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Compares treatment options for Ultrasound
Official title Ultrasound-guided Multilevel Erectorspinae Plane Block Versus Thoracic Epidural Analgesia for Prevention of Post Mastectomy Pain Syndrome for Breast Cancer Patients
ClinicalTrials.gov ID: NCT06884852
What this study is testing
What is Erector spinae plane block (ESPB)?
Erector spinae plane block (ESPB) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for ultrasound.
Also referred to as Bupivacaine 0.25%.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65, women only
You may be able to join if
- 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.
You likely can't join if
- 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...
See the full eligibility 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.
- 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...
- 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...
- 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...
- Severe lung disease which includes oxygen saturation of blood less than 92%, RR more than 20, FEV1/FVC ratio less than 60%.
- Pregnancy.
The study team makes the final eligibility decision.
Where it's taking place
- Cairo, Egypt
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cairo, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.