## Protocol Section
### Identification Module
**NCT ID:** NCT06430112

**Brief Title:** Liposomal Bupivacaine vs Ropivacaine for TAPBs

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

#### Organization Study ID Info
**ID:** B2023-485-01
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2024-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05-20

**Type:** ACTUAL

#### Start Date
**Date:** 2023-11-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Sun Yat-sen University

#### Responsible Party

**Investigator Affiliation:** Sun Yat-sen University

**Investigator Full Name:** Ping Yu

**Investigator Title:** Doctor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### 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.

### Conditions Module

**Conditions:**

- Abdominal Tumor

- Postoperative Analgesia

- Liposomal Bupivacaine

- Ropivacaine

**Keywords:**

- liposomal bupivacaine

- ropivacaine

- transversus abdominis plane block

- laparoscopic lower abdominal tumor resection

- opioid consumption

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 74

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Liposomal Bupivacaine was used in the group

**Intervention Names:**

- Drug: Liposomal Bupivacaine

**Label:** Liposomal Bupivacaine group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Ropivacaine was used in this group

**Intervention Names:**

- Drug: Ropivacaine

**Label:** Ropivacaine group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Liposomal Bupivacaine group

**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).

**Name:** Liposomal Bupivacaine

**Other Names:**

- Bupivacaine liposome

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Ropivacaine group

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

**Name:** Ropivacaine

**Other Names:**

- Ropivacaine Hydrochloride Injection

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The amount of drug used in the postoperative analgesia pump

**Measure:** Postoperative opioid use

**Time Frame:** 3 days postoperatively

#### Secondary Outcomes

**Description:** Postoperative VAS score

**Measure:** Postoperative pain score

**Time Frame:** 3 days postoperatively

**Description:** Postoperative adverse reactions were followed up

**Measure:** Postoperative adverse reactions

**Time Frame:** 3 days postoperatively

### Eligibility Module

**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.

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** yuping@sysucc.org.cn

**Name:** Ping Yu

**Phone:** 00-86-13631373286

**Role:** CONTACT

**Contact 2:**

**Email:** xiejd@sysucc.org.cn

**Name:** Jingdun Xie

**Phone:** 00-86-13560380116

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Guangzhou

**Contacts:**

***Contact 1:***

- **Email:** xiejd@sysucc.org.cn

- **Name:** Jingdun Xie

- **Phone:** +8613560380116

- **Role:** CONTACT

**Country:** China

**Facility:** Jingdun Xie

**State:** Guangdong

**Status:** RECRUITING

**Zip:** 510060

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Anesthesiology,Sun Yat-Sen University Cancer Center

**Name:** Jingdun Xie

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** The persons who were willing to study.

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

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** After completing the academic paper for publication

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7

- Name: Abdominal Neoplasms

- Relevance: HIGH

- As Found: Abdominal Tumors

### Condition Browse Module - Meshes

- ID: D000000008

- Term: Abdominal Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000000779

- Term: Anesthetics, Local

- ID: D000000777

- Term: Anesthetics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Analg

- Name: Analgesics

### Intervention Browse Module - Browse Leaves

- ID: M5315

- Name: Bupivacaine

- Relevance: HIGH

- As Found: Following

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M1700

- Name: Ropivacaine

- Relevance: HIGH

- As Found: Eye

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002045

- Term: Bupivacaine

- ID: D000077212

- Term: Ropivacaine

### Misc Info Module

- Version Holder: 2024-05-31
