Postoperative PainNCT07577934
Efficacy of Liposomal Bupivacaine for Transversus Abdominis Plane Block
A study testing Liposomal Bupivacaine TAP block and Ropivacaine TAP blocks in people with Postoperative Pain and Liposomal Bupivacaine, run by Tianjin First Central Hospital at 1 site in China.
Trial summary
This is a single-center, randomized, single-blind, parallel-group clinical trial. The study aims to compare the analgesic efficacy of liposomal bupivacaine versus ropivacaine for transversus abdominis plane (TAP) block in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Liposomal Bupivacaine
- What is being tested?
- Liposomal Bupivacaine TAP block and Ropivacaine TAP blocks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2026to 1 Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years, either gender.
- Patients scheduled for elective laparoscopic cholecystectomy.
- ASA physical status I-III.
- Able to provide written informed consent and complete the 3-month follow-up.
Who cannot join
- History of allergy to local anesthetics.
- History of dementia, psychosis, or other central nervous system diseases.
- History of chronic pain or long-term use of opioids or other analgesics.
- Contraindications to nerve block: infection at puncture site, severe coagulopathy.
- Severe hepatic or renal dysfunction, pregnancy, or lactation.
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
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300384
Lili Jia, +86 13102058301, jialili19880801@163.com
About this study
Official title: Liposomal Bupivacaine Versus Ropivacaine for Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy: A Randomized, Single-Blind, Parallel-Group Trial
This is a single-center, randomized, single-blind, parallel-group clinical trial. The study aims to compare the analgesic efficacy of liposomal bupivacaine versus ropivacaine for transversus abdominis plane (TAP) block in patients undergoing laparoscopic cholecystectomy. Eligible participants will be randomly assigned to receive either liposomal bupivacaine or ropivacaine for TAP block during surgery. The primary outcome is the dynamic NRS pain score at 24 hours after surgery. Secondary outcomes include static and dynamic NRS pain scores at multiple time points, QoR-15 recovery quality, time to first rescue analgesia, analgesic consumption, gastrointestinal function recovery, length of hospital stay, and adverse events. Participants will be followed up to 3 months after surgery to evaluate the incidence of chronic post-surgical pain (CPSP). All participants will receive routine clinical care, and participation is voluntary.
- Conditions
- Postoperative Pain, Liposomal Bupivacaine
- Being tested
- Liposomal Bupivacaine TAP block, Ropivacaine TAP blocks
- Keywords
- Liposomal Bupivacaine, Postoperative Pain, Transverse Abdominal Plane Block, Anesthetic Recovery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Bupivacaine TAP blockDrug
Liposomal bupivacaine administered via ultrasound-guided transversus abdominis plane (TAP) block after laparoscopic cholecystectomy.
Ropivacaine TAP blocksDrug
Standard-dose ropivacaine administered via ultrasound-guided transversus abdominis plane (TAP) block after laparoscopic cholecystectomy.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine Group | Experimental | Patients in this group will receive transversus abdominis plane (TAP) block with liposomal bupivacaine after surgery. Receives: Drug: Liposomal Bupivacaine TAP block |
| Ropivacaine group | Active comparator | Patients in this group will receive transversus abdominis plane (TAP) block with Ropivacaine after surgery. Receives: Drug: Ropivacaine TAP blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative dynamic NRS pain score at 24 hours
Postoperative pain intensity under dynamic conditions (e.g., coughing or deep breathing) will be assessed using the Numerical Rating Scale (NRS, 0-10, where 0 = no pain and 10 = worst imaginable pain).
Measured: 24 hours after surgery
Secondary outcomes (7)
Postoperative NRS pain scores at different time points
NRS scores at 24, 48, and 72 hours post-surgery while at rest; NRS scores at 48 and 72 hours while active
Measured: 24, 48, and 72 hours after surgery
Postoperative recovery quality (QoR-15 scale)
Postoperative recovery quality will be evaluated using the 15-item Quality of Recovery (QoR-15) scale at 24 hours after surgery. The total score ranges from 0 to 150, with higher scores indicating better recovery quality.
Measured: 24, 48, and 72 hours after surgery
Time to first rescue analgesia
The time from the end of surgery to the first request for rescue analgesia (e.g., opioid or non-opioid analgesics) will be recorded（background pain is excluded）.
Measured: Up to 72 hours after surgery
Total postoperative analgesic consumption within 72 hours
Total amount of rescue analgesics (e.g., opioids, NSAIDs) used by each patient within 72 hours after surgery will be calculated and converted into equivalent doses.
Measured: 72 hours after surgery
Gastrointestinal function recovery
Time to first flatus and time to first defecation, measured from the end of surgery.
Measured: Postoperatively, through hospital discharge, up to 7 days after surgery
Postoperative length of hospital stay
The total number of days from surgery to hospital discharge will be recorded.
Measured: Postoperatively, through hospital discharge (up to 7 days)
Incidence of adverse events
Adverse events including nausea, vomiting, dizziness, local anesthetic toxicity, and neurological complications will be recorded and compared between groups during hospitalization and follow-up.
Measured: Postoperatively, through hospital discharge, and at follow-up (up to 7 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start10 May 2026
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin First Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Jia, Tianjin First Central Hospital
- Investigators
- Wenli Yu, Study director, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577934
- Sponsor's protocol ID
- KYAP2025-52
- Status last verified
- May 2026
- First submitted
- 21 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be made available upon reasonable request to the corresponding author, beginning 12 months after the publication of the primary results manuscript.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Bupivacaine Versus Ropivacaine for Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy: A Randomized, Single-Blind, Parallel-Group Trial
- ClinicalTrials.gov ID
- NCT07577934
- Acronym / sponsor ID
- KYAP2025-52
- Conditions
- Postoperative Pain, Liposomal Bupivacaine
- Keywords
- Liposomal Bupivacaine, Postoperative Pain, Transverse Abdominal Plane Block, Anesthetic Recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Tianjin First Central HospitalUniversity, hospital or other
- Study start
- 10 May 2026 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 11 May 2026 (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 is a single-center, randomized, single-blind, parallel-group clinical trial. The study aims to compare the analgesic efficacy of liposomal bupivacaine versus ropivacaine for transversus abdominis plane (TAP) block in patients undergoing laparoscopic cholecystectomy. Eligible participants will be randomly assigned to receive either liposomal bupivacaine or ropivacaine for TAP block during surgery. The primary outcome is the dynamic NRS pain score at 24 hours after surgery. Secondary outcomes include static and dynamic NRS pain scores at multiple time points, QoR-15 recovery quality, time to first rescue analgesia, analgesic consumption, gastrointestinal function recovery, length of hospital stay, and adverse events. Participants will be followed up to 3 months after surgery to evaluate the incidence of chronic post-surgical pain (CPSP). All participants will receive routine clinical care, and participation is voluntary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine Group | Experimental | Drug: Liposomal Bupivacaine TAP blockPatients in this group will receive transversus abdominis plane (TAP) block with liposomal bupivacaine after surgery. |
| Ropivacaine group | Active comparator | Drug: Ropivacaine TAP blocksPatients in this group will receive transversus abdominis plane (TAP) block with Ropivacaine after surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years, either gender.
- Patients scheduled for elective laparoscopic cholecystectomy.
- ASA physical status I-III.
- Able to provide written informed consent and complete the 3-month follow-up.
Key exclusion criteria (5 listed)
- History of allergy to local anesthetics.
- History of dementia, psychosis, or other central nervous system diseases.
- History of chronic pain or long-term use of opioids or other analgesics.
- Contraindications to nerve block: infection at puncture site, severe coagulopathy.
- Severe hepatic or renal dysfunction, pregnancy, or lactation.
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 TAP blockLiposomal bupivacaine administered via ultrasound-guided transversus abdominis plane (TAP) block after laparoscopic cholecystectomy. | Drug | Liposomal Bupivacaine Group |
| Ropivacaine TAP blocksStandard-dose ropivacaine administered via ultrasound-guided transversus abdominis plane (TAP) block after laparoscopic cholecystectomy. | Drug | Ropivacaine group |
Primary outcome
Postoperative dynamic NRS pain score at 24 hours
Time frame: 24 hours after surgery
Postoperative pain intensity under dynamic conditions (e.g., coughing or deep breathing) will be assessed using the Numerical Rating Scale (NRS, 0-10, where 0 = no pain and 10 = worst imaginable pain).
7 secondary outcomes
Postoperative NRS pain scores at different time points
Time frame: 24, 48, and 72 hours after surgery
Postoperative recovery quality (QoR-15 scale)
Time frame: 24, 48, and 72 hours after surgery
Time to first rescue analgesia
Time frame: Up to 72 hours after surgery
Total postoperative analgesic consumption within 72 hours
Time frame: 72 hours after surgery
Gastrointestinal function recovery
Time frame: Postoperatively, through hospital discharge, up to 7 days after surgery
Postoperative length of hospital stay
Time frame: Postoperatively, through hospital discharge (up to 7 days)
Incidence of adverse events
Time frame: Postoperatively, through hospital discharge, and at follow-up (up to 7 days 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 14 May 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be made available upon reasonable request to the corresponding author, beginning 12 months after the publication of the primary results manuscript.
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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.
Wenli Yu study director
Tianjin First Central Hospital
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 TAP block and Ropivacaine TAP blocks in people with Postoperative Pain and Liposomal Bupivacaine, run by Tianjin First Central 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 4 inclusion and 5 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 14 May 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. 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 Ke yu Zhang (+86 19861121816, m456365zky@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative dynamic NRS pain score at 24 hours (time frame: 24 hours after surgery). 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 14 May 2026.