Liposomal Bupivacaine vs Ropivacaine for TAPBs

NCT ID: NCT06430112

Last Updated: 2024-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Abdominal Tumor Postoperative Analgesia Liposomal Bupivacaine Ropivacaine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Liposomal Bupivacaine group

Liposomal Bupivacaine was used in the group

Group Type EXPERIMENTAL

Liposomal Bupivacaine

Intervention Type DRUG

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).

Ropivacaine group

Ropivacaine was used in this group

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

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

Interventions

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Liposomal 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).

Intervention Type DRUG

Ropivacaine

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

Intervention Type DRUG

Other Intervention Names

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Bupivacaine liposome Ropivacaine Hydrochloride Injection

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Ping Yu

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jingdun Xie

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology,Sun Yat-Sen University Cancer Center

Locations

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Jingdun Xie

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ping Yu

Role: CONTACT

00-86-13631373286

Jingdun Xie

Role: CONTACT

00-86-13560380116

Facility Contacts

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Jingdun Xie

Role: primary

+8613560380116

Other Identifiers

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B2023-485-01

Identifier Type: -

Identifier Source: org_study_id

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