Clinical trial NCT06884852: Ultrasound-guided Multilevel Erectorspinae Plane Block Versus Thoracic Epidural Analgesia for Prevention of Post Mastectomy Pain Syndrome for Breast Cancer Patients
Official title: Ultrasound-guided Multilevel Erectorspinae Plane Block Versus Thoracic Epidural Analgesia for Prevention of Post Mastectomy Pain Syndrome for Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ultrasound
Multilevel Erector Spinae Plane Block
Thoracic Epidural Analgesia
Post Mastectomy
Pain Syndrome
Breast Cancer Patients
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: The average duration of analgesia
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: The total amount of morphine
timeFrame: 24 hours postoperatively
measure: Incidence of postmastectomy pain syndrome
timeFrame: 6 months postoperatively
measure: The total amount of fentanyl
timeFrame: Intraoperatively
measure: Heart rate (HR)
timeFrame: 24 hours Postoperatively
measure: Mean arterial blood pressure (MAP)
timeFrame: 24 hours Postoperatively
measure: Degree of pain
timeFrame: 24 hours Postoperatively
measure: Incidence of Postoperative nausea and vomiting (PONV).
timeFrame: 24 hours Postoperatively
measure: Complications related to the block
timeFrame: 6 months postoperatively
measure: Morphine-related complications
timeFrame: 24 hours Postoperatively
measure: Patient's satisfaction
timeFrame: 24 hours Postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
Study officials:
References: