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

NCT07434232 | Not Yet Recruiting DMC

• 1 other identifier: 18-2026-810
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Modified Radical Mastectomy

Outcome Measures

Primary Outcomes (1)

• intravenous opioid consumption

  total intravenous opioid consumption during the first 24 hours

  24 hours postoperatively

Secondary Outcomes (2)

• pain intensity postoperatively at rest and during pain-provoking movements

  24 hours postoperatively

• First request of analgesia.

  24 hours postoperatively

Study Arms (2)

(Control group):

SHAM COMPARATOR

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

(Magnesium group).:

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Ultrasound guided PIFB - SAPB approach

(Control group):; (Magnesium group).:

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• South Egypt Cancer Institute: lead
• Assiut University: collaborator

Central Study Contacts

mohamed fa abd elhamed, lecture

CONTACT

01015249890; m.farghaly.na@gmail.com

bahaa ga saad, lecturer

CONTACT

01003644592

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: n online randomization program (http://www.randomizer.org) will be used to generate a random list and each patient's code will be kept in an opaque sealed envelope. Patients will be randomly allocated with 1:1 allocation ratio into two equal groups in a parallel manner:Patients and outcome assessors will be blinded to the study groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia

Model Details: Participants were randomly assigned to two groups: Group I (Control group): 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). Group II (Magnesium group).: 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))

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 25, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 15, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share