Abdominal TumorPhase 3NCT06430112
Liposomal Bupivacaine vs Ropivacaine for TAPBs
A Phase 3 study testing Liposomal Bupivacaine and Ropivacaine in people with Abdominal Tumor and Postoperative Analgesia, run by Sun Yat-sen University at 1 site in China.
Trial summary
Few studies have compared the efficacy of ultrasound (US)-guided TAP blocks with Liposomal bupivacaine(LB) versus ropivacaine in reducing postoperative opioid usage in patients undergoing laparoscopic lower abdominal tumor Resection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Abdominal Tumor, Postoperative Analgesia, Liposomal Bupivacaine
- What is being tested?
- Liposomal Bupivacaine and Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to Jun 2024
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing laparoscopic resection of lower abdominal tumors
- ASA grade II-III
- Age: 18-70 years.
Who cannot join
- (1) The patient does not agree to participate in the clinical study
- (2) The patient has a clear history of opioid tolerance or allergy
- (3) The patient has a history of local anesthetic allergy
- (4) Previous history of dementia, mental illness or other central nervous system diseases
- (5) Have a history of chronic pain or are taking opioids and other analgesics
- (6) Patients are generally in poor condition with a history of serious diseases of cardiovascular system, respiratory system, digestive system, urinary system or central nervous system, and may not survive for more than 3 months
Show all 11Show fewer
- (7) The patient had any of the following conditions in the 12 months before surgery: myocardial infarction, severe/unstable angina pectoris, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident, pulmonary embolism
- (8) Pregnant women
- (9) Unable to cooperate with follow-up or poor compliance
- (10) Patients with acute myocardial infarction, cardiac arrest or shock during surgery or hospitalization
- (11) ASA score above grade III.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jingdun Xie
Guangzhou, Guangdong, 510060
Jingdun Xie, +8613560380116, xiejd@sysucc.org.cn
About this study
Official title: Liposomal Bupivacaine vs Ropivacaine for Ultrasound-guided Transversus Abdominis Plane Blocks in Laparoscopic Lower Abdominal Tumor Resection: A Prospective Randomized Trial
Few studies have compared the efficacy of ultrasound (US)-guided TAP blocks with Liposomal bupivacaine(LB) versus ropivacaine in reducing postoperative opioid usage in patients undergoing laparoscopic lower abdominal tumor Resection. Therefore, we are conducting this prospective, randomized controlled trial to compare the postoperative analgesic effects of LB and ropivacaine for TAP blocks among patients undergoing laparoscopic colorectal procedures.
Read the detailed description
This study aimed to investigate the impact of liposomal bupivacaine (LB) on postoperative opioid usage for ultrasound(US)-guided transversus abdominis plane (TAP) blocks in laparoscopic colorectal resections. We divided 76 patients into two groups. An injection of bilateral TAP blocks was administered to LB group using 133mg liposomal bupivacaine in each block (266mg total), and to R group using 20 ml 0.25% ropivacaine in each block (40 ml total). Opioid consumption and pain scores at 6h, 24h, 48h and 72h were recorded postoperatively, as well as the total intraoperative remifentanil dose, the hospital stay lengths after surgery, and adverse events including dizziness, nausea, and vomiting.
- Being tested
- Liposomal Bupivacaine, Ropivacaine
- Keywords
- liposomal bupivacaine, ropivacaine, transversus abdominis plane block, laparoscopic lower abdominal tumor resection, opioid consumption
- Medical subject headings
- Abdominal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal BupivacaineDrug
Also called Bupivacaine liposome
After induction of anesthesia, bilateral TAPB was performed under ultrasound guidance. The patients in the bupivacaine liposome group were injected with bupivacaine liposome 133mg(10ml+ 10ml 0.9% normal saline mixed into 20ml)/ point (two points in total).
RopivacaineDrug
Also called Ropivacaine Hydrochloride Injection
Patients in ropivacaine group were given 0.25% ropivacaine 20ml/ point (two points in total).
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine group | Experimental | Liposomal Bupivacaine was used in the group Receives: Drug: Liposomal Bupivacaine |
| Ropivacaine group | Active comparator | Ropivacaine was used in this group Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid use
The amount of drug used in the postoperative analgesia pump
Measured: 3 days postoperatively
Secondary outcomes (2)
Postoperative pain score
Postoperative VAS score
Measured: 3 days postoperatively
Postoperative adverse reactions
Postoperative adverse reactions were followed up
Measured: 3 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start1 Nov 2023
- Primary completion20 May 2024
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal TumorStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Yu, Sun Yat-sen University
- Investigators
- Jingdun Xie, Principal investigator, Department of Anesthesiology,Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430112
- Sponsor's protocol ID
- B2023-485-01
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 28 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://www.medicalresearch.org.cn/,Time: After completing the academic paper for publication
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Bupivacaine vs Ropivacaine for Ultrasound-guided Transversus Abdominis Plane Blocks in Laparoscopic Lower Abdominal Tumor Resection: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT06430112
- Acronym / sponsor ID
- B2023-485-01
- Keywords
- liposomal bupivacaine, ropivacaine, transversus abdominis plane block, laparoscopic lower abdominal tumor resection, opioid consumption
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- Jun 2024 (estimated)
- First posted
- 28 May 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.
Few studies have compared the efficacy of ultrasound (US)-guided TAP blocks with Liposomal bupivacaine(LB) versus ropivacaine in reducing postoperative opioid usage in patients undergoing laparoscopic lower abdominal tumor Resection. Therefore, we are conducting this prospective, randomized controlled trial to compare the postoperative analgesic effects of LB and ropivacaine for TAP blocks among patients undergoing laparoscopic colorectal procedures.
Detailed description
This study aimed to investigate the impact of liposomal bupivacaine (LB) on postoperative opioid usage for ultrasound(US)-guided transversus abdominis plane (TAP) blocks in laparoscopic colorectal resections. We divided 76 patients into two groups. An injection of bilateral TAP blocks was administered to LB group using 133mg liposomal bupivacaine in each block (266mg total), and to R group using 20 ml 0.25% ropivacaine in each block (40 ml total). Opioid consumption and pain scores at 6h, 24h, 48h and 72h were recorded postoperatively, as well as the total intraoperative remifentanil dose, the hospital stay lengths after surgery, and adverse events including dizziness, nausea, and vomiting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine group | Experimental | Drug: Liposomal BupivacaineLiposomal Bupivacaine was used in the group |
| Ropivacaine group | Active comparator | Drug: RopivacaineRopivacaine was used in this group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing laparoscopic resection of lower abdominal tumors
- ASA grade II-III
- Age: 18-70 years.
Key exclusion criteria (11 listed)
- (1) The patient does not agree to participate in the clinical study
- (2) The patient has a clear history of opioid tolerance or allergy
- (3) The patient has a history of local anesthetic allergy
- (4) Previous history of dementia, mental illness or other central nervous system diseases
- (5) Have a history of chronic pain or are taking opioids and other analgesics
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: Bupivacaine liposomeAfter induction of anesthesia, bilateral TAPB was performed under ultrasound guidance. The patients in the bupivacaine liposome group were injected with bupivacaine liposome 133mg(10ml+ 10ml 0.9% normal saline mixed into 20ml)/ point (two points in total). | Drug | Liposomal Bupivacaine group |
| RopivacaineAlso: Ropivacaine Hydrochloride InjectionPatients in ropivacaine group were given 0.25% ropivacaine 20ml/ point (two points in total). | Drug | Ropivacaine group |
Primary outcome
Postoperative opioid use
Time frame: 3 days postoperatively
The amount of drug used in the postoperative analgesia pump
2 secondary outcomes
Postoperative pain score
Time frame: 3 days postoperatively
Postoperative adverse reactions
Time frame: 3 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Individual participant dataSharing planned: Yes. https://www.medicalresearch.org.cn/,Time: After completing the academic paper for publication
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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.
Jingdun Xie principal investigator
Department of Anesthesiology,Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liposomal Bupivacaine and Ropivacaine in people with Abdominal Tumor and Postoperative Analgesia, run by Sun Yat-sen University 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 11 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: status not confirmed, as of the sponsor's last update on 28 May 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping Yu (00-86-13631373286, yuping@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opioid use (time frame: 3 days 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 28 May 2024.