Breast Cancer, Modified Radical Mastectomy
Conditions
Keywords
Breast Cancer, Modified Radical Mastectomy, Peripheral Nerve Block, Dexmedetomidine, Erector Spinae Plane Block, Serratus Anterior Plane Block, Ultrasound Guided, Adult Female
Brief summary
The goal of this clinical trial is to compare Ultrasound Guided Erector Spinae and Ultrasound Guided Serratus Anterior Plane Block post Modified Radical Mastectomy in adult females. the main questions it aims to answer are: * Which of the two blocks has a better analgesic effect? * Which of the two blocks is safer as regards inducing a pneumothorax and affecting the hemodynamics? Participants: * Will be divided into two groups after signing the informed consent. * After being anesthetized and before surgical incision; the blocks will be given to the patient. * Lung Ultrasound will be done for each patient to rule out pnemothorax once before the surgery and another after the end of surgery while the patient is being anesthetized. * Patients that will experience pneuomothorax will be excluded from the study, and will be treated according to its size. * Follow up of the patient for 24 hours postoperative to record the VAS score continuously, with giving increments of pethidine intravenously to relief pain.
Detailed description
Breast surgeries belong to the most frequently performed procedures and are often associated with a high intensity of pain in the postoperative period. Regional anesthesia techniques, have been the gold standard of postoperative pain management for breast surgeries. In recent years, the development of new techniques of regional anesthesia, which is due to the extensive implementation of ultrasound imaging, has enabled the use of a number of new blockades.The core mechanism of action in fascial blocks consists of blocking the nerve structures that supply a certain area of the trunk after deposition of local anesthetic within the fascial and fasciomuscular compartments. According to the current state of knowledge, the available options include Erector spinae plane block (ESPB) and Serratus anterior plane block (SAPB), however their recommendation in breast surgery requires more extensive scientific evidence. Serratus anterior plane block acts on lateral branches of the intercostals nerves, blocking pain reception in the chest wall, while Erector spinae plane block involves the deposition of local anesthetic in the interfascial plane between erector spinae muscle and tips of the transverse processes of the vertebrae. There is a scarcity of literature comparing ESPB and SAPB in patients undergoing breast surgeries. Proponents of these techniques champion their ability to provide efficacious analgesia and anesthesia whereas critics cite a reportedly high failure rate and complications such as pneumothorax. The German S3-guidelines suggest Lung Ultrasound as a possible alternative to Chest X-ray for the diagnosis of post-interventional pneumothorax. Dexamedetomidine is a highly selective drug α2-adrenergic receptor agonist. Dexmedetomidine has the characteristics of sedation, analgesia, anti-anxiety, inhibition of sympathetic activity, mild respiratory inhibition, and stable hemodynamics. Numerous studies has revealed that dexmedetomidine in peripheral nerve blocks can shorten the onset time of anesthesia and prolong the time of sensory and motor nerve blocks.
Interventions
PROCEDUREUnilateral Erector Spinae group
On injecting 30 ml of bupivacaine 0.25% with 20 mcg Dexamedetomidine into the interfacial plane below erector spinae; a manifest linear pattern will be visualized uplifting the muscle.
PROCEDUREUnilateral Serratus Anterior group
Once the needle will be in perfect position, confirmed by hydro-dissection on injecting 2-3 ml of normal saline, then 30 ml of bupivacaine 0.25% with 20 mcg Dexamedetomidine.
Sponsors
Kholoud Usama
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Sampling method will be simple random. Patients will be randomly assigned into one of the following groups using opaque sealed envelopes: 1. Group A (50 patients); will receive ultrasound guided Erector Spinae Plane Block. 2. Group B (50 patients); will receive ultrasound guided Serratus Anterior Plane Block.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* ASA Physical Status II, or III. * Age 21 - 65 years. * Female gender
Exclusion criteria
* ASA IV, V, VI. * Infection at site of block. * Coagulopathy, or patients on antiplatelets, or anticoagulants. * Previous anesthetic allergy to bupivacaine. * Distant organ metastasis. * Male gender.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Score for pain | at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively | * After extubation, the patient will be discharged from the operating room. VAS will be used to assess the postoperative pain (Myles et al., 2017). * Visual analogue scale score: Grade 0 (0-1 units on a scale): Good analgesia. Grade I (2-4 units on a scale): Moderate analgesia Grade II (5-7 units on a scale): Mild analgesia Grade III (8-10 units on a scale): No analgesia. * If VAS \>3 units on a scale postoperatively, IV increment of pethidine 30 mg diluted in 5 ml saline will be given. * VAS ranging from (0 units on a scale) no pain, to (10 units on a scale) severe intolerable pain; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total dose of pethidine in mg. | at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively | If VAS \>3 units on a scale postoperatively, IV increment of pethidine 30 mg diluted in 5 ml saline will be given. |
| Duration of analgesia postoperatively in hours. | at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively | If VAS \>3 units on a scale postoperatively, IV increment of pethidine 30 mg diluted in 5 ml saline will be given. |
| Rate of vital data changes over the postoperative period | every 2 hour during the first 6 hours and then every 6 hours for 24 hours postoperatively. | HR and MBP will be measured upon arrival to the PACU and after 30 min, then every hour if the patients remain in the PACU. In the surgical ward, vital signs (HR, SBP, MBP, DBP) as well as pain intensity will be assessed every 2 hour during the first 6 hours and then every 6 hours for 24 hours postoperatively. |
| Incidence of pneumothorax | Intra-operatively | * Measurement tool: Lung ultrasound * After giving the block in each group, Lung Ultrasound will be performed on patients in the supine body position. The transducer will be placed longitudinally at the highest point of the anterior thorax, then moved along the intercotal spaces of the parasternal line and laterally, between the anterior and posterior axillary line, checking for lung sliding and lung point in 2D B-mode, and for seashore or stratosphere sign in M-mode. The hemithorax without intervention was examined first and then compared to the hemithorax with intervention. * The Lung Ultrasound will be repeated after the end of the surgery, while the patient is anesthetized, and before extubation. Cases of pneumothoraces either large or small will be excluded from the study. |
Countries
Egypt
Outcome results
None listed