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

Sponsor
Zhangyi (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06133725
Collaborator
(none)
60
1
2
12.6
4.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: erector spinae plane block
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Transversus Abdominis Plane Block Combined With Rectus Sheath Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Laparoscopic Liver Resection
Anticipated Study Start Date :
Nov 15, 2023
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. The dose of morphine used [24 hours after surgery]

      dosage of analgesic pump

    Secondary Outcome Measures

    1. The dose of morphine used [1hour, 2hours, 4hours and 8hours after surgery]

      dosage of analgesic pump

    2. The number of rescue analgesia [1hour, 2hours, 4hours, 8hours and 24hours after surgery]

      times of rescue analgesia

    3. 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.

    4. The value of central venous pressure [5min, 10min, 15min and 30min after nerve block]

      ultrasound-guided internal jugular vein catheterization connected with transducer

    5. 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.

    6. 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.

    7. Postoperative Complications [2hours, 4hours, 8hours and 24hours after surgery]

      Including nausea, vomiting, pruritus, dizziness, headache, constipation, urinary retention, respiratory depression and so on.

    8. Recovery time nodes [follow up patients for an average of half a month]

      drainage tube removal time, offbed activity, or postoperative hospital stay, etc.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology WuHan Hubei China 430030

    Sponsors and Collaborators

    • Zhangyi

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhangyi, Professor, Tongji Hospital
    ClinicalTrials.gov Identifier:
    NCT06133725
    Other Study ID Numbers:
    • TJ-IRB20230951
    First Posted:
    Nov 15, 2023
    Last Update Posted:
    Nov 15, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 15, 2023