National Cancer Institute - Cairo University
Cairo, 11796, Egypt
Location status: Recruiting
Location contact
Ayman Sharawy AbdelRahman Aboul Nasr, MD
CONTACT
+201282649008 ext. 0020
Yousr Farag Abdelhamid, MSc
CONTACT
NCT Number: NCT07650305
Breast cancer remains the most frequently diagnosed cancer and a major cause of cancer-related mortality among women worldwide. Modified radical mastectomy (MRM), a common surgical procedure for breast cancer, is associated with significant postoperative pain, which may delay recovery and contribute to the development of chronic postmastectomy pain syndrome (PMPS). To address this, regional anesthesia techniques have been increasingly incorporated into multimodal analgesia strategies to reduce opioid consumption and enhance patient outcomes. Interfascial plane blocks, in particular, offer safe and effective analgesia under ultrasound guidance. The erector spinae plane block (ESPB), first described in 2016, involves injection of local anesthetic deep to the erector spinae muscle and may spread to the paravertebral space, providing both somatic and visceral analgesia. A bilevel approach may enhance dermatomal coverage. Meanwhile, the pectoserratus plane block (PSPB), which combines PECS II and serratus anterior blocks, targets nerves of the anterior and lateral chest wall and has shown efficacy in breast surgery
Interested in participating?
Request Info18 year–65 year
Female
Interventional
Not applicable
Cairo, 11796, Egypt
Location status: Recruiting
Ayman Sharawy AbdelRahman Aboul Nasr, MD
CONTACT
+201282649008 ext. 0020
Yousr Farag Abdelhamid, MSc
CONTACT
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.
The erector spinae plane block (ESPB), first described in 2016, involves injection of local anesthetic deep to the erector spinae muscle and may spread to the paravertebral space, providing both somatic and visceral analgesia. A bilevel approach may enhance dermatomal coverage. Meanwhile, the pectoserratus plane block (PSPB), which combines PECS II and serratus anterior blocks, targets nerves of the anterior and lateral chest wall and has shown efficacy in breast surgery
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound guided bilevel Erector spinae plane block
ultra sound guided combined Pectoral Nerve (PECS II) Block and Serratus anterior (SAPB) 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
Time frame: 24 hours after the surgery
Pain scores using Visual analogue score (VAS) (0 mm = no pain to 10mm = worst pain imaginable) at predetermined time intervals (1, 2, 6, 12 and 24h) postoperative.
Contact information is provided by the study sponsor or research team.
Ayman Sharawy Abdelrahman Aboul Nasr, MD
CONTACT
01282649008 ext. 0020
Yousr Farag Abdelhamid, MSc
CONTACT
National Cancer Institute, Egypt
Other
Bilevel Erector Spinae Plane Block Versus Pecto-serratus Block for Analgesia in Modified Radical Mastectomy in Cancer Surgery
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
Published trials that share one or more normalized conditions with this study.
NCT04816006
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Phoenix, Arizona, United States
View Trial DetailsNCT05625659
Breast Cancer, Breast Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT06954337
Breast Cancer, Breast Diseases
Basking Ridge, New Jersey, United States
View Trial DetailsNCT07340541
Breast Cancer, Breast Diseases
Baltimore, Maryland, United States
View Trial Details