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NCT Number: NCT06815887

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Bupivacaine

Drug

Patients received 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.

Bupivacaine + Magnesium sulfate

Drug

Patients received 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.

Primary outcomes

  1. Total morphine consumption

    Time frame: 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 outcomes

  1. Degree of pain

    Time frame: 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.

  2. Time to first request analgesia

    Time frame: 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.

  3. Incidence of adverse events

    Time frame: 24 hours postoperatively

    Incidence of adverse events such as nausea and vomiting will be recorded.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2025
Registry last updated
May 22, 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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