Liposomal Bupivacaine vs Ropivacaine for TAPBs | NCT06430112

Studies
Liposomal Bupivacaine vs Ropivacaine for TAPBs

NCT06430112

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

May 28, 2024Actual

Enrollment

74Estimated

Phase

Phase 3

Conditions

Abdominal Tumor
Postoperative Analgesia
Liposomal Bupivacaine
Ropivacaine

Interventions

Liposomal Bupivacaine
Ropivacaine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2023Actual

Primary Completion Date

May 20, 2024Actual

Completion Date

Jun 2024Estimated

First Submitted Date

May 21, 2024

First Submission Date that Met QC Criteria

May 21, 2024

First Posted Date

May 28, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2024

Last Update Posted Date

May 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liposomal Bupivacaine group	Experimental	Liposomal Bupivacaine was used in the group	Drug: Liposomal Bupivacaine
Ropivacaine group	Active Comparator	Ropivacaine was used in this group	Drug: Ropivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Liposomal Bupivacaine	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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative opioid use	The amount of drug used in the postoperative analgesia pump	3 days postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Postoperative pain score	Postoperative VAS score	3 days postoperatively
Postoperative adverse reactions	Postoperative adverse reactions were followed up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

(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
(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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ping Yu	Contact	00-86-13631373286		yuping@sysucc.org.cn
Jingdun Xie	Contact	00-86-13560380116		xiejd@sysucc.org.cn

Overall Officials

Name	Affiliation	Role
Jingdun Xie	Department of Anesthesiology,Sun Yat-Sen University Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jingdun Xie	Recruiting	Guangzhou	Guangdong	510060	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

https://www.medicalresearch.org.cn/,Time: After completing the academic paper for publication

Types

Study Protocol

Time Frame

After completing the academic paper for publication

Access Criteria

The persons who were willing to study.

URL

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds