AzTrials
AzTrials

Breast NeoplasmsNCT05494502

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

A study testing Erector spinae plane block in people with Breast Neoplasms and Mastectomy, run by Peking University First Hospital at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Breast Neoplasms, Mastectomy, Nerve Block
What is being tested?
Erector spinae plane block
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,206 participants
Where
2 sitesChina
Study dates
23 May 2023to Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Qiongfang Wu, M.D. contact

+8618310161109

wuqf91@163.com

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

+86 13910731903

wangdongxin@hotmail.com

China2 sites, 2 recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Zeng-Mao Lin, M.D., +86 13810098351, Linzengmao@163.com

    Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Ling Yu, M.D., +86 13146203116, fishyu071@sina.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Erector spinae plane block, Control group
Keywords
Breast cancer, Mastectomy, Erector spinae plane block, Dexmedetomidine, Postoperative pain, Chronic postsurgical pain, Long-term prognosis
Medical subject headings
Breast Neoplasms, Pain, Postoperative, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erector spinae plane blockProcedure or surgery

    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 groupProcedure or surgery

    General anesthesia alone.

Study groups in NCT05494502
Study groupRoleWhat they receive
Erector spinae plane block groupExperimentalPrior 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).
Receives: Procedure: Erector spinae plane block
Control groupSham comparatorGeneral anesthesia alone.
Receives: Procedure: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of chronic postsurgical pain (CPSP) 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).

    Measured: At 6 months after surgery

  2. Progression-free survival (long-term outcomes)

    Progression-free survival is defined as the time from randomization to disease progression (recurrence or metastasis) or death from any cause.

    Measured: Up to 3 years after surgery

Secondary outcomes (5)

  1. Incidence of chronic postsurgical pain (CPSP) 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).

    Measured: At 3 and 12 months after surgery

  2. Incidence of neuropathic pain 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.

    Measured: At 3, 6 and 12 months after surgery

  3. Overall survival (long-term outcome)

    Overall survival is defined as the time from randomization to death from any cause.

    Measured: Up to 3 years after surgery

  4. Event-free survival (long-term outcome)

    Event-free survival is defined as the time from randomization to tumor recurrence/metastasis, re-hospitalization for any reason, or death from any cause.

    Measured: Up to 3 years after surgery

  5. Quality of life (long-term outcome)

    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].

    Measured: At 1 year, 2 years, and 3 years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2022
  2. Study start23 May 2023
  3. Primary completionNov 2025 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
1,206 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05494502
Sponsor's protocol ID
2022-191
Status last verified
Jul 2025
First submitted
8 Aug 2022
Last updated
31 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schug SA, Lavand'homme P, Barke A, Korwisi B, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic postsurgical or posttraumatic pain. Pain. 2019 Jan;160(1):45-52. doi: 10.1097/j.pain.0000000000001413.

    PubMed 30586070

  • Wang L, Cohen JC, Devasenapathy N, Hong BY, Kheyson S, Lu D, Oparin Y, Kennedy SA, Romerosa B, Arora N, Kwon HY, Jackson K, Prasad M, Jayasekera D, Li A, Guarna G, Natalwalla S, Couban RJ, Reid S, Khan JS, McGillion M, Busse JW. Prevalence and intensity of persistent post-surgical pain following breast cancer surgery: a systematic review and meta-analysis of observational studies. Br J Anaesth. 2020 Sep;125(3):346-357. doi: 10.1016/j.bja.2020.04.088. Epub 2020 Jun 28.

    PubMed 32611524

  • Saporito A, Aguirre J, Borgeat A, Perren A, Anselmi L, Poggi R, Minotti B, Cafarotti S, La Regina D, Ceruti S. Persistent postdischarge pain and chronic postoperative pain after breast cancer surgery under general anesthesia and single-shot paravertebral block: incidence, characteristics and impact on quality of life and healthcare costs. J Pain Res. 2019 Apr 16;12:1193-1199. doi: 10.2147/JPR.S195702. eCollection 2019.

    PubMed 31114301

  • Kojic K, Clarke H. Important considerations with respect to reducing the transition from acute to persistent postoperative pain. Expert Opin Pharmacother. 2021 May;22(7):779-782. doi: 10.1080/14656566.2021.1892073. Epub 2021 Feb 26. No abstract available.

    PubMed 33634743

  • Rabbitts JA, Palermo TM, Lang EA. A Conceptual Model of Biopsychosocial Mechanisms of Transition from Acute to Chronic Postsurgical Pain in Children and Adolescents. J Pain Res. 2020 Nov 24;13:3071-3080. doi: 10.2147/JPR.S239320. eCollection 2020.

    PubMed 33262642

  • Lavand'homme P. The progression from acute to chronic pain. Curr Opin Anaesthesiol. 2011 Oct;24(5):545-50. doi: 10.1097/ACO.0b013e32834a4f74.

    PubMed 21772141

  • Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6.

    PubMed 33403545

  • Saadawi M, Layera S, Aliste J, Bravo D, Leurcharusmee P, Tran Q. Erector spinae plane block: A narrative review with systematic analysis of the evidence pertaining to clinical indications and alternative truncal blocks. J Clin Anesth. 2021 Feb;68:110063. doi: 10.1016/j.jclinane.2020.110063. Epub 2020 Oct 5.

    PubMed 33032124

  • Zhang Y, Liu T, Zhou Y, Yu Y, Chen G. Analgesic efficacy and safety of erector spinae plane block in breast cancer surgery: a systematic review and meta-analysis. BMC Anesthesiol. 2021 Feb 20;21(1):59. doi: 10.1186/s12871-021-01277-x.

    PubMed 33610172

  • Li Y, Wang B, Zhang LL, He SF, Hu XW, Wong GT, Zhang Y. Dexmedetomidine Combined with General Anesthesia Provides Similar Intraoperative Stress Response Reduction When Compared with a Combined General and Epidural Anesthetic Technique. Anesth Analg. 2016 Apr;122(4):1202-10. doi: 10.1213/ANE.0000000000001165.

    PubMed 26991622

  • Desai N, Kirkham KR, Albrecht E. Local anaesthetic adjuncts for peripheral regional anaesthesia: a narrative review. Anaesthesia. 2021 Jan;76 Suppl 1:100-109. doi: 10.1111/anae.15245.

    PubMed 33426668

  • Vorobeichik L, Brull R, Abdallah FW. Evidence basis for using perineural dexmedetomidine to enhance the quality of brachial plexus nerve blocks: a systematic review and meta-analysis of randomized controlled trials. Br J Anaesth. 2017 Feb;118(2):167-181. doi: 10.1093/bja/aew411.

    PubMed 28100520

  • Perez-Gonzalez O, Cuellar-Guzman LF, Soliz J, Cata JP. Impact of Regional Anesthesia on Recurrence, Metastasis, and Immune Response in Breast Cancer Surgery: A Systematic Review of the Literature. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):751-756. doi: 10.1097/AAP.0000000000000662.

    PubMed 28953508

  • Ramirez MF, Cata JP. Anesthesia Techniques and Long-Term Oncological Outcomes. Front Oncol. 2021 Dec 8;11:788918. doi: 10.3389/fonc.2021.788918. eCollection 2021.

    PubMed 34956903

  • Dockrell L, Buggy DJ. The role of regional anaesthesia in the emerging subspecialty of onco-anaesthesia: a state-of-the-art review. Anaesthesia. 2021 Jan;76 Suppl 1:148-159. doi: 10.1111/anae.15243.

    PubMed 33426658

Questions about this trial

What is this clinical trial studying?

A study testing Erector spinae plane block in people with Breast Neoplasms and Mastectomy, run by Peking University First Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Qiongfang Wu, M.D. (+8618310161109, wuqf91@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of chronic postsurgical pain (CPSP) at 6 months after surgery (time frame: At 6 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05494502, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in