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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:
Participants:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unilateral Erector Spinae group | Active Comparator | -The patient will be turned to the lateral decubitus position and the surgical side superiorly. After proper sterilization; The linear probe will be put in a parasagittal plane over the transverse process of thoracic 4 or thoracic 5 vertebrae, approximately 2.5 cm lateral to the spinous processes. The transverse process has a square form contour as compared to the rib which is rounded form contour. Then the 3 muscle layers or sheets with facial plane are distinguished from superficial to deep as trapezius, rhomboid major, and erector spinae with flickering pleura in between the transverse processes. The block will be managed unilaterally by in-plane technique using 22-gauge, 50 mm, echogenic needle which will be inserted in a cranial-caudal orientation and the block needle will be proceeded through the trapezius, rhomboid major, and erector spinae to smoothly contact the transverse process. Needle location will be confirmed by hydro-dissection on injecting 2-3 ml normal saline. |
|
| Unilateral Serratus Anterior group | Active Comparator | -After skin sterilization, with the patient in the lateral decubitus position and the side of surgery superiorly, the ultrasound linear probe will be put longitudinally oblique just below the mid-clavicle. After distinguish the second rib, the probe will be mobilized caudally and laterally (obliquely), towards the mid-axillary line to distinguish the third, fourth and fifth ribs. The ideal and definite probe position has its cephalad end at the anterior axillary line and the caudal end at the posterior axillary line. The facial plane between the serratus anterior muscle and ribs four and five will be identified between the 4th and 5th rib in the mid-axillary region. Under sonar guided, 50 mm echogenic needle will be advanced in-plane to introduce this facial plane in cranio-caudal direction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unilateral Erector Spinae group | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Score for pain |
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.
| at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Total dose of pethidine in mg. | If VAS >3 units on a scale postoperatively, IV increment of pethidine 30 mg diluted in 5 ml saline will be given. | at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively |
| Duration of analgesia postoperatively in hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Ain-Shams University | Recruiting | Cairo | Waili | 0000 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37220544 | Background | Chen Z, Liu Z, Feng C, Jin Y, Zhao X. Dexmedetomidine as an Adjuvant in Peripheral Nerve Block. Drug Des Devel Ther. 2023 May 17;17:1463-1484. doi: 10.2147/DDDT.S405294. eCollection 2023. | |
| 38741901 | Background | Abd Elmohsen Bedewy A, Mohamed MS, Sultan HM, Khalil MS. Comparison Between Erector Spinae Plane Block versus Serratus Anterior Plane Block Regarding Analgesia and Stress Response After Modified Radical Mastectomy: Randomized Controlled Trial. Anesth Pain Med. 2024 Mar 26;14(2):e142189. doi: 10.5812/aapm-142189. eCollection 2024 Apr. |
| Label | URL |
|---|---|
| Kumar, M.N., Begum, B.S. and R. Iniya (2022). A prospective randomized comparative study on erector spinae plane block and serratus anterior plane block in the postoperative pain management after breast surgeries. International Journal of Health Sciences | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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Sampling method will be simple random. Patients will be randomly assigned into one of the following groups using opaque sealed envelopes:
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|
| Unilateral Serratus Anterior group | Procedure | 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. |
|
|
If VAS >3 units on a scale postoperatively, IV increment of pethidine 30 mg diluted in 5 ml saline will be given.
| at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively |
| Rate of vital data changes over the postoperative period | 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. | every 2 hour during the first 6 hours and then every 6 hours for 24 hours postoperatively. |
| Incidence of pneumothorax |
| Intra-operatively |
| Gola, W., Białka, S., Andrzejewska, A., Palaczynski, P. and Misiołek, H. (2022). Fascial plane blocks for breast surgery - current state of knowledge. Anaesthesiology Intensive Therapy, \[online\] 54(3), pp.262-270. | View source |
| Mangold, M.S., Rüber, F., Steinack, C., Gautschi, F., Wani, J., Grimaldi, S. and Franzen, D.P. (2023). Lung Ultrasound for the Exclusion of Pneumothorax after Interventional Bronchoscopies-A Retrospective Study. Journal of Clinical Medicine, \[online\] 12( | View source |
| Muhammad, Q.U.A., Sohail, M.A., Azam, N.M., Bashir, H.H., Islam, H., Ijaz, R., Aquil, S., Mansoor, T., Dhakal, B., Fatima, T., Noor, J., Khan, A.S., Iqbal, A., Khatri, M. and Kumar, S. (2024). Analgesic efficacy and safety of erector spinae versus serrat | View source |
| Nair, A., \&Diwan, S. (2022). Efficacy of ultrasound-guided serratus anterior plane block for managing pain due to multiple rib fractures: a scoping review. Cureus, 14(1). | View source |
| Ülgey, A., Pehlivan, S. S., \&Demir, Ö. F. (2021). Postoperative thoracic pain treatment: serratus anterior or erector spinae plane block?. The Thoracic and Cardiovascular Surgeon, 69(06), 570-576. | View source |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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