Ultrasound-guided Multilevel Erectorspinae Plane Block Versus Thoracic Epidural Analgesia for Prevention of Post Mastectomy Pain Syndrome for Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Erector spinae plane block (ESPB), Thoracic epidural block.
- Who it may be relevant to
- Registry conditions: Ultrasound, Multilevel Erector Spinae Plane Block, Thoracic Epidural Analgesia, Post Mastectomy. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The aim of this study is to compare the analgesic efficacy of multilevel erector spinae plane block (ESPB) vs thoracic epidural in modified radical mastectomy (MRM) regarding duration of analgesia, postoperative opioid consumption, effect on intraoperative fentanyl consumption, postoperative numerical pain rating scale and quality of life for the next 6 months.
Detailed description
Breast cancer is the most common malignancy among females. Modified Radical Mastectomy (MRM) is the principal surgical treatment for breast cancer. The standard mode of anesthesia is general anesthesia, in addition to regional blocks for effective postoperative pain control.
Pain is usually managed by narcotics, which have many side effects, including prolonged sedation, increasing incidence of pain recurrence, respiratory depression, nausea \& vomiting and paralytic ileus. All requiring close monitoring and in some occasions Intensive Care Unit (ICU) admission. Thoracic epidural and paravertebral blocks are the gold standard techniques. However, both techniques may lead to some serious complications including spinal cord injury, pneumothorax, incompatibility with pre-existing anticoagulation or antiplatelet therapy and hemodynamic instability.
Recently, multiple regional techniques have been used for postoperative thoracic pain control, including that caused by modified radical mastectomy. Interfascial plane blocks are currently the hot topic in management of postoperative pain. One of these blocks is erector spinae plane block (ESPB). It is an interfacial Para spinal plane block that is simple, safe, effective and associated with fewer complications in comparison to the gold standard techniques.
Interventions
- Drug Erector spinae plane block (ESPB)
Erector spinae plane block (ESPB) using multilevel injections of bupivacaine 0.25%. We will inject 15ml at the level of T2 and 15ml at the level of T5. - Drug Thoracic epidural block
Thoracic epidural block at level of T5 -T6 using 10 ml of bupivacaine 0.25% as a bolus followed by 5 ml bupivacaine 0.25% every 1-2 hours depending on the duration of surgery and the response of the patient.
Primary outcome measures
- The average duration of analgesia [Time frame: 24 hours postoperatively]
Secondary outcome measures (10)
- The total amount of morphine [Time frame: 24 hours postoperatively]
- Incidence of postmastectomy pain syndrome [Time frame: 6 months postoperatively]
- The total amount of fentanyl [Time frame: Intraoperatively]
- Heart rate (HR) [Time frame: 24 hours Postoperatively]
- Mean arterial blood pressure (MAP) [Time frame: 24 hours Postoperatively]
- Degree of pain [Time frame: 24 hours Postoperatively]
- Incidence of Postoperative nausea and vomiting (PONV). [Time frame: 24 hours Postoperatively]
- Complications related to the block [Time frame: 6 months postoperatively]
- Morphine-related complications [Time frame: 24 hours Postoperatively]
- Patient's satisfaction [Time frame: 24 hours Postoperatively]
Eligibility criteria
Inclusion criteria
- Female patients age ≥ 18 years and ≤ 65 Years.
- Type of surgery; Modified Radical Mastectomy (MRM)
- Physical status ASA II, III.
- Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
Exclusion criteria
- Patient refusal.
- Allergy or a contraindication to the drug used in the study, e.g. local anesthetics, opioids.
- History of psychological disorders.
- History of chronic pain.
- Contraindication to regional anesthesia e.g. sepsis, peripheral neuropathies and coagulopathy.
- Advanced chronic renal disease, which is defined as a chronic kidney disease (CKD) in which there is a severe reduction in glomerular filtration rate (GFR < 30 ml/min) and includes stages 4 and 5 of the CKD classification.
- Decompensated cirrhosis, which is defined as an acute deterioration in liver function in a patient with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage.
- Severe heart disease which is defined as NYHA class iii (moderate symptoms with less than normal activity, marked limitation of function status) or NYHA class IV (severe symptoms with features of heart failure with minimal activity or at rest and severe limitation of functional status)
- Severe lung disease which includes oxygen saturation of blood less than 92%, RR more than 20, FEV1/FVC ratio less than 60%.
- Pregnancy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- National Cancer Institute — Cairo
Identifiers
NCT: NCT06884852 · AP2405-201-046-193