NCT Number: NCT06947330
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.
Interested in participating?
Request Info21 year–65 year
Female
Interventional
Phase 3
Cairo, Waili, 0000, Egypt
Location status: Recruiting
Amir Ibrahim Mohamed Salah, Doctorate degree, Professor
PRINCIPAL_INVESTIGATOR
Kholoud Usama Soliman, Master degree
CONTACT
Mohamed Ibrahim Ibrahim Sobhy, Doctorate degree, Lecturer
SUB_INVESTIGATOR
Randa Ali Shoukry Mohamed, Doctorate degree, Professor
SUB_INVESTIGATOR
Sanaa Mohamed Mohamed Elfawal, Doctorate degree, Professor
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Peripheral Nerve Block using Precedex, Erector Spinae block with Precedex as an adjuvant drug
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.
Other names: Peripheral Nerve Block using dexmedetomidine, Serratus Anterior Block with dexmedetomidine as an adjuvant drug
Time frame: at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Intra-operatively
Kholoud Usama
Other
Comparison Between Ultrasound Guided Erector Spinae Plane Block Versus Ultrasound Guided Serratus Anterior Plane Block Regarding Analgesia Post Modified Radical Mastectomy
Acronym: FMASUMD66/2025
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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