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

NCT07289178 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 1stKunmingMC2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

serratus plane block; postoperative hyperalgesia; chronic post-surgical pain; Liposomal Bupivacaine; Radical mastectomy surgery

Outcome Measures

Primary Outcomes (1)

• Mechanical pain threshold around the postoperative incision

  Tactile measurement kits (Von Frey filaments) were used to assess patients' mechanical pain detection thresholds around the surgical incision area and the forearm preoperatively (T1), 24 hours postoperatively (T2), and 48 hours postoperatively (T3). The method for measuring mechanical pain thresholds involved measuring the threshold around the incision at two points 2 cm from either end of the incision and one point 2 cm below the middle of the incision, with the average of the three points taken as the final value. For the forearm, measurements were taken at points 3, 6, and 9 cm from the midpoint of the elbow, and the average of these three points was calculated similarly. The tactile measurement kit consists of filaments of varying thicknesses, with the filament weight corresponding to different levels of mechanical stimulus intensity.

  Detected preoperatively (T1), 24 hours postoperatively (T2), and 48 hours postoperatively (T3)

Study Arms (4)

Low-dose remifentanil saline serratus plane block group

PLACEBO COMPARATOR

Anesthesia induction began with continuous infusion of remifentanil until skin suturing was completed at a low dose of 0.1 μg/(kg·min). After anesthesia induction, 20 ml of normal saline was used for the preoperative quadratus lumborum block group.

Procedure: Serratus Plane block (single injection)

Hight-dose remifentanil saline serratus plane block group

PLACEBO COMPARATOR

Anesthesia induction began with continuous infusion of remifentanil until skin suturing was completed at a high dose of remifentanil 0.3 μg/(kg·min). After anesthesia induction, 20 ml of normal saline was used for the preoperative serratus anterior muscle block group.

Procedure: Serratus Plane block (single injection)

Highight-dose remifentanil with 0.375% ropivacaine serratus plane block group

ACTIVE COMPARATOR

Anesthesia induction began with continuous infusion of remifentanil until the completion of skin suturing, with a high-dose remifentanil infusion rate of 0.3 μg/(kg·min). After anesthesia induction, a pre-saw muscle block was performed using 20 ml of 0.375% ropivacaine.

Procedure: Serratus Plane block (single injection)

Highight-dose remifentanil with 0.665% Liposomal Bupivacaine serratus plane block group

EXPERIMENTAL

Anesthesia induction began with a continuous infusion of remifentanil until the end of skin suturing, at a high dose of remifentanil infusion at 0.3 μg/(kg·min). After anesthesia induction, 20 ml of 0.665% liposomal bupivacaine was administered for a serratus plane block

Procedure: Serratus Plane block (single injection)

Interventions

Serratus Plane block (single injection) PROCEDURE

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

Highight-dose remifentanil with 0.375% ropivacaine serratus plane block group; Highight-dose remifentanil with 0.665% Liposomal Bupivacaine serratus plane block group; Hight-dose remifentanil saline serratus plane block group; Low-dose remifentanil saline serratus plane block group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Select patients scheduled for elective radical mastectomy for breast cancer under general anesthesia, ASA grade I-IV, aged 18-80 years.

You may not qualify if:

• Allergy to the anesthetics used, infection at the puncture site, history of chronic pain and current use of opioid analgesics, history of chest surgery or trauma, drug or alcohol dependence, neurological or psychiatric disorders, severe hepatic or renal insufficiency, pregnancy, body mass index (BMI) greater than 30 kg/m².

Sponsors & Collaborators

• First Affiliated Hospital of Kunming Medical University: lead

Study Sites (1)

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650000, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Injections

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Haixia Jiang

CONTACT

+86-18875200060; 18875200060@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of The first affiliated hospital of KUNMING medical university

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

CN (1)