Chronic Pain Clinical Trial
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
NCT number | NCT05494502 |
Other study ID # | 2022-191 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 23, 2023 |
Est. completion date | July 2027 |
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.
Status | Recruiting |
Enrollment | 1206 |
Est. completion date | July 2027 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Cancer Hospital | Beijing | Beijing |
China | Peking University First Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University First Hospital | Peking University Cancer Hospital & Institute |
China,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pain intensity within the first 3 postoperative days | 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. | At 1 hour, 6 hours, 1 day, 2 days, and 3 days after surgery. | |
Other | Subjective sleep quality within the first 3 postoperative days | 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. | At 1 hour, 6 hours, 1 day, 2 days, and 3 days after surgery. | |
Other | Patient-reported quality of recovery | 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). | At day 1 after surgery | |
Other | Length of stay in hospital after surgery | Length of stay in hospital after surgery | Up to 30 days after surgery | |
Other | Incidence of postoperative complications within 30 days | Postoperative complications are generally defined as newly occurred medical conditions that are deemed harmful and required therapeutic intervention within 30 days after surgery. | Up to 30 days after surgery | |
Other | Incidence of anxiety 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. | At 30 days after surgery | |
Other | Incidence of depression 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. | At 30 days after surgery | |
Primary | 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 | |
Primary | 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 | 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). | At 3 and 12 months after surgery | |
Secondary | 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. | At 3, 6 and 12 months after surgery | |
Secondary | Overall survival (long-term outcome) | Overall survival is defined as the time from randomization to death from any cause. | Up to 3 years after surgery | |
Secondary | 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. | Up to 3 years after surgery | |
Secondary | 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]. | At 1 year, 2 years, and 3 years after surgery |
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