An interventional study of combined Pecto-Intercostal- Serratus anterior fascial planes Block in Modified Radical Mastectomy, sponsored by South Egypt Cancer Institute. Not yet recruiting. Open to female participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-25.
Sponsored by South Egypt Cancer Institute · Not applicable, Interventional, and Treatment
Here, in our study, we intend to compare the analgesic efficacy of magnesium sulfate as an adjuvant to local anesthetics added to the Pecto-Intercostal Fascial Block (PIFB) vs the Serratus Anterior Plane Block (SAPB) in patients undergoing modified radical mastectomy.
Study Endpoints Primary Endpoints: Total intravenous opioid consumption during the first 24 hours following surgery. Secondary Endpoints: Postoperative analgesia, 24 hours after surgery, assessed using the Visual Analog Scale (VAS) and time to first analgesic request.
Modified radical mastectomy, a common surgical intervention for breast cancer therapy, and is often associated with extensive postoperative pain. Effective regional anesthesia techniques are important modalities to manage this pain and reduce total opioid consumption in the early postoperative phase. A few interfacial nerve block methods (for example, pectoral nerve blocks I and II and erector spinae plane block) are also utilized in some other procedures to reduce the postoperative pain. However, these methods require particular patient positioning.
A new, minimally-invasive technique called pecto-intercostal fascial plane block (PIFB) was firstly used by De la Torre in patients who had undergone breast surgery. The Pecto-Intercostal Fascial Block (PIFB) and the Serratus Anterior Plane Block (SAPB) have appeared as promising techniques for providing pain relief in breast surgeries. PIFB targets the anterior cutaneous branches of the intercostal nerves, while SAPB focuses on the lateral cutaneous branches, each offering distinct anatomical coverage. Some specific benefits have been reported when using PIFB such as less invasiveness, proximity to the incision line, and postoperative administration with no specific patient positioning.
Recent studies have examined the efficacy of adding adjuvants to local anesthetics. Magnesium sulfate, known for its NMDA receptor antagonism and calcium channel blocking properties, has been investigated for its potency to prolong pain relief and improve analgesic control when used as an adjuvant in peripheral blocks. Evaluating the efficacy of magnesium sulfate in these fascial plane blocks may lead to the establishment of an improved standard of care in postoperative pain management.
While both PIFB and SAPB are considered safe and relatively easy to perform using ultrasound, comparative data regarding their efficacy, especially with magnesium sulfate as an adjuvant, remains limited. The outcomes of this study may help define a more effective and standardized analgesic approach for patients undergoing modified radical mastectomy. Furthermore, minimizing systemic opioid requirements is especially gaining interest considering current efforts to reduce opioid-related side effects and dependence in surgical patients.
Here, in our study, we intend to compare the analgesic efficacy of magnesium sulfate as an adjuvant to local anesthetics added to the Pecto-Intercostal Fascial Block (PIFB) vs the Serratus Anterior Plane Block (SAPB) in patients undergoing modified radical mastectomy.
Study Endpoints
Exclusion Criteria:
patients will receive the combined Pecto-Intercostal- Serratus anterior fascial planes Block with a total volume of 30 mL local anesthetic; 15 ml per block (13.5 ml Bupivacaine 0.25% + 1.5 ml normal saline for each block).
Procedure: combined Pecto-Intercostal- Serratus anterior fascial planes Block
where patients will receive the combined Pecto-Intercostal- Serratus anterior fascial planes block with a total of 30 ml local anesthetic volume; 15 ml per block (13.5ml bupivacaine 0.25% + 1.5 ml MgSo4 10% (100 mg/ml))
Procedure: combined Pecto-Intercostal- Serratus anterior fascial planes Block
PIFB will be performed using a high-frequency linear ultrasound probe. probe should be inserted 2 cm laterally from the sternum and parallel to it. The Pecto-Intercostal Fascial plane is located between the pectoralis major muscle and the external intercostal muscle, or the costal cartilage. A 22 G 80 mm needle will be inserted under the pectoralis major and above the external intercostal muscle using the in-plane approach. Additionally, a test bolus of saline (2 mL) will be given. For SAPB approach, patients will be positioned to the supine, and the injection sites are sterilized. The ipsilateral arm will be abducted at 90°. A high-frequency linear USG probe will be placed on the mid-axillary line in the axilla. Using an in-plane technique, a 100-mm block needle will be advanced caudo-cranially between the serratus anterior muscle and the fifth rib. After negative aspiration 1-2 mL of saline will be injected as a test dose.
Also known as: Ultrasound guided PIFB - SAPB approach
intravenous opioid consumption
total intravenous opioid consumption during the first 24 hours
Time frame: 24 hours postoperatively
pain intensity postoperatively at rest and during pain-provoking movements
postoperative pain intensity at rest and during pain-provoking movements (deep breathing, coughing, mobilization) measured by Visual analogue scale where 0= no pain, 10= worst imaginable pain
Time frame: 24 hours postoperatively
First request of analgesia.
first request of opioid analgesic
Time frame: 24 hours postoperatively
No study locations are listed for this record.
Plan to share: No
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South Egypt Cancer Institute