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

Not Applicable

Not yet recruiting

• Conditions: Nerve Block; Laparoscopic Hepatectomy
• Interventions: Procedure: erector spinae plane block

• Registration Number: NCT06133725
• Lead Sponsor: Zhangyi

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.

Study Timeline

• Study First Submitted: 2023-10-23
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-13
• Last Update Submitted: 2023-11-13
• Study Start: 2023-11-15
• Study First Posted: 2023-11-15
• Last Update Posted: 2023-11-15
• Primary Completion: 2024-11-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESPB	erector spinae plane block	erector spinae plane block
TAPB&RSB	erector spinae plane block	transversus abdominis plane block combined with rectus sheath block

Primary Outcome Measures

Name	Time	Method
The dose of morphine used	24 hours after surgery	dosage of analgesic pump

Secondary Outcome Measures

Name	Time	Method
The number of rescue analgesia	1hour, 2hours, 4hours, 8hours and 24hours after surgery	times of rescue analgesia
Quantitative assessment of liver function	before and 1days, 3days after surgery	The levels of plasma liver function markers AST and ALT before and after liver resection.
Recovery time nodes	follow up patients for an average of half a month	drainage tube removal time, offbed activity, or postoperative hospital stay, etc.
QoR-15 scores	before and 24h after surgery	The QOR-15 scale was scored from 0 (very poor QoR) to 150 (excellent QoR). A higher score indicates a better patient status.
The value of central venous pressure	5min, 10min, 15min and 30min after nerve block	ultrasound-guided internal jugular vein catheterization connected with transducer
Postoperative Complications	2hours, 4hours, 8hours and 24hours after surgery	Including nausea, vomiting, pruritus, dizziness, headache, constipation, urinary retention, respiratory depression and so on.
The dose of morphine used	1hour, 2hours, 4hours and 8hours after surgery	dosage of analgesic pump
Visual analogue scale scores in resting and coughing state	1hour, 2hours, 4hours, 8hours and 24hours after surgery	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.

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology; 🇨🇳 WuHan, Hubei, China