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

NCT06815887 | Recruiting

• 1 other identifier: AP2311-201-091
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  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.

  24 hours postoperatively

Secondary Outcomes (3)

• Degree of pain

  24 hours postoperatively

• Time to first request analgesia

  24 hours postoperatively

• Incidence of adverse events

  24 hours postoperatively

Study Arms (2)

Group A

ACTIVE COMPARATOR

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.

Drug: Bupivacaine

Group B

EXPERIMENTAL

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.

Drug: Bupivacaine + Magnesium sulfate

Interventions

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.

Group A

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.

Group B

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Mahmoud A Ali, Master

CONTACT

00201096799233; dr.ambitious2@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist of Anesthesia, Intensive Care Unit and Pain Relief

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: February 10, 2025
• Study Start: January 15, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of the study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)