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

Nerve Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06133725
• Other study ID #: TJ-IRB20230951
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: Tongji Hospital
• Contact: Yi Zhang, Dr.
• Phone: 13986039131
• Email: doc_zhang18[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Laparoscopic Hepatectomy
• Nerve Block

Intervention

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.

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology	WuHan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhangyi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The dose of morphine used	dosage of analgesic pump	24 hours after surgery
Secondary	The dose of morphine used	dosage of analgesic pump	1hour, 2hours, 4hours and 8hours after surgery
Secondary	The number of rescue analgesia	times of rescue analgesia	1hour, 2hours, 4hours, 8hours and 24hours after surgery
Secondary	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
Secondary	The value of central venous pressure	ultrasound-guided internal jugular vein catheterization connected with transducer	5min, 10min, 15min and 30min after nerve block
Secondary	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
Secondary	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
Secondary	Postoperative Complications	Including nausea, vomiting, pruritus, dizziness, headache, constipation, urinary retention, respiratory depression and so on.	2hours, 4hours, 8hours and 24hours after surgery
Secondary	Recovery time nodes	drainage tube removal time, offbed activity, or postoperative hospital stay, etc.	follow up patients for an average of half a month