TAPB Combined With RSB Versus ESPB for Postoperative Analgesia After Laparoscopic Liver Resection

NCT ID: NCT06133725

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2024-12-01

Brief Summary

Postoperative pain after laparoscopic hepatectomy is composed of multiple factors, and the peak pain of postoperative pain mainly occurs within the first 24 hours, so it is particularly important to find an appropriate analgesic method. Transversus abdominis plane block (TAPB) and Rectus sheath blocks (RSB) are widely used in abdominal surgery, but too deep a needle tip during RSB may puncture abdominal organs. TAPB and RSB can only provide somatic analgesia, but lack visceral analgesia. Recently, Erector spinae plane block (ESPB) has been used in some studies for analgesia after abdominal surgery. The purpose of this study is to compare the analgesic effect and postoperative recovery effect of erector spinae plane block and transverse abdominis plane block combined with rectus sheath block in patients undergoing laparoscopic hepatectomy. Therefore, this study has important clinical implications.

Detailed Description

In a double-blind randomized controlled study, researchers randomized 60 patients undergoing laparoscopic hepatectomy to TAPB combined with RSB or ESPB, with both groups receiving additional standardized treatment, including multimodal analgesia. The main outcome was the consumption of morphine within 24 hours after surgery. Secondary outcomes included the number of rescue analgesia at 1h, 2h, 4h, 8h and 24 hours after surgery, VAS scores in resting and coughing at 1h, 2h, 4h, 8h and 24h after surgery, CVP values at 5, 10, 15 and 30min after nerve block, QoR-15 patient questionnaire scores before and 24h after surgery, and postoperative liver function (the percentage increase of AST and ALT compare with preoperative), postoperative complications and discharge time.

Conditions

Laparoscopic Hepatectomy; Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

ESPB

erector spinae plane block

Group Type: EXPERIMENTAL

erector spinae plane block

Intervention Type: PROCEDURE

The experimental group received ultrasound-guided erector spinae plane block, and bilateral erector spinae plane block was performed at T7 segment with 20ml 0.375% ropivacaine on each side.While the control group received ultrasound-guided transversus abdominis plane block combined with rectus sheath block, which will be performed under the costal margin with 10ml 0.375% ropivacaine for bilateral transversus abdominis plane block and 10ml 0.375% ropivacaine for bilateral rectus sheath block.

TAPB&RSB

transversus abdominis plane block combined with rectus sheath block

Group Type: ACTIVE_COMPARATOR

erector spinae plane block

Intervention Type: PROCEDURE

The experimental group received ultrasound-guided erector spinae plane block, and bilateral erector spinae plane block was performed at T7 segment with 20ml 0.375% ropivacaine on each side.While the control group received ultrasound-guided transversus abdominis plane block combined with rectus sheath block, which will be performed under the costal margin with 10ml 0.375% ropivacaine for bilateral transversus abdominis plane block and 10ml 0.375% ropivacaine for bilateral rectus sheath block.

Interventions

erector spinae plane block

The experimental group received ultrasound-guided erector spinae plane block, and bilateral erector spinae plane block was performed at T7 segment with 20ml 0.375% ropivacaine on each side.While the control group received ultrasound-guided transversus abdominis plane block combined with rectus sheath block, which will be performed under the costal margin with 10ml 0.375% ropivacaine for bilateral transversus abdominis plane block and 10ml 0.375% ropivacaine for bilateral rectus sheath block.

Intervention Type: PROCEDURE

Other Intervention Names

transversus abdominis plane block combined with rectus sheath block

Eligibility Criteria

Inclusion Criteria

1. ASA grades I-II;

2. Age 18~70 years old;

3. BMI 19～28kg/m2;

4. Patients undergoing elective laparoscopic partial liver resection;

Exclusion Criteria

1. The nerve block cannot be performed, such as skin infection at the puncture site;

2. Daily using the opioid analgesics or have a history of opioid abuse;

3. Allergy or a history of drug allergy to any of the drugs used in the study;

4. Patients have cognitive impairment, mental or neurological diseases, motor or sensory deficits;

5. Coagulation disorders;

6. Severe lung, heart, liver, or kidney dysfunction;

7. Participating in other clinical trials within 3 months before being included in this study;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhangyi

OTHER

Sponsor Role: lead

Responsible Party

Zhangyi

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, China

Countries

China

Central Contacts

Yi Zhang, Dr.

Role: CONTACT

doc_zhang18@163.com

13986039131

Mengke Liu

Role: CONTACT

Lmk2268939177@163.com

15516722009

Facility Contacts

Yi Zhang, Dr.

Role: primary

doc_zhang18@163.com

13986039131

References

Liu M, Mo X, Zhan R, Wang H, Zhao Y, Zhang Y. Erector spinae plane block versus transversus abdominis plane block with rectus sheath block for postoperative analgesia in laparoscopic hepatectomy: a randomized clinical trial. BMC Anesthesiol. 2025 Apr 9;25(1):162. doi: 10.1186/s12871-025-03031-z.

Reference Type: DERIVED

PMID: 40205560 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

TJ-IRB20230951

Identifier Type: -

Identifier Source: org_study_id