NCT06427044

Brief Summary

This study aims to investigate the effect and influence of liposome bupivacaine anterior serrat plane block on postoperative chronic pain in breast cancer patients, evaluate the therapeutic effect of liposome bupivacaine in postoperative chronic pain, and provide a new method for patients with postoperative chronic pain.

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
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 23, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

May 25, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

May 23, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

May 19, 2024

Last Update Submit

May 19, 2024

Conditions

Breast Cancer Patients With Chronic Pain After Surgery

Outcome Measures

Primary Outcomes (1)

  • Incidence of chronic pain 3 months after surgery

    Pain levels were measured three months after surgery

    Three months after surgery

Study Arms (2)

Anterior serratus block group

EXPERIMENTAL

Bupivacaine lipid 20mL (20mL 266mg bupivacaine liposomes) was ultrasound-guided for a single anterior serranus plane block

Drug: Anterior serratus block group

Control group

NO INTERVENTION

Interventions

Anterior serratus block groupDRUG

Bupivacaine lipid 20mL (20mL 266mg bupivacaine liposomes) was ultrasound-guided for a single anterior serranus plane block

Anterior serratus block group

Eligibility Criteria

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

You may qualify if:

  • Adult patients (aged ≥18 years) who are scheduled to undergo unilateral modified radical breast cancer surgery

You may not qualify if:

  • \. Patients with coagulation dysfunction 2. There are infected patients at the puncture site 3. For patients allergic to any trial drug 4. Patients who take painkillers within 48 hours before surgery 5. Severe cardiopulmonary insufficiency, such as EF\< 40%, FEVC \< 50% expected; Uncontrolled hypertension; 6. Refuse to perform nerve block puncture 7. Mental disorders, epilepsy history; 8. Unable to give informed consent or are participating in other clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Wuhan, Hubei, 430000, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 19, 2024

First Posted

May 23, 2024

Study Start

May 25, 2024

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

May 23, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)