NCT06133725

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 15, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

12 months

First QC Date

October 23, 2023

Last Update Submit

November 13, 2023

Conditions

Laparoscopic HepatectomyNerve Block

Outcome Measures

Primary Outcomes (1)

  • The dose of morphine used

    dosage of analgesic pump

    24 hours after surgery

Secondary Outcomes (8)

  • The dose of morphine used

    1hour, 2hours, 4hours and 8hours after surgery

  • The number of rescue analgesia

    1hour, 2hours, 4hours, 8hours and 24hours after surgery

  • Visual analogue scale scores in resting and coughing state

    1hour, 2hours, 4hours, 8hours and 24hours after surgery

  • The value of central venous pressure

    5min, 10min, 15min and 30min after nerve block

  • QoR-15 scores

    before and 24h after surgery

  • +3 more secondary outcomes

Study Arms (2)

ESPB

EXPERIMENTAL

erector spinae plane block

Procedure: erector spinae plane block

TAPB&RSB

ACTIVE COMPARATOR

transversus abdominis plane block combined with rectus sheath block

Procedure: erector spinae plane block

Interventions

erector spinae plane blockPROCEDURE

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.

Also known as: transversus abdominis plane block combined with rectus sheath block
ESPBTAPB&RSB

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA grades I-II;
  • Age 18\~70 years old;
  • BMI 19～28kg/m2;
  • Patients undergoing elective laparoscopic partial liver resection;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

  • 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.

    PMID: 40205560DERIVED

Central Study Contacts

Yi Zhang, Dr.

CONTACT

13986039131doc_zhang18@163.com

Mengke Liu

CONTACT

15516722009Lmk2268939177@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 23, 2023

First Posted

November 15, 2023

Study Start

November 15, 2023

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

November 15, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)