Clinical trial NCT05813158: Comparing the Perioperative Analgesic Effect of Two Different Volumes of Local Anesthetic Solution in Erector Spinae Plane Block in Patients Undergoing Modified Radical Mastectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Comparing of 2 Different Volumes in ESPB in Patients Undergoing MRM
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Yasmina sayed Abdrabo Ismael
name: Norhan Abdelaleem Ali
name: Ahmed Shaker Ragab
First posted: 2023-04-14
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We hypothesize that high volume low concentration ultrasound-guided Erector Spinae Plane block is going to be more effective than low volume high concentration in patients undergoing MRM. Many authors advocate increasing the volume of injection in fascial plane blocks to allow better spread of local anesthetic according to multiple studies
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to compare and evaluate the analgesic effects of ultrasound-guided Erector Spinae Plane block using low volumes and high concentrations versus high volumes and low concentrations in patients undergoing MRM.

Detailed description: Multiple regional techniques have been developed in recent years for postoperative analgesia of breast surgery including 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 (ESPB) block 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; hence, performing the ESPB has relatively few contraindications. The injected local anesthetic drug blocks the ventral and dorsal rami of spinal nerves on the paravertebral area .

Multiple studies have reported improved efficiency of interfascial blocks by increasing the volume of injection promoting better spread of local anesthesia. According to the authors best knowledge there is no studies comparing different volumes and concentration in ESPB in patients undergoing MRM This study aims to see the effect of fixing the drug mass of anaesthetic given in both groups, while altering the concentration of the anesthetic and total volume administered. One group will receive a lower concentration and higher volume, while the other will receive a higher concentration and lower volume.

Eligibility criteria: Inclusion Criteria:

Age starting from 18 to 60 years.

* Genders eligible for study: female sex.
* ASA II-III.
* Patients undergoing modified radical mastectomy.
* Body mass index (BMI) from 18.5 to 30 kg/m2.

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
* ASA IV
* Neurological disorders
* Patient with psychiatric disorders

Primary outcomes:
measure: Total dose of morphine needed postoperatively
timeFrame: Through Study Completion Up to 1 Day
Secondary outcomes:
measure: Time to first rescue analgesia, starting after extubation
timeFrame: Through Study Completion over the first 24 hours postoperative
measure: Duration of surgery
timeFrame: Through Study Completion 24 hours postoperative
measure: Blood loss,
timeFrame: Through Study Completion,an average of 1day
measure: Total dose of fentanyl required intraoperative (including induction dose)
timeFrame: Through study completion,an average of 1day
measure: Pain score at 15, 30, 45 and 60 min., 3,6,12 and 24 h after surgery
timeFrame: through study completion,an average of 1day
measure: Need for blood transfusion
timeFrame: Through Study Completion over the first 24 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Abdalla Mohamed
Study officials:
affiliation: Cairo University
name: Ahmed Abdalla Mohamed, M.D
role: PRINCIPAL_INVESTIGATOR
References: