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NCT Number: NCT05494502

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previous breast cancer surgery with an incision of >2 cm;
  • Chronic opioid dependence or long-term intake of analgesic medicines (>3 months);
  • 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;
  • Inability to communicate in the preoperative period because of profound dementia, deafness, language barriers, or end-stage disease;
  • History of malignant tumor in other organs, or a current combination of malignant tumor of other organs;
  • 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;
  • Allergy to ropivacaine.

Treatment and study plan

Erector Spinae Plane Block

Procedure

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).

Control Group

Procedure

General anesthesia alone.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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].

Other outcomes

  1. 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.

  2. 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.

  3. 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).

  4. Length of stay in hospital after surgery

    Time frame: Up to 30 days after surgery

    Length of stay in hospital after surgery

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dong-Xin Wang, M.D., Ph.D.

CONTACT

[email protected]

+86 13910731903

Qiongfang Wu, M.D.

CONTACT

[email protected]

+8618310161109

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • Peking University Cancer Hospital & Institute

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Aug 10, 2022
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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