Clinical trial NCT06404918: Preemptive Erector Spinae Plane Block Versus Serratus Anterior Plane Block in MRM
Official title: Comparison Between Preemptive Erector Spinae Plane Block Versus Serratus Anterior Plane Block on Postoperative Analgesia for Patients Undergoing Modified Radical Mastectomy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Modified Radical Mastectomy
Keywords: Erector Spinae Plane Block
Serratus Anterior Plane Block
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group I (35 patients): patients received US ESPB and group II (35 patients): patients received USAPB.
Primary purpose: PREVENTION

Brief summary: Modified radical mastectomy (MRM) is one of the most performed surgeries for breast cancer. MRM is associated with significant pain during the immediate postoperative period.

Detailed description: Modified radical mastectomy (MRM) is one of the most performed surgeries for breast cancer. MRM is associated with significant pain during the immediate postoperative period.

Inadequate pain management has both psychological and physiological repercussions.

Various local or regional nerve blocks like thoracic epidural, interscalene brachial plexus, paravertebral, pectoral nerve blocks, and erector spinae plane blocks are performed in MRM to provide analgesia.

Ultrasound-guided Erector spinae plane block (USG-ESPB) is one of the novel and effective regional techniques where local anaesthetic is deposited deep into the erector spinae muscle, blocking the ventral and dorsal rami of multiple spinal nerves, and is technically simple, with fewer hemodynamic side effects and with minimal complications

Eligibility criteria: Inclusion Criteria:

* female patients
* aged from 18 to 70 years
* with a body mass index ≤ 30 kg/ m2
* American Society of Anesthesiologists (ASA) physical status I-II,
* who were scheduled for MRM for breast cancer

Exclusion Criteria:

* history of drug allergy,
* psychiatric illness, substance abuse,
* severe cardiovascular or respiratory disease,
* any pre-existing liver disease, metabolic or neurological syndrome, c

Primary outcomes:
measure: time of the first rescue analgesic dose
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Heart rate changes
timeFrame: 15 minutes after performing the block, and then every 30 minutes intraoperatively till the end of surgery, then postoperatively at 1hour and 2 hours, 4hours, 8hours, 12hours, 18hours, 24hours postoperatively.
measure: Mean arterial pressure changes
timeFrame: 15 minutes after performing the block, and then every 30 minutes intraoperatively till the end of surgery, then postoperatively at 1hour and 2 hours, 4hours, 8hours, 12hours, 18hours, 24hours postoperatively.
Other outcomes:
Locations:
city: Banha
country: Egypt
facility: Benha University
Study officials:
affiliation: Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt
name: Ramy Saleh, MD
role: PRINCIPAL_INVESTIGATOR
References: