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NCT Number: NCT07434232

Adding Magnesium Sulfate to Combined Pecto-Intercostal & Serratus Anterior Planes Block on Post-operative Analgesia in Patients Undergoing Modified Radical Mastectomy

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.

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Key information

Age range

30 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

combined Pecto-Intercostal- Serratus anterior fascial planes Block

Procedure

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.

Other names: Ultrasound guided PIFB - SAPB approach

Primary outcomes

  1. intravenous opioid consumption

    Time frame: 24 hours postoperatively

    total intravenous opioid consumption during the first 24 hours

Secondary outcomes

  1. pain intensity postoperatively at rest and during pain-provoking movements

    Time frame: 24 hours postoperatively

    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

  2. First request of analgesia.

    Time frame: 24 hours postoperatively

    first request of opioid analgesic

Study contacts

Contact information is provided by the study sponsor or research team.

bahaa ga saad, lecturer

CONTACT

01003644592 ext. 02

mohamed fa abd elhamed, lecture

CONTACT

[email protected]

01015249890 ext. 02

Sponsors and collaborators

Lead sponsor

South Egypt Cancer Institute

Other

Collaborators

  • Assiut University

Registry information

Official study 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

Acronym: Mastectomy

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

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.

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