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

Not Applicable

Recruiting

• Conditions: Local Anesthetic; Pectoral Nerve; Postoperative Pain; Modified Radical Mastectomy; Magnesium Sulfate; Stellate Ganglion Block
• Interventions: Drug: Bupivacaine + Magnesium sulfate; Drug: Bupivacaine

• Registration Number: NCT06815887
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2024-01-15
• Status Verified: 2025-02
• Study First Submitted: 2025-02-01
• Study First Submitted QC: 2025-02-04
• Last Update Submitted: 2025-02-04
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Bupivacaine + Magnesium sulfate	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.
Group A	Bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
Total morphine consumption	24 hours postoperatively	With numeric rating scale (NRS) rest score ≥ 3 or NRS evoked score ≥ 4, morphine will be administered intravenously by a dose of 0.05 mg/kg at 30-minute intervals until NRS rest score \< 3 or NRS evoked score \< 4.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	24 hours postoperatively	Incidence of adverse events such as nausea and vomiting will be recorded.
Degree of pain	24 hours postoperatively	The severity of pain will be assessed postoperatively using a numeric rating scale (NRS) both at rest and evoked (0 = no pain and 10 = worst imaginable pain). NRS will be recorded at 1, 2, 4, 6, 8, 10, 12, and 24 hours postoperatively.
Time to first request analgesia	24 hours postoperatively	The time to first request analgesia will be recorded from the end of surgery till the first dose of morphine is administrated.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt