Modified Radical MastectomyPhase 3FMASUMD66/2025NCT06947330
Comparison Between Erector Spinae Plane Block Versus Serratus Anterior Plane Block Regarding Analgesia Post Modified Radical Mastectomy
A Phase 3 study testing Unilateral Erector Spinae group and Unilateral Serratus Anterior group in people with Modified Radical Mastectomy and Breast Cancer, run by Kholoud Usama at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Modified Radical Mastectomy, Breast Cancer
- What is being tested?
- Unilateral Erector Spinae group and Unilateral Serratus Anterior group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Mar 2025to 4 Mar 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA Physical Status II, or III.
- Age 21 - 65 years.
- Female gender
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Ain-Shams University
Cairo, Waili, 0000
Kholoud Usama Soliman, Master degree, +20 01285303039, kholoud.usama@med.asu.edu.eg
Amir Ibrahim Mohamed Salah, Doctorate degree, Professor
About this study
Official title: Comparison Between Ultrasound Guided Erector Spinae Plane Block Versus Ultrasound Guided Serratus Anterior Plane Block Regarding Analgesia Post Modified Radical Mastectomy
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?
Read more
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.
Read the 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.
- Conditions
- Modified Radical Mastectomy, Breast Cancer
- Being tested
- Unilateral Erector Spinae group, Unilateral Serratus Anterior group
- Keywords
- Breast Cancer, Modified Radical Mastectomy, Peripheral Nerve Block, Dexmedetomidine, Erector Spinae Plane Block, Serratus Anterior Plane Block, Ultrasound Guided, Adult Female
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral Erector Spinae groupProcedure or surgery
Also called Peripheral Nerve Block using Precedex, Erector Spinae block with Precedex as an adjuvant drug
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.
Unilateral Serratus Anterior groupProcedure or surgery
Also called Peripheral Nerve Block using dexmedetomidine, Serratus Anterior Block with dexmedetomidine 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Unilateral Erector Spinae group |
| 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. Receives: Procedure: Unilateral Serratus Anterior group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Score for pain
- 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;
Measured: at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively
Secondary outcomes (4)
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.
Measured: at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively
Duration of analgesia postoperatively in hours.
If VAS >3 units on a scale postoperatively, IV increment of pethidine 30 mg diluted in 5 ml saline will be given.
Measured: 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.
Measured: every 2 hour during the first 6 hours and then every 6 hours for 24 hours postoperatively.
Incidence of pneumothorax
- 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.
Measured: Intra-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start3 Mar 2025
- Primary completion3 Mar 2026 (estimated)
- Study completion4 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Modified Radical MastectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kholoud Usama
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kholoud Usama, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947330
- Sponsor's protocol ID
- FMASU-MD66/2025
- Acronym
- FMASUMD66/2025
- Status last verified
- Apr 2025
- First submitted
- 13 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37220544Abd 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.
PubMed 38741901
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultrasound Guided Erector Spinae Plane Block Versus Ultrasound Guided Serratus Anterior Plane Block Regarding Analgesia Post Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT06947330
- Acronym / sponsor ID
- FMASUMD66/2025 / FMASU-MD66/2025
- Conditions
- Modified Radical Mastectomy, Breast Cancer
- Keywords
- Breast Cancer, Modified Radical Mastectomy, Peripheral Nerve Block, Dexmedetomidine, Erector Spinae Plane Block, Serratus Anterior Plane Block, Ultrasound Guided, Adult Female
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kholoud UsamaUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 3 Mar 2026 (estimated)
- Study completion
- 4 Mar 2026 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Unilateral Erector Spinae group | Active comparator | Procedure: Unilateral Erector Spinae group-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 | Procedure: Unilateral Serratus Anterior group-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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA Physical Status II, or III.
- Age 21 - 65 years.
- Female gender
Key exclusion criteria (6 listed)
- ASA IV, V, VI.
- Infection at site of block.
- Coagulopathy, or patients on antiplatelets, or anticoagulants.
- Previous anesthetic allergy to bupivacaine.
- Distant organ metastasis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unilateral Erector Spinae groupAlso: Peripheral Nerve Block using Precedex, Erector Spinae block with Precedex as an adjuvant drugOn 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. | Procedure or surgery | Unilateral Erector Spinae group |
| Unilateral Serratus Anterior groupAlso: Peripheral Nerve Block using dexmedetomidine, Serratus Anterior Block with dexmedetomidine as an adjuvant drugOnce 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. | Procedure or surgery | Unilateral Serratus Anterior group |
Primary outcome
Visual Analog Score for pain
Time frame: 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;
4 secondary outcomes
Total dose of pethidine in mg.
Time frame: at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively
Duration of analgesia postoperatively in hours.
Time frame: at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively
Rate of vital data changes over the postoperative period
Time frame: every 2 hour during the first 6 hours and then every 6 hours for 24 hours postoperatively.
Incidence of pneumothorax
Time frame: Intra-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Background: PubMed 37220544Chen 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.
- Background: PubMed 38741901Abd 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.
- 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 SciencesLink provided by the sponsor.
- 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.Link provided by the sponsor.
- 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(Link provided by the sponsor.
- 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 serratLink provided by the sponsor.
- 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).Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Unilateral Erector Spinae group and Unilateral Serratus Anterior group in people with Modified Radical Mastectomy and Breast Cancer, run by Kholoud Usama at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Score for pain (time frame: at 0, 2, 4, 6, 8, 16, 20, 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06947330, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.