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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2025-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

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.

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type 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 B

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 Type EXPERIMENTAL

Bupivacaine + Magnesium sulfate

Intervention Type 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.

Interventions

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Bupivacaine

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.

Intervention Type DRUG

Bupivacaine + Magnesium sulfate

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No