Laparoscopic HepatectomyNCT06133725
TAPB Combined With RSB Versus ESPB for Postoperative Analgesia After Laparoscopic Liver Resection
A study testing erector spinae plane block in people with Laparoscopic Hepatectomy and Nerve Block, run by Zhangyi at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Laparoscopic Hepatectomy, Nerve Block
- What is being tested?
- erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA grades I-II;
- Age 18~70 years old;
- BMI 19～28kg/m2;
- Patients undergoing elective laparoscopic partial liver resection;
Who cannot join
- The nerve block cannot be performed, such as skin infection at the puncture site;
- Daily using the opioid analgesics or have a history of opioid abuse;
- Allergy or a history of drug allergy to any of the drugs used in the study;
- Patients have cognitive impairment, mental or neurological diseases, motor or sensory deficits;
- Coagulation disorders;
- Severe lung, heart, liver, or kidney dysfunction;
- Participating in other clinical trials within 3 months before being included in this study;
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030
Yi Zhang, Dr., 13986039131, doc_zhang18@163.com
About this study
Official title: 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.
Read the 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
- Being tested
- erector spinae plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae plane blockProcedure or surgery
Also called transversus abdominis plane block combined with rectus sheath 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.
| Study group | Role | What they receive |
|---|---|---|
| ESPB | Experimental | erector spinae plane block Receives: Procedure: erector spinae plane block |
| TAPB&RSB | Active comparator | transversus abdominis plane block combined with rectus sheath block Receives: Procedure: erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dose of morphine used
dosage of analgesic pump
Measured: 24 hours after surgery
Secondary outcomes (8)
The dose of morphine used
dosage of analgesic pump
Measured: 1hour, 2hours, 4hours and 8hours after surgery
The number of rescue analgesia
times of rescue analgesia
Measured: 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.
Measured: 1hour, 2hours, 4hours, 8hours and 24hours after surgery
The value of central venous pressure
ultrasound-guided internal jugular vein catheterization connected with transducer
Measured: 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.
Measured: 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.
Measured: before and 1days, 3days after surgery
Postoperative Complications
Including nausea, vomiting, pruritus, dizziness, headache, constipation, urinary retention, respiratory depression and so on.
Measured: 2hours, 4hours, 8hours and 24hours after surgery
Recovery time nodes
drainage tube removal time, offbed activity, or postoperative hospital stay, etc.
Measured: follow up patients for an average of half a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start15 Nov 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic HepatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhangyi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhangyi, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133725
- Sponsor's protocol ID
- TJ-IRB20230951
- Status last verified
- Nov 2023
- First submitted
- 23 Oct 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40205560
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane Block Combined With Rectus Sheath Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Laparoscopic Liver Resection
- ClinicalTrials.gov ID
- NCT06133725
- Acronym / sponsor ID
- TJ-IRB20230951
- Conditions
- Laparoscopic Hepatectomy, Nerve Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ZhangyiUniversity, hospital or other
- Study start
- 15 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB | Experimental | Procedure: erector spinae plane blockerector spinae plane block |
| TAPB&RSB | Active comparator | Procedure: erector spinae plane blocktransversus abdominis plane block combined with rectus sheath block |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA grades I-II;
- Age 18~70 years old;
- BMI 19～28kg/m2;
- Patients undergoing elective laparoscopic partial liver resection;
Key exclusion criteria (7 listed)
- The nerve block cannot be performed, such as skin infection at the puncture site;
- Daily using the opioid analgesics or have a history of opioid abuse;
- Allergy or a history of drug allergy to any of the drugs used in the study;
- Patients have cognitive impairment, mental or neurological diseases, motor or sensory deficits;
- Coagulation disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| erector spinae plane blockAlso: transversus abdominis plane block combined with rectus sheath blockThe 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. | Procedure or surgery | ESPB, TAPB&RSB |
Primary outcome
The dose of morphine used
Time frame: 24 hours after surgery
dosage of analgesic pump
8 secondary outcomes
The dose of morphine used
Time frame: 1hour, 2hours, 4hours and 8hours after surgery
The number of rescue analgesia
Time frame: 1hour, 2hours, 4hours, 8hours and 24hours after surgery
Visual analogue scale scores in resting and coughing state
Time frame: 1hour, 2hours, 4hours, 8hours and 24hours after surgery
The value of central venous pressure
Time frame: 5min, 10min, 15min and 30min after nerve block
QoR-15 scores
Time frame: before and 24h after surgery
Quantitative assessment of liver function
Time frame: before and 1days, 3days after surgery
Postoperative Complications
Time frame: 2hours, 4hours, 8hours and 24hours after surgery
Recovery time nodes
Time frame: follow up patients for an average of half a month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Derived from this study: PubMed 40205560Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing erector spinae plane block in people with Laparoscopic Hepatectomy and Nerve Block, run by Zhangyi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Zhang, Dr. (13986039131, doc_zhang18@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The dose of morphine used (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06133725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.