderate pain (significant, affects sleep, and requires medication for relief); and 7-10 indicates severe pain (intense, intolerable, and severely affects life).Rescue analgesia is provided if VRS >4.
Measured: At PACU discharge, and 6, 12, 24, 48, and 72 hours postoperatively
Cumulative opioid consumption
Total postoperative opioid use converted to morphine milligram equivalents.
Measured: From the end of surgery to 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Sep 2025
- Primary completion15 Sep 2026 (estimated)
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiyou Wei, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Xin Y Lv, PhD, Study director, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134660
- Sponsor's protocol ID
- 2024LY0971
- Status last verified
- Mar 2026
- First submitted
- 3 Aug 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang J, Wang L, Wei S, Xin Y, Chang R, Liu H, Yang Y, Song J, Lv X. Comparison of liposomal bupivacaine and bupivacaine hydrochloride intercostal nerve blocks for postoperative analgesia after thoracic surgery: a multicenter, randomized, three arms trial protocol. Ann Med. 2026 Dec;58(1):2612384. doi: 10.1080/07853890.2025.2612384. Epub 2026 Jan 20.
PubMed 41560407Yu J, Wei S, Ling D, Xin Y, Liu H, Yang Y, Li X, Xiang Z, Liu J. Effective Dose of Oliceridine for Inhibiting Hemodynamic Elevation Induced by Tracheal Intubation: An Up-and-Down Sequential Trial. Drug Des Devel Ther. 2025 Dec 26;19:11767-11778. doi: 10.2147/DDDT.S567868. eCollection 2025.
PubMed 41477178
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy Between Liposomal Bupivacaine and Bupivacaine Hydrochloride in Intercostal Nerve Block for Thoracic Surgery: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07134660
- Acronym / sponsor ID
- 2024LY0971
- Conditions
- Postoperative Pain, Acute, Lung Cancer
- Keywords
- Postoperative Pain, Intercostal Nerve Block, Liposomal Bupivacaine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 21 Aug 2025 (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.
This randomized controlled trial evaluates the analgesic effects of liposomal bupivacaine compared to bupivacaine hydrochloride in intercostal nerve block for patients undergoing thoracoscopic lung surgery. Postoperative pain remains a significant issue in thoracic procedures, often leading to complications like pneumonia or delayed recovery. The investigators hypothesize that liposomal bupivacaine, with its extended-release properties, will provide superior pain relief beyond 24 hours compared to standard bupivacaine or no block. Participants will be randomized 1:1:1 to liposomal bupivacaine group , bupivacaine hydrochloride group , or control group . Primary outcome is the area under the curve of pain scores from 25-72 hours post-surgery. Secondary outcomes include opioid consumption, recovery quality (QoR-15), and other complications.
Detailed description
Background: Lung cancer surgery, even with minimally invasive thoracoscopy, causes significant postoperative pain in up to 62.9% of patients, potentially leading to complications and chronic pain. Intercostal nerve block is a safe alternative to epidural analgesia, but standard local anesthetics like bupivacaine provide limited duration (<8 hours). Liposomal bupivacaineoffers prolonged release up to 72 hours.
Objective: To compare the analgesic efficacy of liposomal bupivacaine versus bupivacaine hydrochloride in intercostal nerve block, assessing pain scores, opioid use, recovery quality, and complications in thoracoscopic lung surgery patients.
Design: Multicenter, randomized controlled trial with 210 participants (70 per group). Randomization with (1:1:1).
Methods: Eligible patients receive ultrasound-guided intercostal block post-surgery: Liposomal bupivacaine (20 mL, 266 mg), bupivacaine HCl (20 mL, 0.25%), or control (IV PCA only). Follow-up includes pain scores, opioid consumption, QoR-15, and adverse events up to 72 hours.
Expected Outcomes: Liposomal bupivacaine expected to reduce pain AUC by >10% vs. bupivacaine and >15% vs. control from 25-72 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine Group | Experimental | Procedure: Liposomal Bupivacaine intercostal nerve blockUltrasound-guided intercostal nerve block performed at the end of surgery before emergence from anesthesia using liposomal bupivacaine 266 mg (20 mL). Patients also receive standard postoperative analgesia with IV PCA (patient-controlled analgesia) opioids and regular acetaminophen |
| Bupivacaine Hydrochloride Group | Active comparator | Procedure: Bupivacaine Hydrochloride intercostal nerve blockUltrasound-guided intercostal nerve block performed at the end of surgery before emergence from anesthesia using 0.25% bupivacaine hydrochloride (20 mL). Patients also receive standard postoperative analgesia with IV PCA opioids and regular acetaminophen |
| Control Group (Standard Analgesia Only) | Sham comparator | Other: Standard Postoperative AnalgesiaNo intercostal nerve block, just wait same time. Patients receive standard postoperative analgesia consisting of IV PCA opioids and regular acetaminophen, beginning immediately after surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled for elective unilateral thoracoscopic (VATS) lung surgery
- Age 18 to 80 years
- American Society of Anesthesiologists (ASA) physical status I-III
Key exclusion criteria (6 listed)
- Contraindication to local anesthetics (infection at puncture site, allergy to local anesthetics, coagulopathy or other bleeding risk)
- Sensory abnormalities in the planned chest-wall surgical area
- Hepatic dysfunction (ALT > 50 U/L, AST > 40 U/L, or total bilirubin ≥ 19 μmol/L) or renal dysfunction (serum creatinine > 112 μmol/L, BUN > 7.1 mmol/L, or dialysis within 28 days before surgery)
- Pregnancy, breastfeeding, women of childbearing potential not using adequate contraception, or planning pregnancy during the study period
- Preoperative opioid use, history of chronic pain, or history of opioid abuse
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 Bupivacaine intercostal nerve blockUltrasound-guided intercostal nerve block with liposomal bupivacaine 266 mg (20 mL total; 4 mL per intercostal space at the incision and adjacent spaces), performed at the end of surgery before emergence from anesthesia. All patients receive standard postoperative analgesia with intravenous patient-controlled opioid analgesia. | Procedure or surgery | Liposomal Bupivacaine Group |
| Bupivacaine Hydrochloride intercostal nerve blockUltrasound-guided intercostal nerve block with 0.25% bupivacaine hydrochloride (20 mL total; 4 mL per intercostal space at the incision and adjacent spaces), performed at the end of surgery before emergence from anesthesia. All patients receive standard postoperative analgesia with intravenous patient-controlled opioid analgesia. | Procedure or surgery | Bupivacaine Hydrochloride Group |
| Standard Postoperative AnalgesiaNo intercostal nerve block. Patients receive standard postoperative analgesia consisting of an intravenous patient-controlled opioid pump per institutional protocol. | Other | Control Group (Standard Analgesia Only) |
Primary outcome
Pain score area under the curve (AUC) from 25 to 72 hours postoperatively
Time frame: 25 to 72 hours after the end of surgery
Area under the curve of postoperative pain intensity measured on the VRS. AUC is computed over the 25-72 h interval. Postoperative pain intensity assessed using the Verbal Response Scale (VRS), the score ranges from 0 to 10, with a total of 11 numbers corresponding to different pain levels: 0 indicates no pain; 1-3 indicates mild pain (tolerable and does not affect sleep); 4-6 indicates moderate pain (significant, affects sleep, and requires medication for relief); and 7-10 indicates severe pain (intense, intolerable, and severely affects life).
2 secondary outcomes
Pain score at PACU discharge and postoperative intervals
Time frame: At PACU discharge, and 6, 12, 24, 48, and 72 hours postoperatively
Cumulative opioid consumption
Time frame: From the end of surgery to 48 hours after surgery
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 30 Mar 2026.
- Derived from this study: PubMed 41560407Huang J, Wang L, Wei S, Xin Y, Chang R, Liu H, Yang Y, Song J, Lv X. Comparison of liposomal bupivacaine and bupivacaine hydrochloride intercostal nerve blocks for postoperative analgesia after thoracic surgery: a multicenter, randomized, three arms trial protocol. Ann Med. 2026 Dec;58(1):2612384. doi: 10.1080/07853890.2025.2612384. Epub 2026 Jan 20.
- Derived from this study: PubMed 41477178Yu J, Wei S, Ling D, Xin Y, Liu H, Yang Y, Li X, Xiang Z, Liu J. Effective Dose of Oliceridine for Inhibiting Hemodynamic Elevation Induced by Tracheal Intubation: An Up-and-Down Sequential Trial. Drug Des Devel Ther. 2025 Dec 26;19:11767-11778. doi: 10.2147/DDDT.S567868. eCollection 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.
Xin Y Lv, PhD study director
Shanghai Pulmonary Hospital, Tongji University, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liposomal Bupivacaine intercostal nerve block, Bupivacaine Hydrochloride intercostal nerve block and Standard Postoperative Analgesia in people with Postoperative Pain, Acute and Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China 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 3 inclusion and 6 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 30 Mar 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Shiyou Wei, PhD (8615601680288, lovewishyou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score area under the curve (AUC) from 25 to 72 hours postoperatively (time frame: 25 to 72 hours after the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07134660, which also lists 2 linked publications.
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 30 Mar 2026.