Chemical Rectus Sheath BlockNCT07855380
Ultrasound Guided- Chemical Rectus Sheath Block for Chronic Pain After Abdominal Midline Incision in Cancer Surgeries
A study testing Saline 0.9% and Transversalis fascia plane block in people with Chemical Rectus Sheath Block and Chronic Pain, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate peri-operative analgesia efficacy of ultrasound guided transversalis fascia plane block in cancer patients undergoing inguinal lymph node dissection Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chemical Rectus Sheath Block, Chronic Pain, Abdominal Midline Incision
- What is being tested?
- Saline 0.9% and Transversalis fascia plane block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2026to 1 Dec 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) class I and II.
- Age ≥ 18 and ≤ 65 Years.
- Cancer patients for inguinal lymph node dissection.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
Who cannot join
- Patient refusal.
- Local infection at the puncture site.
- Coagulopathies with platelet count below 50,000 or an INR>1.6.
- Unstable cardiovascular disease.
- History of psychiatric and cognitive disorders.
- Patients allergic to medication used.
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
Ahmed S Abdelgalil, MD, 00201098426689, ahmed.salah@nci.cu.edu.eg
About this study
Official title: Evaluation of Ultrasound Guided- Chemical Rectus Sheath Block for Chronic Pain After Abdominal Midline Incision in Cancer Surgeries: A Prospective Randomized Controlled Study
The aim of this study is to evaluate peri-operative analgesia efficacy of ultrasound guided transversalis fascia plane block in cancer patients undergoing inguinal lymph node dissection
Read the detailed description
Inguinal lymph node dissection is the surgical removal of lymph nodes from your groin (where your legs meet your lower abdomen). Inguinal lymph node dissection is used to see if cancer has spread from certain areas (usually your penis, vulva, anus or the skin on your legs or torso), remove lymph nodes that may be cancerous or have a high chance of becoming cancerous, reduce the risk that cancer will come back in the future and help providers understand the options for treating your cancer and help you know what to expect.
Transversalis fascia plane block (TFPB) used in patients undergoing various surgeries like iliac crest bone harvesting, appendicectomy, cecostomy and inguinal hernia repair, often in combination with TAP block.
The initial description of TFPB was with patients in the supine position, with a linear array or curvilinear probe placed between the iliac crest and the costal margin. The external oblique, internal oblique and transversus abdominis muscles and the transversus aponeurosis are identified.
- Being tested
- Saline 0.9%, Transversalis fascia plane block
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline 0.9%Drug
Patients will receive a sham block was performed using an equivalent volume of normal saline 0.9%.
Transversalis fascia plane blockDrug
Also called 20 ml of bupivacaine 0.25%
Patients will receive ultrasound guided transversalis fascia plane block.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Sham comparator | Patients will receive a sham block was performed using an equivalent volume of normal saline 0.9%. Receives: Drug: Saline 0.9% |
| Group 2 | Experimental | Patients will receive ultrasound guided transversalis fascia plane block. Receives: Drug: Transversalis fascia plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 24 hours postoperatively
Secondary outcomes (5)
Total fentanyl consumption
When elevation of Heart rate (HR) or mean arterial blood pressure (MAP) ≥ 20% of the baseline will be treated by fentanyl 0.5 μg / kg.
Measured: Intraoperatively
Total opioid consumption
The patients will be observed in the postoperative care unit for 2 h, and rescue analgesia will be provided in the form of intravenous morphine 3 mg with maximum dose of 0.1 mg/kg/dose (max 0.3 mg/kg/day) boluses if the pain score >3. The total amount of morphine given in 24 h will be recorded for every patient.
Measured: 24 hours postoperatively
Mean arterial pressure
Mean arterial pressure will be recorded before injection of the local anesthetics to be defined as a baseline reading and after injection then will be recorded immediately before and after surgical incision, at 30 min intervals intraoperatively, and immediately postoperative and at 2, 4, 6, 12 and 24 h postoperatively.
Measured: 24 hours postoperatively
Heart rate
Heart rate will be recorded before injection of the local anesthetics to be defined as a baseline reading and after injection then will be recorded immediately before and after surgical incision, at 30 min intervals intraoperatively, and immediately postoperative and at 2, 4, 6, 12 and 24 h postoperatively.
Measured: 24 hours postoperatively
Incidence of complications
Incidence of complications such as hemodynamic instability, nausea, vomiting, failed block, unintentional intravascular injection of local anesthesia and local anesthetic toxicity will be recorded
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 posted2 Oct 2026
- Study start1 May 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemical Rectus Sheath 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
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Salah Ahmed Abd Elgalil, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855380
- Sponsor's protocol ID
- 04-2026-300865
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ultrasound Guided- Chemical Rectus Sheath Block for Chronic Pain After Abdominal Midline Incision in Cancer Surgeries: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07855380
- Acronym / sponsor ID
- 04-2026-300865
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Oct 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.
The aim of this study is to evaluate peri-operative analgesia efficacy of ultrasound guided transversalis fascia plane block in cancer patients undergoing inguinal lymph node dissection
Detailed description
Inguinal lymph node dissection is the surgical removal of lymph nodes from your groin (where your legs meet your lower abdomen). Inguinal lymph node dissection is used to see if cancer has spread from certain areas (usually your penis, vulva, anus or the skin on your legs or torso), remove lymph nodes that may be cancerous or have a high chance of becoming cancerous, reduce the risk that cancer will come back in the future and help providers understand the options for treating your cancer and help you know what to expect.
Transversalis fascia plane block (TFPB) used in patients undergoing various surgeries like iliac crest bone harvesting, appendicectomy, cecostomy and inguinal hernia repair, often in combination with TAP block.
The initial description of TFPB was with patients in the supine position, with a linear array or curvilinear probe placed between the iliac crest and the costal margin. The external oblique, internal oblique and transversus abdominis muscles and the transversus aponeurosis are identified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Sham comparator | Drug: Saline 0.9%Patients will receive a sham block was performed using an equivalent volume of normal saline 0.9%. |
| Group 2 | Experimental | Drug: Transversalis fascia plane blockPatients will receive ultrasound guided transversalis fascia plane block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) class I and II.
- Age ≥ 18 and ≤ 65 Years.
- Cancer patients for inguinal lymph node dissection.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
Key exclusion criteria (6 listed)
- Patient refusal.
- Local infection at the puncture site.
- Coagulopathies with platelet count below 50,000 or an INR>1.6.
- Unstable cardiovascular disease.
- History of psychiatric and cognitive disorders.
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 |
|---|---|---|
| Saline 0.9%Patients will receive a sham block was performed using an equivalent volume of normal saline 0.9%. | Drug | Group 1 |
| Transversalis fascia plane blockAlso: 20 ml of bupivacaine 0.25%Patients will receive ultrasound guided transversalis fascia plane block. | Drug | Group 2 |
Primary outcome
Degree of pain
Time frame: 24 hours postoperatively
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").
5 secondary outcomes
Total fentanyl consumption
Time frame: Intraoperatively
Total opioid consumption
Time frame: 24 hours postoperatively
Mean arterial pressure
Time frame: 24 hours postoperatively
Heart rate
Time frame: 24 hours postoperatively
Incidence of complications
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 2 Oct 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.
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 Saline 0.9% and Transversalis fascia plane block in people with Chemical Rectus Sheath Block and Chronic Pain, 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 2 Oct 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. Some participants in this study may receive a placebo. 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 Ahmed S Abdelgalil, MD (00201098426689, ahmed.salah@nci.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pain (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 2 Oct 2026.