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
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.