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

Transversus Abdominis Plane Block Combined With Rectus Sheath Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Laparoscopic Liver Resection

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nerve Block; Laparoscopic Hepatectomy
• Intervention / Treatment: Procedure: erector spinae plane block

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Zhang, Dr.; Phone Number: 13986039131; Email: doc_zhang18@163.com
• Study Contact Backup: Name: Mengke Liu; Phone Number: 15516722009; Email: Lmk2268939177@163.com

Study Locations

• China
  • Hubei
    • WuHan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
      • Contact: Yi Zhang, Dr.; Phone Number: 13986039131; Email: doc_zhang18@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESPB; erector spinae plane block	Procedure: 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.; Other Names: transversus abdominis plane block combined with rectus sheath block
Active Comparator: TAPB&RSB; transversus abdominis plane block combined with rectus sheath block	Procedure: 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.; Other Names: transversus abdominis plane block combined with rectus sheath block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The dose of morphine used	dosage of analgesic pump	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The dose of morphine used	dosage of analgesic pump	1hour, 2hours, 4hours and 8hours after surgery
The number of rescue analgesia	times of rescue analgesia	1hour, 2hours, 4hours, 8hours and 24hours after surgery
Visual analogue scale scores in resting and coughing state	Visual analogue scale (VAS): a 100 mm transverse line with 0mm at one end of the line indicates no pain, 100mm at the other end indicates severe pain and the middle part shows different levels of pain.	1hour, 2hours, 4hours, 8hours and 24hours after surgery
The value of central venous pressure	ultrasound-guided internal jugular vein catheterization connected with transducer	5min, 10min, 15min and 30min after nerve block
QoR-15 scores	The QOR-15 scale was scored from 0 (very poor QoR) to 150 (excellent QoR). A higher score indicates a better patient status.	before and 24h after surgery
Quantitative assessment of liver function	The levels of plasma liver function markers AST and ALT before and after liver resection.	before and 1days, 3days after surgery
Postoperative Complications	Including nausea, vomiting, pruritus, dizziness, headache, constipation, urinary retention, respiratory depression and so on.	2hours, 4hours, 8hours and 24hours after surgery
Recovery time nodes	drainage tube removal time, offbed activity, or postoperative hospital stay, etc.	follow up patients for an average of half a month

Collaborators and Investigators

• Sponsor: Zhangyi

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: TJ-IRB20230951

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No