Perioperative Analgesic Effect of Two Different Volumes of Local Anesthetic Solution in Erector Spinae Plane Block in Patients Undergoing Modified Radical Mastectomy

Cairo University (CU)

Status: Completed

Conditions: Erector Spinae Plane Block; Modified Radical Mastectomy

Treatments: Drug: Erector spinae plane block (15 ml bupivacaine 0.5% and 15ml normal saline); Drug: Erector spinae plane block(15 ml bupivacaine 0.5%)

Study type: Interventional

Funder types: Other

Identifiers

NCT06498739

MS-520-2022

Details and patient eligibility

About

Comparing the perioperative analgesic effect of two different volumes of local anesthetic solution in erector spinae plane block in patients undergoing modified radical mastectomy. A randomized comparative study.

Full description

Breast cancer is the most common malignancy among females with incidence of about 2.1 million women each year. Modified Radical Mastectomy (MRM) is one of the main surgical treatments of breast cancer.

Pain can be severe enough to cause long-term disabilities and interfere with sleep and performance of daily activities . Multiple regional techniques have been developed in recent years for postoperative analgesia of breast surgery inkling erector spinae plane block (ESPB) aiming to be effective and associated with less complications when compared to the gold standard techniques (thoracic epidural analgesia or paravertebral block). Ultrasound guided erector spinae plane block (ESPB) was described in 2016 as a novel regional anesthetic technique for acute and chronic thoracic pain, it has been used as a regional anesthetic technique for breast surgery based on case reports and case series. It is a paraspinal fascial plane block that involves injection of local anesthetic deep in the erector spinae muscle and superficial to the tips of the thoracic transverse processes. The site of injection is distant from the pleura, major blood vessels, and spinal cord.

Enrollment: 52 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age from 18 to 60 years.
• Genders eligible for study: female sex.
• American Society of Anesthesiologists (ASA) I-II.
• Undergoing modified radical mastectomy.
• Body mass index (BMI) from 18.5 to 30 kg.

Exclusion criteria

• Patient refusal.
• Known allergy to local anesthetics .
• Bleeding disorders; platelets count <50,000 ,prothrombin concentration < 60% or any coagulopathy disorder.
• Use of any anti-coagulants .
• Inability to provide informed consent.
• Neurological disorders.
• Patient with psychiatric disorders.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

Erector Spinae Plane block (high concentration-low volume)

Other group

Description:

Patients will preoperatively receive high concentration-low volume ultrasound guided Erector Spinae Plane block, and then the patient will be transferred to the operating room (one syringe of 15 ml bupivacaine 0.5% {15 ml bupivacaine 0.5% }, for each patient).

Treatment:

Drug: Erector spinae plane block(15 ml bupivacaine 0.5%)

Erector Spinae Plane block (low concentration-high volume)

Other group

Description:

Patients will preoperatively receive low concentration-high volume ultrasound guided Erector Spinae Plane block, and then the patient will be transferred to the operating room ) one syringe of 30ml bupivacaine 0.25% {15 ml bupivacaine 0.5% and 15ml normal saline}, for each patient.

Treatment:

Drug: Erector spinae plane block (15 ml bupivacaine 0.5% and 15ml normal saline)