Faculty of medicine, Tanta university
Tanta, El Gharbyia, 31111, Egypt
NCT Number: NCT06533566
This randomized prospective double blinded study will aim to evaluate the postoperative analgesic effect of ultrasound guided Erector Spinae plane block and local wound infiltration (drain block) for patients scheduled for modified radical mastectomy surgery.
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Notify Me18 year–60 year
Female
Interventional
Not applicable
Tanta, El Gharbyia, 31111, Egypt
Breast cancer is the most commonly diagnosed cancer worldwide and it represents 1 in 4 cancers diagnosed among women globally. Modified Radical Mastectomy (MRM) is a commonly performed surgery for breast cancer and is associated with moderate-to-severe postoperative pain. Poor postoperative pain management can lead to increased chances of the development of chronic pain. Therefore, adequate postoperative pain management after breast cancer surgery is essential. Regional block for pain management has many advantages in such patients including provision of adequate analgesia, reduced need for opioids, decreased postoperative nausea & vomiting and postoperative pulmonary complications. It also facilitates early ambulation. Thoracic Epidural (TE), paravertebral block (PVB), pectoral nerve I & pectoral nerve II blocks, serratus anterior plane block and erector spinae plan block have been used with good results. In particular, the erector spinae has proven to reduce pain severity and opioid consumption in this group of patients. Further, in meta-analysis, the ESP block was shown to effectively alleviate postoperative pain severity and reduce opioid consumption. In ESP block, local anesthetic is deposited deep to the erector spinae muscle which results in blocking of the ventral and dorsal rami of multiple spinal nerves. The LA diffuses into the paravertebral space and cephalo-caudally and blocks the pain by action on dorsal rami, ventral rami, and lateral cutaneous branches of intercostal nerves. Also, in many situations, a superior postoperative analgesia yet avoiding the detrimental effects of opioids, can be extracted from a simple technique of wound instillation of local anesthetics through surgical drain which provide a satisfactory long opioid free postoperative analgesic period.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patients will be placed in the lateral decubitus position. The ESP block is usually performed at the level of fourth transvers process. The ultrasound probe should be placed in a cephalo-caudal orientation over the midline of the back at the desired level.Under aseptic conditions, the block needle will be inserted in plane at an angle of 30-40° in cranial-to-caudal direction until the tip contacted the T4 transverse process at erector spinae plane. After hydro-dissection with 2-3 mL of isotonic saline solution to confirm the correct needle tip position and after negative aspiration to prevent intra vascular injection or position, (20 ml) of plain bupivacaine 0.25% will be injected deep to the erector spinae muscle.
after the surgeon complete the surgery and insert the surgical drains (pectoral and axillary drains) we will inject 20ml of plain bupivacaine 0.25% in each surgical drain, the drains will be clamped for 20 minutes then declamped.
Other names: drain block
Time frame: first postoperative day after modified radical mastectomy surgery
total morphine amount which will be consumed in the first postoperative day
Tanta University
Other
Effect of Erector Spinae Plane Block Versus Local Wound Infiltration on Postoperative Pain After Modified Radical Mastectomy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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