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

NCT05494502 | Recruiting DMC

• 1 other identifier: 2022-191
• Study Type: interventional
• Target: 1,206
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Breast Neoplasms; Mastectomy; Nerve Block; Dexmedetomidine; Pain, Postoperative; Chronic Pain; Prognosis

Keywords

Breast cancer; Mastectomy; Erector spinae plane block; Dexmedetomidine; Postoperative pain; Chronic postsurgical pain; Long-term prognosis

Outcome Measures

Primary Outcomes (2)

• 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).

  At 6 months after surgery

• 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.

  Up to 3 years after surgery

Secondary Outcomes (5)

• Incidence of chronic postsurgical pain (CPSP) at 3 and 12 months after surgery

  At 3 and 12 months after surgery

• Incidence of neuropathic pain at 3, 6, and 12 months after surgery

  At 3, 6 and 12 months after surgery

• Overall survival (long-term outcome)

  Up to 3 years after surgery

• Event-free survival (long-term outcome)

  Up to 3 years after surgery

• Quality of life (long-term outcome)

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

Other Outcomes (7)

• Pain intensity within the first 3 postoperative days

  At 1 hour, 6 hours, 1 day, 2 days, and 3 days after surgery.

• Subjective sleep quality within the first 3 postoperative days

  At 1 hour, 6 hours, 1 day, 2 days, and 3 days after surgery.

• Patient-reported quality of recovery

  At day 1 after surgery

Study Arms (2)

Erector spinae plane block group

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

General anesthesia alone.

Procedure: Control group

Interventions

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).

Erector spinae plane block group

Control group PROCEDURE

General anesthesia alone.

Control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Peking University Cancer Hospital & Institute: collaborator

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (16)

• 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.

  PMID: 30586070 BACKGROUND

• 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.

  PMID: 32611524 BACKGROUND

• 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.

  PMID: 31114301 BACKGROUND

• 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.

  PMID: 33634743 BACKGROUND

• 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.

  PMID: 33262642 BACKGROUND

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

  PMID: 21772141 BACKGROUND

• 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.

  PMID: 33403545 BACKGROUND

• 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.

  PMID: 33032124 BACKGROUND

• 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.

  PMID: 33610172 BACKGROUND

• 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.

  PMID: 26991622 BACKGROUND

• 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.

  PMID: 33426668 BACKGROUND

• 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.

  PMID: 28100520 BACKGROUND

• 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.

  PMID: 28953508 BACKGROUND

• 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.

  PMID: 34956903 BACKGROUND

• 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.

  PMID: 33426658 BACKGROUND

• Zhang J, Chang CL, Lu CY, Chen HM, Wu SY. Paravertebral block in regional anesthesia with propofol sedation reduces locoregional recurrence in patients with breast cancer receiving breast conservative surgery compared with volatile inhalational without propofol in general anesthesia. Biomed Pharmacother. 2021 Oct;142:111991. doi: 10.1016/j.biopha.2021.111991. Epub 2021 Aug 27.

  PMID: 34449311 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative; Chronic Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Dong-Xin Wang, M.D., Ph.D.

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiongfang Wu, M.D.

CONTACT

+8618310161109; wuqf91@163.com

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

CONTACT

+86 13910731903; wangdongxin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: May 23, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)