National Cancer Institute - Cairo University
Cairo, 11796, Egypt
Location status: Recruiting
Location contact
Asmaa Elsayed Khalil Elmoghazy, MD
CONTACT
Ayman Sharawy AbdelRahman Aboul Nasr, MSc
CONTACT
+201282649008 ext. 0020
NCT Number: NCT07390448
Acute post-mastectomy pain can cause adverse impacts on the patients as delayed discharge from post-operative recovery area, impairs pulmonary and immune functions, increases risk of ileus, thromboembolism, myocardial infarction and may lead to increased length of hospital stay. It is also an important factor leading to the development of chronic post mastectomy pain syndrome (PMPS) in almost half of the patients.
Various regional anesthetic techniques have been described for postoperative pain relief after mastectomy, for example, thoracic epidural anesthesia, intercostal nerve block, paravertebral block, serratus anterior plane block, and pectoral nerve I and II blocks. All of them offer satisfactory pain relief after mastectomy.
Erector spinae plane block is a novel para-spinal regional anesthesia technique, , promises to provide effective visceral as well as somatic analgesia after carcinoma of the breast surgeries.
The ultrasound-guided rhomboid intercostal block sub-serratus plane block (RISS) is a novel analgesic technique The RISS block anesthetizes the lateral cutaneous branches of the thoracic intercostal nerves and can be used in multiple clinical settings for chest wall and upper abdominal analgesia
Interested in participating?
Request Info18 year–60 year
Female
Interventional
Not applicable
Cairo, 11796, Egypt
Location status: Recruiting
Asmaa Elsayed Khalil Elmoghazy, MD
CONTACT
Ayman Sharawy AbdelRahman Aboul Nasr, MSc
CONTACT
+201282649008 ext. 0020
Breast cancer is the most common diagnosed malignancy among females and the 5th cause of cancer-related deaths with an estimated number of 2.3 million new cases and 685,000 deaths worldwide in 2020.
Different modalities are used for management of breast cancer including surgery, radiation therapy (RT), chemotherapy (CT), endocrine (hormone) therapy (ET), and targeted therapy. Modified Radical Mastectomy (MRM) is one of the main modalities of breast cancer treatment. It accounts for 31% of all breast surgeries. It has been reported that 40% of the females complain from moderate-to-severe pain in the immediate post-operative period after breast cancer surgery.
Acute post-mastectomy pain can cause adverse impacts on the patients as delayed discharge from post-operative recovery area, impairs pulmonary and immune functions, increases risk of ileus, thromboembolism, myocardial infarction and may lead to increased length of hospital stay. It is also an important factor leading to the development of chronic post mastectomy pain syndrome (PMPS) in almost half of the patients.
Various regional anesthetic techniques have been described for postoperative pain relief after mastectomy, for example, thoracic epidural anesthesia, intercostal nerve block, paravertebral block, serratus anterior plane block, and pectoral nerve I and II blocks. All of them offer satisfactory pain relief after mastectomy.
Erector spinae plane block is a novel para-spinal regional anesthesia technique, promises to provide effective visceral as well as somatic analgesia after carcinoma of the breast surgeries.
The ultrasound-guided rhomboid intercostal block (RIB) and rhomboid intercostal block sub-serratus plane block (RISS) are two novel analgesic techniques . Additionally, the RISS block anesthetizes the lateral cutaneous branches of the thoracic intercostal nerves and can be used in multiple clinical settings for chest wall and upper abdominal analgesia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound Guided Combined Rhomboid Intercostal Sub-serratus Plane Blocks
Erector Spinae Plane Block
Time frame: 24 hours after the surgery
The total 24-hour morphine consumption will be recorded for every patient post operative.
Time frame: 2-3 hours (Surgery time) surgery
the rescue analgesia will be administered intra-operative by fentanyl IV and the total fentanyl used will be recorded and compared between the groups
Time frame: 24 hours after the surgery
In case of postoperative pain recorded, rescue analgesia will be provided as IV morphine (3 mg) then continuous infusion of morphine through Patient Controlled Analgesia ( PCA ) to keep the VAS scores<3. The total 24-hour morphine consumption will be recorded for every patient.
Time frame: every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively
Change in Mean Arterial Blood Pressure (MAP) in mmHg
Time frame: every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively
Change in heart rate (HR) in beat\\min
Contact information is provided by the study sponsor or research team.
Asmaa Elsayed Khalil Elmoghazy, MD
CONTACT
01009468049 ext. 0020
Ayman Sharawy Abdelrahman Aboul Nasr, MD
CONTACT
01282649008 ext. 0020
National Cancer Institute, Egypt
Other
A Comparative Study Between Ultrasound Guided Combined Rhomboid Intercostal and Sub- Serratus Plane Blocks and Erector Spinae Plane Block as Perioperative Analgesia in Mastectomy Surgeries in Cancer Breast Patients
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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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