Costotransverse Foramen BlockNCT07367568
Costotransverse Foramen Block With Erector Spinae Plane Block in Modified Radical Mastectomy
A study testing Costotransverse foramen block and Erector spinae plane block in people with Costotransverse Foramen Block and Erector Spinae Plane Block, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
This study aims to compare the costotransverse foramen block with erector spinae plane block in modified radical mastectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Costotransverse Foramen Block, Erector Spinae Plane Block, Modified Radical Mastectomy
- What is being tested?
- Costotransverse foramen block and Erector spinae plane block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jan 2026to 1 Jun 2026
- Phase
- Interventional
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult females > 18 years and ≤ 65 years old.
- American Society of Anesthesiologists (ASA) physical status П-III.
- Body mass index (BMI) 18-35 kg/m2.
- Scheduled for modified radical mastectomy.
Who cannot join
- Known allergy or hypersensitivity to local anesthetic agents.
- Active infection at the injection site (e.g., cellulitis, abscess).
- Coagulopathy or ongoing anticoagulant/antiplatelet therapy [International Normalized Ratio (INR) > 1.5 or platelet count < 100,000/µL].
- Severe respiratory, cardiac, hepatic, or renal disease.
- Morbid obesity.
- Severe cognitive impairment or uncooperative behavior that could interfere with block placement.
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
Cairo University
Cairo, 12613
Mai M Elrawas, MD, 00201222177242, mai.elrawas@nci.cu.edu.eg
About this study
Official title: Comparison of Costotransverse Foramen Block With Erector Spinae Plane Block in Modified Radical Mastectomy: A Randomized Controlled Trial
This study aims to compare the costotransverse foramen block with erector spinae plane block in modified radical mastectomy.
Read the detailed description
Postoperative pain following modified radical mastectomy (MRM) is a considerable consequence, impacting the ipsilateral upper limbs, axillae, and thorax, resulting in diminished functional ability and substantial economic and societal repercussions.
Erector spinae plane block (ESPB), an interfascial block, minimizes nerve and vessel injury by allowing local anesthetics to diffuse across relevant spaces; it is technically simpler and has shown benefits in reducing postoperative analgesic use and pain scores.
A novel technique, the costotransverse foramen block (CTFB), is one type of Inter-transverse process (ITP) blocks. This technique entails the anterior dispersion of the local anesthetic injectate into the paravertebral region, affecting the thoracic nerve at the injection site and neighboring levels, while exhibiting negligible posterior diffusion of dye to the deep back muscles
- Being tested
- Costotransverse foramen block, Erector spinae plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Costotransverse foramen blockOther
Patients will receive an ipsilateral ultrasound-guided costotransverse foramen block with injection of 20 ml bupivacaine 0.25%.
Erector spinae plane blockOther
Patients will receive an ipsilateral ultrasound-guided erector spinae plane block with injection of 20 ml bupivacaine 0.25%.
| Study group | Role | What they receive |
|---|---|---|
| CTFB Group | Experimental | Patients will receive an ipsilateral ultrasound-guided costotransverse foramen block with injection of 20 ml bupivacaine 0.25%. Receives: Other: Costotransverse foramen block |
| ESPB Group | Experimental | Patients will receive an ipsilateral ultrasound-guided erector spinae plane block with injection of 20 ml bupivacaine 0.25%. Receives: Other: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
If the numeric rating scale (NRS) is ≥ 4, an IV morphine dose (3 mg) will be provided Paracetamol 1 gm and ketorolac 30 mg will be administered every 8 hours postoperatively.
Measured: 24 hours postoperatively
Secondary outcomes (6)
Degree of pain
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS score will be recorded in post-anesthesia care unit (PACU) then at 1, 6, 12, 18, 24, and 48 hours postoperatively.
Measured: 48 hours postoperatively
Time to first request of rescue analgesia
Time to first request of rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.
Measured: 24 hours postoperatively
Intraoperative fentanyl consumption
Intraoperative fentanyl consumption will be recorded.
Measured: Intraoperatively
Mean arterial pressure
Mean arterial pressure will be recorded immediately before induction of anesthesia, 15 min after performing the block incision and at 20-minute intervals intraoperatively, and then hourly till 4 hours postoperatively.
Measured: 4 hours postoperatively
Heart rate
Heart rate will be recorded immediately before induction of anesthesia, 15 min after performing the block incision and at 20-minute intervals intraoperatively, and then hourly till 4 hours postoperatively.
Measured: 4 hours postoperatively
Incidence of adverse effects
Incidence of adverse effects such as nausea, vomiting, hypotension, and bradycardia, pneumothorax, local anesthetic toxicity for up to 24 hours post-surgery will be documented.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start24 Jan 2026
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Costotransverse Foramen BlockStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Mohamed El Rawas, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367568
- Sponsor's protocol ID
- AP2509-501-124-203
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Costotransverse Foramen Block With Erector Spinae Plane Block in Modified Radical Mastectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07367568
- Acronym / sponsor ID
- AP2509-501-124-203
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 24 Jan 2026 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 26 Jan 2026 (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.
This study aims to compare the costotransverse foramen block with erector spinae plane block in modified radical mastectomy.
Detailed description
Postoperative pain following modified radical mastectomy (MRM) is a considerable consequence, impacting the ipsilateral upper limbs, axillae, and thorax, resulting in diminished functional ability and substantial economic and societal repercussions.
Erector spinae plane block (ESPB), an interfascial block, minimizes nerve and vessel injury by allowing local anesthetics to diffuse across relevant spaces; it is technically simpler and has shown benefits in reducing postoperative analgesic use and pain scores.
A novel technique, the costotransverse foramen block (CTFB), is one type of Inter-transverse process (ITP) blocks. This technique entails the anterior dispersion of the local anesthetic injectate into the paravertebral region, affecting the thoracic nerve at the injection site and neighboring levels, while exhibiting negligible posterior diffusion of dye to the deep back muscles
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTFB Group | Experimental | Other: Costotransverse foramen blockPatients will receive an ipsilateral ultrasound-guided costotransverse foramen block with injection of 20 ml bupivacaine 0.25%. |
| ESPB Group | Experimental | Other: Erector spinae plane blockPatients will receive an ipsilateral ultrasound-guided erector spinae plane block with injection of 20 ml bupivacaine 0.25%. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult females > 18 years and ≤ 65 years old.
- American Society of Anesthesiologists (ASA) physical status П-III.
- Body mass index (BMI) 18-35 kg/m2.
- Scheduled for modified radical mastectomy.
Key exclusion criteria (6 listed)
- Known allergy or hypersensitivity to local anesthetic agents.
- Active infection at the injection site (e.g., cellulitis, abscess).
- Coagulopathy or ongoing anticoagulant/antiplatelet therapy [International Normalized Ratio (INR) > 1.5 or platelet count < 100,000/µL].
- Severe respiratory, cardiac, hepatic, or renal disease.
- Morbid obesity.
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 |
|---|---|---|
| Costotransverse foramen blockPatients will receive an ipsilateral ultrasound-guided costotransverse foramen block with injection of 20 ml bupivacaine 0.25%. | Other | CTFB Group |
| Erector spinae plane blockPatients will receive an ipsilateral ultrasound-guided erector spinae plane block with injection of 20 ml bupivacaine 0.25%. | Other | ESPB Group |
Primary outcome
Total morphine consumption
Time frame: 24 hours postoperatively
If the numeric rating scale (NRS) is ≥ 4, an IV morphine dose (3 mg) will be provided Paracetamol 1 gm and ketorolac 30 mg will be administered every 8 hours postoperatively.
6 secondary outcomes
Degree of pain
Time frame: 48 hours postoperatively
Time to first request of rescue analgesia
Time frame: 24 hours postoperatively
Intraoperative fentanyl consumption
Time frame: Intraoperatively
Mean arterial pressure
Time frame: 4 hours postoperatively
Heart rate
Time frame: 4 hours postoperatively
Incidence of adverse effects
Time frame: 24 hours postoperatively
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 Jan 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 study testing Costotransverse foramen block and Erector spinae plane block in people with Costotransverse Foramen Block and Erector Spinae Plane Block, run by National Cancer Institute, Egypt 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 4 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 Jan 2026. 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.
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?
Contact Mai M Elrawas, MD (00201222177242, mai.elrawas@nci.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2026.