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

Sponsor

Peking University First Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05494502

Collaborator

Peking University Cancer Hospital & Institute (Other)

1,206

Enrollment

Locations

Arms

Anticipated Duration (Months)

603

Patients Per Site

10.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms Mastectomy Nerve Block Dexmedetomidine Pain, Postoperative Chronic Pain Prognosis	Procedure: Erector spinae plane block Procedure: Control group	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1206 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jul 1, 2027

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Incidence of chronic postsurgical pain (CPSP) at 6 months after surgery [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).
Progression-free survival (long-term outcomes) [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 Outcome Measures

Incidence of chronic postsurgical pain (CPSP) at 3 and 12 months after surgery [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).
Incidence of neuropathic pain at 3, 6, and 12 months after surgery [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.
Overall survival (long-term outcome) [Up to 3 years after surgery]
Overall survival is defined as the time from randomization to death from any cause.
Event-free survival (long-term outcome) [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.
Quality of life (long-term outcome) [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 Outcome Measures

Pain intensity within the first 3 postoperative days [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.
Subjective sleep quality within the first 3 postoperative days [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.
Patient-reported quality of recovery [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).
Length of stay in hospital after surgery [Up to 30 days after surgery]
Length of stay in hospital after surgery
Incidence of postoperative complications within 30 days [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.
Incidence of anxiety at 30 days after surgery [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.
Incidence of depression at 30 days after surgery [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.