Adding Magnesium Sulfate to Combined Pecto-Intercostal & Serratus Anterior Planes Block on Post-operative Analgesia in Patients Undergoing Modified Radical Mastectomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-75
SponsorSouth Egypt Cancer Institute

About this trial

Here, in our study, we intend to compare the analgesic efficacy of magnesium sulfate as an adjuvant to local anesthetics added to the Pecto-Intercostal Fascial Block (PIFB) vs the Serratus Anterior Plane Block (SAPB) in patients undergoing modified radical mastectomy.

Study Endpoints Primary Endpoints: Total intravenous opioid consumption during the first 24 hours following surgery. Secondary Endpoints: Postoperative analgesia, 24 hours after surgery, assessed using the Visual Analog Scale (VAS) and time to first analgesic request.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged 30 to 75 years diagnosed with non-metastatic breast cancer and scheduled for modified radical mastectomy.

ASA, I-III and NYHA, I-II.

Written informed consent.

Disqualifiers

ASA physical status >III and NYHA >II,

body mass index >40 kg/m2,

pregnant women,

Patients with organ failure or coagulation disorders.

Trial design

Design model

Parallel

Treatments tested in this trial

  • combined Pecto-Intercostal- Serratus anterior fascial planes Block

    Procedure/Surgery

    PIFB will be performed using a high-frequency linear ultrasound probe. probe should be inserted 2 cm laterally from the sternum and parallel to it. The Pecto-Intercostal Fascial plane is located between the pectoralis major muscle and the external intercostal muscle, or the costal cartilage. A 22 G 80 mm needle will be inserted under the pectoralis major and above the external intercostal muscle using the in-plane approach. Additionally, a test bolus of saline (2 mL) will be given. For SAPB approach, patients will be positioned to the supine, and the injection sites are sterilized. The ipsilateral arm will be abducted at 90°. A high-frequency linear USG probe will be placed on the mid-axillary line in the axilla. Using an in-plane technique, a 100-mm block needle will be advanced caudo-cranially between the serratus anterior muscle and the fifth rib. After negative aspiration 1-2 mL of saline will be injected as a test dose.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: (Control group):Sham comparator 1 intervention
Group B: (Magnesium group).:Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

intravenous opioid consumption

total intravenous opioid consumption during the first 24 hours

Time frame
24 hours postoperatively

Secondary outcomes

1

pain intensity postoperatively at rest and during pain-provoking movements

postoperative pain intensity at rest and during pain-provoking movements (deep breathing, coughing, mobilization) measured by Visual analogue scale where 0= no pain, 10= worst imaginable pain

Time frame
24 hours postoperatively
2

First request of analgesia.

first request of opioid analgesic

Time frame
24 hours postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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South Egypt Cancer Institute

Lead sponsor

Assiut University

Collaborator

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