Adding Magnesium Sulfate to Local Anesthetic in Combined Pectoral Nerve and Stellate Ganglion Block for Postoperative Pain Control After Modified Radical Mastectomy

Cairo University (CU)

Status: Enrolling

Conditions: Postoperative Pain; Stellate Ganglion Block; Pectoral Nerve; Local Anesthetic; Magnesium Sulfate; Modified Radical Mastectomy

Treatments: Drug: Bupivacaine; Drug: Bupivacaine + Magnesium sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT06815887

AP2311-201-091

Details and patient eligibility

About

We aim to study the effect of adding magnesium sulfate as an adjuvant to the local anesthetic used in the combined Pectoralis Nerve Block II (PECS II) and stellate ganglion block for postoperative pain control in patients undergoing modified radical mastectomy.

Full description

Post-operative pain from breast surgery can be controlled by regular pain medications such as paracetamol, non-steroidal anti-inflammatory (NSAIDs), and narcotics. Nerve blocks are commonly used as multimodal approaches for acute post-operative pain relief.

Pectoral and stellate ganglion blocks are regional anesthesia techniques that target the thoracic nerves and sympathetic nerve ganglia to provide analgesia for the upper extremity and chest regions. When combined, these blocks have shown promising results in alleviating perioperative pain for patients undergoing modified radical mastectomy.

Magnesium sulfate, a well-known adjuvant, has been studied extensively for its analgesic properties and anti-inflammatory effects.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years.
• Female gender.
• American Society of Anesthesiologists (ASA) physical status II or III.
• Patients scheduled for elective modified radical mastectomy for breast cancer.
• Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.

Exclusion criteria

• Bleeding tendency due to coagulopathy,
• Patients with opioid dependence or alcohol or drug abuse,
• Significant liver and renal sufficiency
• Patients with psychiatric illnesses that prevent them from proper perception and assessment of pain.
• Local infection at the site of the block.
• Known hypersensitivity or allergy to magnesium sulfate or local anesthetics.
• Patients with chronic pain syndromes or pre-existing neuropathic pain conditions.
• Pregnant or lactating individuals.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

70 participants in 2 patient groups

Group A

Active Comparator group

Description:

Patients will receive the combined pectoralis nerve block II (PECS II)(20 mL) and stellate ganglion block (5 mL) using 0.5% bupivacaine (local anesthetic) without magnesium sulfate.

Treatment:

Drug: Bupivacaine

Group B

Experimental group

Description:

Patients will receive the combined (20 mL) pectoralis nerve block II (PECS II) and stellate ganglion block (5 mL) using 0.5% bupivacaine (local anesthetic) mixed with 2.5 mL magnesium sulfate (10%), i.e., 250 mg.

Treatment:

Drug: Bupivacaine + Magnesium sulfate