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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
combined Pecto-Intercostal- Serratus anterior fascial planes Block
Procedure/SurgeryPIFB 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
Trial outcomes
Primary outcomes
intravenous opioid consumption
total intravenous opioid consumption during the first 24 hours
Secondary outcomes
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
First request of analgesia.
first request of opioid analgesic
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
South Egypt Cancer Institute
Lead sponsor
Assiut University
Collaborator
This trial is not recruiting at the moment. You can still explore other options: