An interventional study of Retro Superior Costotransverse Ligament Space Block and Rhomboid Intercostal Block in Breast Cancer, Modified Radical Mastectomy and Postoperative Pain, sponsored by Mansoura University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Mansoura University · Not applicable, Interventional, and Supportive care
Modified radical mastectomy causes significant acute postoperative pain. The rhomboid intercostal block (RIB) is an established posterior chest wall block for breast surgery. The retro superior costotransverse ligament space (retro-SCTLS) block is a newer paraspinal block that may spread toward the paravertebral space, giving broader dermatomal coverage of the breast and axilla. This randomized trial will compare the two blocks in 88 adult women having elective unilateral modified radical mastectomy at Mansoura University Oncology Center. Each block uses 20 mL of 0.25% bupivacaine, given before general anesthesia under light dexmedetomidine sedation. The primary outcome is total intravenous morphine consumption in the first 24 hours after surgery. Secondary outcomes include pain scores, time to first rescue analgesia, intraoperative fentanyl use, sensory block extent, nausea and vomiting, block-related adverse events, quality of recovery (QoR-15), patient satisfaction and persistent pain at 3 months.
Patients will be randomized 1:1 to retro-SCTLS block at T3-T4 or RIB at T5-T6, using a computer-generated sequence with variable block sizes and sequentially numbered opaque sealed envelopes. To maintain blinding, both regions will be scanned in all patients and identical dressings applied at both sites. Sensory block (cold testing, T1-T6 and axilla) will be assessed 30 minutes after injection by a blinded assessor. General anesthesia and postoperative multimodal analgesia are standardized: paracetamol 1 g IV every 6 h and ketorolac 30 mg IV every 12 h, with rescue morphine 2 mg IV for NRS ≥ 4. The primary analysis is intention-to-treat using the Mann-Whitney U test, with the Hodges-Lehmann median difference and 95% CI. Assuming a 2 mg difference and a conservative SD of 3.1 mg (two-sided α 0.05, 80% power), 39 patients per group are required; 44 per group (88 total) will be enrolled to allow for 10% dropout.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 88 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ultrasound-guided retro superior costotransverse ligament space block at T3-T4 with 20 mL of 0.25% bupivacaine, before induction under dexmedetomidine sedation.
Procedure: Retro Superior Costotransverse Ligament Space Block
Ultrasound-guided RIB at T5-T6 with 20 mL of 0.25% bupivacaine, before induction under dexmedetomidine sedation.
Procedure: Rhomboid Intercostal Block
Single-injection block at T3-T4 under ultrasound guidance, with 20 mL of 0.25% bupivacaine injected into the space posterior to the superior costotransverse ligament. It is performed before general anesthesia under standardized dexmedetomidine sedation (0.5 mcg/kg load, then 0.3 mcg/kg/h).
Also known as: retro-SCTLS block; RSCTL block; intertransverse process block
Single-injection block at T5-T6 under ultrasound guidance, with 20 mL of 0.25% bupivacaine injected into the fascial plane between the rhomboid major and intercostal muscles, medial to the scapula. It is performed before general anesthesia under the same standardized dexmedetomidine sedation (0.5 mcg/kg load, then 0.3 mcg/kg/h).
Cumulative 24-hour intravenous morphine consumption
Total rescue IV morphine (mg) given in the first 24 hours after surgery. Rescue morphine 2 mg IV is given when NRS at rest is ≥ 4 or on patient request, repeated every 10 minutes until NRS is \< 4.
Time frame: From arrival in the post-anesthesia care unit (PACU) to 24 hours postoperatively
Postoperative pain scores at rest and on movement
Pain intensity on the Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain), at rest and during ipsilateral shoulder abduction to 90°. If abduction isn't tolerated, three deep breaths are used instead.
Time frame: 1, 2, 4, 6, 12 and 24 hours after PACU arrival
Time to first rescue analgesia
Time (minutes) from PACU arrival to the first rescue morphine dose. Patients who need no rescue are censored at 24 hours.
Time frame: From PACU arrival to the first rescue morphine dose, assessed up to 24 hours postoperatively
Total intraoperative fentanyl consumption
Total fentanyl (mcg) given during surgery, including the induction dose and rescue doses (0.5 mcg/kg). Rescue is triggered when MAP or HR rises \> 20% above the pre-incision baseline for ≥ 2 minutes.
Time frame: During surgery: from induction of anesthesia to end of surgery (approximately 2-3 hours)
Extent of sensory block
Number of dermatomes (T1-T6 and axilla) with reduced or absent cold sensation (ethyl chloride) on the operative side compared with the contralateral side. Block success is defined as ≥ 3 contiguous dermatomes.
Time frame: 30 minutes after block injection
Incidence of postoperative nausea and vomiting (PONV)
Number of patients with any episode of nausea, retching or vomiting.
Time frame: Assessed at 1, 2, 4, 6, 12, and 24 hours after PACU arrival (cumulative incidence up to 24 hours)
Rescue antiemetic requirement
Number of patients needing rescue metoclopramide 10 mg IV.
Time frame: Assessed at 1, 2, 4, 6, 12, and 24 hours after PACU arrival (cumulative requirement up to 24 hours)
Block performance time
Time (seconds) from first placement of the ultrasound probe on the skin to needle withdrawal.
Time frame: Periprocedural: during block performance, before induction of anesthesia
Number of needle passes
Number of needle redirections needed to reach the target plane (maximum 3).
Time frame: Periprocedural: during block performance, before induction of anesthesia
Incidence of block-related adverse events
Number of patients with any of the following: hypotension (MAP \< 65 mmHg or \> 20% decrease from baseline) bradycardia (HR \< 50 bpm) vascular puncture, hematoma or puncture-site infection pneumothorax (confirmed by lung ultrasound or chest X-ray) contralateral sensory block suggesting epidural spread local anesthetic systemic toxicity
Time frame: From block performance up to 24 hours postoperatively
Sedation score
Ramsay Sedation Scale (1 = anxious/agitated to 6 = no response).
Time frame: 1, 2, 4, 6, 12 and 24 hours after PACU arrival
Quality of recovery (QoR-15)
Quality of Recovery-15 questionnaire score (range 0-150; higher scores mean better recovery).
Time frame: Baseline (preoperatively, on the day of surgery) and 24 hours postoperatively
Patient satisfaction with postoperative analgesia
5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).
Time frame: 24 hours postoperatively
Persistent postsurgical pain
Incidence of pain at or near the surgical site present on ≥ 4 of the 7 days before assessment, by structured telephone interview. Intensity is rated on the NRS (0-10), and neuropathic features are screened with the DN4 interview questionnaire (DN4i, score 0-7; ≥ 3 suggests neuropathic pain).
Time frame: 3 months postoperatively
Plan to share: Yes — De-identified individual participant data underlying the results reported in the published article (text, tables, figures, and appendices) will be shared, including the primary outcome (24-hour morphine consumption), pain scores, and secondary outcome data.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 3 months and ending 5 years after publication of the primary article.
Access criteria: Data will be available to researchers who provide a methodologically sound proposal, on reasonable request to the principal investigator (m_atolba1234@mans.edu.eg). Requestors will be required to sign a data access agreement, and approval from the Mansoura Faculty of Medicine IRB may be required.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Apr 2027, 5 months later.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 5 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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