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Effect of Liposome Bupivacaine Serratus Plane Block on Postoperative Hyperalgesia and Chronic Post-surgical Pain in Patients Undergoing Radical Mastectomy

NCT07289178 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-12-17

No results posted yet for this study

Summary

Radical mastectomy is currently the mainstream surgical treatment for breast cancer. Patients often experience significant postoperative pain, and some may develop chronic pain. General anesthesia is commonly used, with remifentanil being the most frequently used intraoperative analgesic. However, prolonged high-dose use of remifentanil can induce opioid-induced hyperalgesia (OIH). Previous studies have shown that serratus anterior plane block can reduce acute postoperative pain after radical mastectomy, but it remains unclear whether it can reduce postoperative pain sensitization and the incidence of chronic pain. Liposomal bupivacaine is a new long-acting local anesthetic with an effect lasting up to 72 hours. This study aims to investigate the effect of liposomal bupivacaine serratus anterior plane block on postoperative pain sensitization and chronic pain in patients undergoing radical mastectomy, providing a reference for clinical treatment. The study includes 120 participants. A tactile measurement kit is used to measure the mechanical pain threshold around the surgical incision preoperatively and at 24 and 48 hours postoperatively, as well as postoperative persistent pain scores at 7 days, 1 month, 3 months, and 6 months. The data will then be analyzed to draw conclusions.

Conditions

  • Serratus Plane Block
  • Postoperative Hyperalgesia
  • Chronic Post-surgical Pain
  • Liposomal Bupivacaine
  • Radical Mastectomy Surgery

Interventions

PROCEDURE

Serratus Plane block (single injection)

After anesthesia induction, the same experienced anesthesiologist performed an ultrasound-guided serratus anterior plane block on the surgical side. The skin was routinely disinfected and draped. A linear 10-13 MHz ultrasound probe was used to locate the 5th rib along the mid-axillary line to identify the superficial latissimus dorsi and the deep serratus anterior muscles. A 22G (80 mm) nerve block needle was inserted in-plane from anterolateral to posteroinferior. When the needle tip reached the surface of the serratus anterior muscle, with clear visualization of the tip in place, no aspiration of fluid, and no air, a test dose of 2 ml was first administered. After a hypoechoic area was observed on the ultrasound, and no blood or air was aspirated again, 20 ml of 0.375% ropivacaine was slowly injected in the ropivacaine group, 20 ml of 0.665% liposomal bupivacaine in the liposomal bupivacaine group, and 20 ml of saline in the placebo group, with real-time ultrasound visualization of t

Sponsors & Collaborators

  • First Affiliated Hospital of Kunming Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-10-01
Completion
2026-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07289178 on ClinicalTrials.gov