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Trial Title:
Liposomal Bupivacaine vs Ropivacaine for TAPBs
NCT ID:
NCT06430112
Condition:
Abdominal Tumor
Postoperative Analgesia
Liposomal Bupivacaine
Ropivacaine
Conditions: Official terms:
Abdominal Neoplasms
Bupivacaine
Ropivacaine
Conditions: Keywords:
liposomal bupivacaine
ropivacaine
transversus abdominis plane block
laparoscopic lower abdominal tumor resection
opioid consumption
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
Liposomal Bupivacaine
Description:
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).
Arm group label:
Liposomal Bupivacaine group
Other name:
Bupivacaine liposome
Intervention type:
Drug
Intervention name:
Ropivacaine
Description:
Patients in ropivacaine group were given 0.25% ropivacaine 20ml/ point (two points in
total).
Arm group label:
Ropivacaine group
Other name:
Ropivacaine Hydrochloride Injection
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jingdun Xie
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Jingdun Xie
Phone:
+8613560380116
Email:
xiejd@sysucc.org.cn
Start date:
November 1, 2023
Completion date:
June 2024
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06430112
