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

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

NCT ID: NCT05494502

Condition: Breast Neoplasms
Mastectomy
Nerve Block
Dexmedetomidine
Pain, Postoperative
Chronic Pain
Prognosis

Conditions: Official terms:
Breast Neoplasms
Chronic Pain
Pain, Postoperative
Mastodynia

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

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Double (Investigator, Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: Erector spinae plane block
Description: 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).
Arm group label: Erector spinae plane block group

Intervention type: Procedure
Intervention name: Control group
Description: General anesthesia alone.
Arm group label: Control group

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.

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 85 Years

Healthy volunteers: No

Locations:

Facility:
Name: Peking University First Hospital

Address:
City: Beijing
Zip: 100034
Country: China

Status: Recruiting

Contact:
Last name: Zeng-Mao Lin, M.D.

Phone: +86 13810098351
Email: Linzengmao@163.com

Facility:
Name: Beijing Cancer Hospital

Address:
City: Beijing
Zip: 100142
Country: China

Status: Not yet recruiting

Contact:
Last name: Ling Yu, M.D.

Phone: +86 13146203116
Email: fishyu071@sina.com

Start date: May 23, 2023

Completion date: July 2027

Lead sponsor:
Agency: Peking University First Hospital
Agency class: Other

Collaborator:
Agency: Peking University Cancer Hospital & Institute
Agency class: Other

Source: Peking University First Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05494502