Adding Magnesium Sulfate to Combined Pecto-Intercostal & Serratus Anterior Planes Block on Post-operative Analgesia in Patients Undergoing Modified Radical Mastectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: combined Pecto-Intercostal- Serratus anterior fascial planes Block.
- Who it may be relevant to
- Registry conditions: Modified Radical Mastectomy. Basic parameters: 30 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Adding Magnesium Sulfate to Combined Pecto-Intercostal & Serratus Anterior Planes Block on Post-operative Analgesia in Patients Undergoing Modified Radical Mastectomy: A Prospective, Randomized Controlled Clinical Trial
Overview
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.
Detailed description
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
Interventions
- 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 app
Primary outcome measures
- intravenous opioid consumption [Time frame: 24 hours postoperatively]
Secondary outcome measures (2)
- pain intensity postoperatively at rest and during pain-provoking movements [Time frame: 24 hours postoperatively]
- First request of analgesia. [Time frame: 24 hours postoperatively]
Eligibility criteria
Inclusion criteria
- Female patients aged 30 to 75 years diagnosed with non-metastatic breast cancer and scheduled for modified radical mastectomy.
- ASA, I-III and NYHA, I-II.
- Written informed consent.
Exclusion criteria
- ASA physical status >III and NYHA >II,
- body mass index >40 kg/m2,
- pregnant women,
- Patients with organ failure or coagulation disorders.
- Allergy to local anesthetics or magnesium sulfate
- Contraindications as local infection
- History of chronic pain or opioid use .
- Unwilling to participate in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07434232 · 18-2026-810