Impact of Erector Spinae Plane Block on Chronic Postsurgical Pain in Breast Cancer Patients

July 29, 2025 updated by: Dong-Xin Wang, Peking University First Hospital

Impact of Erector Spinae Plane Block With Adjuvant Dexmedetomidine on Chronic Postsurgical Pain in Breast Cancer Patients: a Two-center Randomized Controlled Trial

Chronic postsurgical pain (CPSP) has an incidence of 46% in patients after breast cancer surgery, which seriously affects patients' physiological and psychological function, as well as quality of life. Acute pain is an independent risk factor for persistent pain after surgery. Erector spinae plane block (ESPB) provided excellent perioperative analgesia in patients undergoing breast surgery. Dexmedetomidine as an adjuvant of local anesthetics prolongs the duration of peripheral nerve block and decreases the requirements of postoperative analgesia. The investigators hypothesize that, for breast cancer patients undergoing mastectomy, ESPB (with a combination of 0.5% ropivacaine 35 ml and dexmedetomidine 1 microgram/kg) can reduce the occurrence of CPSP. The purpose of this randomized controlled trial is to investigate the impact of ESPB with adjuvant dexmedetomidine on the incidence of CPSP in breast cancer patients after mastectomy. We will also observe the impact of ESPB on long-term survival in these patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic postsurgical pain (CPSP), defined as pain persisting or recurring for longer than three months after surgery, has an incidence of 46% in patients after breast cancer surgery. It seriously affects patients' physiological and psychological function, as well as quality of life. Acute pain is an independent risk factor for persistent pain after surgery.

As a core technique in multimodal analgesia, peripheral nerve block plays an important role in controlling acute postoperative pain in breast cancer patients; it may also prevent the occurrence of CPSP. In our previous trial, use of paravertebral block reduced CPSP at six months after breast cancer surgery; the effect was more prominent in the subgroup of patients following mastectomy. But conclusions can not be achieved until now. Regional anesthesia is also supposed to produce favorable effects on long-term oncological outcomes, possibly by relieving surgery-related stress response and immunosuppression. But, again, available evidences are conflicting regarding regional block and long-term cancer outcomes.

The erector spinae plane block (ESPB) was first described by Forero in 2016 and provides excellent perioperative analgesia with minimal side effect in patients undergoing thoracic, breast, and spinal surgeries. As one of the interfacial plane block techniques, the ESPB targets dorsal and ventral rami of the spinal nerves from T2-T7; it may produce effect by diffusing into the paravertebral and intercostal spaces and spreading in both cephalic and caudal directions.

Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative, analgesic and anti-anxiety properties. When used as an adjuvant to local anesthetics, dexmedetomidine prolongs the duration nerve block and decreased the requirement of postoperative analgesia.

The investigators hypothesize that, for breast cancer patients undergoing mastectomy, ESPB (with 0.5% ropivacaine 35 ml combined with dexmedetomidine 1 microgram/kg) can reduce the occurrence of CPSP. The purpose of this randomized controlled trial is to investigate the impact of ESPB with adjuvant dexmedetomidine on the incidence of CPSP in breast cancer patients after mastectomy. We will also observe the effect of ESPB on long-term prognosis in this patient population.

Study Type

Interventional

Enrollment (Estimated)

1206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Qiongfang Wu, M.D.
  • Phone Number: +8618310161109
  • Email: wuqf91@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age of 18 years or over, but less than 85 years;
  2. Scheduled to undergo mastectomy for primary unilateral breast cancer.

Exclusion Criteria:

  1. Previous breast cancer surgery with an incision of >2 cm;
  2. Chronic opioid dependence or long-term intake of analgesic medicines (>3 months);
  3. Any contraindication to erector spinae plane block, including intrathoracic infection, infection at the puncture site, cancer invasion of the puncture site, severe spinal deformity, history of spinal surgery, and severe coagulopathy;
  4. Inability to communicate in the preoperative period because of profound dementia, deafness, language barriers, or end-stage disease;
  5. History of malignant tumor in other organs, or a current combination of malignant tumor of other organs;
  6. History of coronary heart disease (diagnosed coronary stenosis, previous myocardial infarction, previous percutaneous coronary intervention or coronary artery bypass grafting); preoperative hepatic or renal impairment (alanine transaminase and/or aspartate transaminase ≥2 times of upper limit of normal, or serum creatinine>133 µmol/L); history of peptic ulcer or hemorrhage; ASA classification IV or above;
  7. Allergy to ropivacaine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erector spinae plane block group
Prior to general anesthesia, ultrasound guided erector spinae plane block (ESPB; performed with 0.5% ropivacaine 35 ml with dexmedetomidine 1microgram/kg) is performed at T2 level (15 ml) and T4 level (20 ml).
Procedure: Erector spinae plane block
Prior to general anesthesia, ultrasound guided erector spinae plane block (ESPB; performed with 0.5% ropivacaine 35 ml with dexmedetomidine 1 microgram/kg) is performed at T2 level (15 ml) and T4 level (20 ml).
Sham Comparator: Control group
General anesthesia alone.
Procedure: Control group
General anesthesia alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of chronic postsurgical pain (CPSP) at 6 months after surgery
Time Frame: At 6 months after surgery
CPSP is defined as pain persisting for at least three months after surgery that was not present before surgery or that had different characteristics, and other possible causes of pain were excluded (e.g., cancer recurrence, infection).
At 6 months after surgery
Progression-free survival (long-term outcomes)
Time Frame: Up to 3 years after surgery
Progression-free survival is defined as the time from randomization to disease progression (recurrence or metastasis) or death from any cause.
Up to 3 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of chronic postsurgical pain (CPSP) at 3 and 12 months after surgery
Time Frame: At 3 and 12 months after surgery
CPSP is defined as pain persisting for at least three months after surgery that was not present before surgery or that had different characteristics, and other possible causes of pain were excluded (e.g., cancer recurrence, infection).
At 3 and 12 months after surgery
Incidence of neuropathic pain at 3, 6, and 12 months after surgery
Time Frame: At 3, 6 and 12 months after surgery
Neuropathic pain is defined as a score at or above 0 on the Neuropathic Pain Questionnaire Short-form. The questionnaire contains three items, i.e., tingling pain, numbness, and increased pain due to touch. Each item is scored from 0 (no pain) to 100 (worst pain imaginable), and multiplied by a discriminant function coefficient (tingling: 0.017, numbness: 0.015, increased pain to touch: 0.011). The total sum of these is added to a constant value (-1.302) to yield a final score ranging from -1.302 to 2.998, with a cutoff of ≥0 suggesting neuropathic pain.
At 3, 6 and 12 months after surgery
Overall survival (long-term outcome)
Time Frame: Up to 3 years after surgery
Overall survival is defined as the time from randomization to death from any cause.
Up to 3 years after surgery
Event-free survival (long-term outcome)
Time Frame: Up to 3 years after surgery
Event-free survival is defined as the time from randomization to tumor recurrence/metastasis, re-hospitalization for any reason, or death from any cause.
Up to 3 years after surgery
Quality of life (long-term outcome)
Time Frame: At 1 year, 2 years, and 3 years after surgery
Quality of life is assessed with the breast cancer-specific Quality of Life Questionnaire (EORTC QLQ-BR53). It consists of EORTC-C30 [a 30-item questionnaire that provides assessments of functional dimensions (physical, role, cognitive, emotional, social, fatigue, pain, nausea/vomiting, a global health), the total score ranges from 0 to 100, with higher score indicating better function] and EORTC-BR23 [a 23-item questionnaire that provides assessments of symptom dimensions (systemic therapy side effects, arm symptoms, breast symptoms, body image, sexual functioning, sexual enjoyment, feeling of upset due to hair loss, and future perspective), the total score ranges from 0 to 100,with higher score indicating worse symptom].
At 1 year, 2 years, and 3 years after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay in hospital after surgery
Time Frame: Up to 30 days after surgery
Length of stay in hospital after surgery
Up to 30 days after surgery
Incidence of postoperative complications within 30 days
Time Frame: Up to 30 days after surgery
Postoperative complications are generally defined as newly occurred medical conditions that are deemed harmful and required therapeutic intervention within 30 days after surgery.
Up to 30 days after surgery
Pain intensity within the first 3 postoperative days
Time Frame: At 1 hour, 6 hours, 1 day, 2 days, and 3 days after surgery.
Pain intensity is assessed with the numeric rating scale, an 11-point scale where 0=no pain and 10=the worst pain, both at rest and with movement.
At 1 hour, 6 hours, 1 day, 2 days, and 3 days after surgery.
Subjective sleep quality within the first 3 postoperative days
Time Frame: At 1 hour, 6 hours, 1 day, 2 days, and 3 days after surgery.
Subjective sleep quality is assessed with the numeric rating scale, an 11-point scale where 0=the best sleep quality and 10=the worst sleep quality.
At 1 hour, 6 hours, 1 day, 2 days, and 3 days after surgery.
Patient-reported quality of recovery
Time Frame: At day 1 after surgery
Patient-reported quality of recovery is assessed with the Quality of Recovery-15 scale (QoR-15 scale, a 15-item scale to assess the patients' postoperative recovery in physical comfort, emotional state, physical independence, psychological support and pain. For each item, the score ranges from 0 to 10. The total score ranges from 0 to 150, with higher score indicating better recovery).
At day 1 after surgery
Incidence of anxiety at 30 days after surgery
Time Frame: At 30 days after surgery
Anxiety is defined as a score of 8 or above on the anxiety subscale of the Hospital Anxiety and Depression Scale.
At 30 days after surgery
Incidence of depression at 30 days after surgery
Time Frame: At 30 days after surgery
Depression is defined as a score of 8 or above on the depression subscale of the Hospital Anxiety and Depression Scale.
At 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

Peking University Cancer Hospital & Institute

Investigators

  • Principal Investigator: Dong-Xin Wang, M.D., Ph.D., Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2023

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

August 8, 2022

First Submitted That Met QC Criteria

August 8, 2022

First Posted (Actual)

August 10, 2022

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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