Comparing of 2 Different Volumes in ESPB in Patients Undergoing MRM
Conditions
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.
Interventions
DRUGGroup 1(low concentration-high volume bupivacaine US guided Erector Spinae Plane block)
Patients will preoperatively receive low concentration-high volume ultasound 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
DRUGGroup 2(high concentration-low volumecbupivacaine US guided Erector Spinae Plane block)
Patients will preoperatively receive high concentration-low volume ultasound 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 patien).
Sponsors
Yasmina sayed Abdrabo Ismael
Norhan Abdelaleem Ali
Ahmed Shaker Ragab
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
Patients will be randomly allocated to one of the two groups by sealed closed envelop technique
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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total dose of morphine needed postoperatively | Through Study Completion Up to 1 Day | Total dose of morphine needed postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total dose of fentanyl required intraoperative (including induction dose) | Through study completion,an average of 1day | Total dose of fentanyl required intraoperative (including induction dose) |
| Pain score at 15, 30, 45 and 60 min., 3,6,12 and 24 h after surgery | through study completion,an average of 1day | Pain score at 15, 30, 45 and 60 min., 3,6,12 and 24 h after surgery |
| Need for blood transfusion | Through Study Completion over the first 24 hours postoperative | Need for blood transfusion |
| Duration of surgery | Through Study Completion 24 hours postoperative | Duration of surgery |
| Blood loss, | Through Study Completion,an average of 1day | Blood loss, |
| Time to first rescue analgesia, starting after extubation | Through Study Completion over the first 24 hours postoperative | Time to first rescue analgesia, starting after extubation |
Countries
Egypt
Outcome results
None listed