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Liposomal Bupivacaine vs Ropivacaine for TAPBs

Liposomal Bupivacaine vs Ropivacaine for Ultrasound-guided Transversus Abdominis Plane Blocks in Laparoscopic Lower Abdominal Tumor Resection: A Prospective Randomized Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06430112
Enrollment
74
Registered
2024-05-28
Start date
2023-11-01
Completion date
2024-06-30
Last updated
2024-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Tumor, Liposomal Bupivacaine, Postoperative Analgesia, Ropivacaine

Keywords

liposomal bupivacaine, ropivacaine, transversus abdominis plane block, laparoscopic lower abdominal tumor resection, opioid consumption

Brief 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. 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.

Interventions

DRUGLiposomal Bupivacaine

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).

DRUGRopivacaine

Patients in ropivacaine group were given 0.25% ropivacaine 20ml/ point (two points in total).

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. Patients undergoing laparoscopic resection of lower abdominal tumors 2. ASA grade II-III 3. Age: 18-70 years.

Exclusion criteria

1. (1) The patient does not agree to participate in the clinical study 2. (2) The patient has a clear history of opioid tolerance or allergy 3. (3) The patient has a history of local anesthetic allergy 4. (4) Previous history of dementia, mental illness or other central nervous system diseases 5. (5) Have a history of chronic pain or are taking opioids and other analgesics 6. (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 7. (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. (8) Pregnant women 9. (9) Unable to cooperate with follow-up or poor compliance 10. (10) Patients with acute myocardial infarction, cardiac arrest or shock during surgery or hospitalization 11. (11) ASA score above grade III.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative opioid use3 days postoperativelyThe amount of drug used in the postoperative analgesia pump

Secondary

MeasureTime frameDescription
Postoperative pain score3 days postoperativelyPostoperative VAS score
Postoperative adverse reactions3 days postoperativelyPostoperative adverse reactions were followed up

Countries

China

Contacts

Primary ContactPing Yu
yuping@sysucc.org.cn00-86-13631373286
Backup ContactJingdun Xie
xiejd@sysucc.org.cn00-86-13560380116

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026