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This prospective randomized controlled double blinded non-inferiority study will be carried out in Tanta University Hospitals for duration of 6 months from June 2026 to December 2026 on 60 female patients scheduled for unilatral modified radical mastectomy under general anesthesia.
Breast carcinoma is a common malignancy in females, with modified radical mastectomy (MRM) being the most frequently performed surgery. Surgical intervention is accompanied by significant challenges such as postoperative pain and stress, potentially leading to prolonged hospitalizations and complications. Previous studies had demonstrated that thoracic paravertebral block (TPVB) was effective in diminishing opioid requirements for patients undergoing breast surgery. TPVB is technically challenging, requiring skilled healthcare professionals and the narrow paravertebral space, located between the superior costotransverse ligament (SCTL) and the parietal pleura, poses a risk of inadvertent pleural puncture and vascular damage, and increased the potential for pneumothorax and haematoma. The Subtransverse process Interligamentary (STIL) plane block is a recently introduced technique that holds promise as an alternative to TPVB. STIL plane block specifically targets the region adjacent to the paravertebral space, rather than directly penetrating it, which theoretically diminishes the potential risks of inadvertent pneumothorax and hematoma compared with TPVB. Additionally, due to its close anatomical proximity to the paravertebral space, the STIL plane block may facilitate a more straightforward dispersion of local anaesthetics into this area. Research has also confirmed that the block achieved with STIL plane block is effective in providing adequate pain relief for breast surgeries. Also it was associated with decreased postoperative opioid consumption compared to the ESP block in patients undergoing MRM. With the improvement of anaesthesia technology, the quality of patient recovery is no longer solely measured by the success of the surgery or the discharge rate, but is increasingly oriented towards a "patient-centered" approach that focuses on the safety, comfort, and overall quality of recovery throughout the perioperative period. In light of the growing emphasis on improving postoperative quality of recovery while ensuring patient safety, we hypothesize that the STIL plane block will demonstrate non-inferiority to the thoracic PVB in terms of postoperative quality of recovery and analgesia in patients undergoing MRM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| subtransverse interligamentary plane block | Experimental | Patients will receive ultrasound-guided subtransverse interligamentary plane block with local anesthetic mixture (20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml)) |
|
| Thoracic paravertebral block | Active Comparator | Patients will receive ultrasound- guided thoracic paravertebral block with local anesthetic mixture (20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml)) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subtransverse interligamentary plane block (STIL) | Procedure | Patients will receieve u;trasound guided subtransverse interligamentary plane block |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative quality of recovery | Postoperative quality of recovery assessed using the Quality of Recovery-15 questionnaire which provides a global score of recovery after anesthesia and surgery by evaluating pain, comfort, emotions, independence, and support. The total score ranges from 0 to 150. Higher score = better recovery. | It will be measured 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain score | Postoperative pain score using numerical rating scale (NRS) score The NRS is an 11-point pain scale ranging from 0 to 10, where 0 means no pain and 10 means the worst imaginable pain. Participants are asked to rate their pain intensity by choosing the number that best represents their pain level. | It will be measured at rest and during arm movement at 0,2,6,12,24 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
• Patients declined to participate in the trial.
Only participants who self identity as women are eligible to participate
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mai Salah Salem, MD anesthesia, SIC | Contact | 01061107658 | 002 | mai.salah@med.tanta.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta university hospital | Tanta | 31527 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Arun N, Singh R, Kumar M. Direct Pectoral Nerve Block versus Ultrasound-Guided Paravertebral Block for Analgesia and Improved Recovery after Modified Radical Mastectomy: A Randomized Clinical Trial. Sri Lankan Journal of Anaesthesiology. 2026;34(1). | ||
| 31744747 | Result | Ince I, Dostbil A, Ozmen O, Aksoy M, Karadeniz E. Subtransverse process interligamentary (STIL) plane block for postoperative pain management after breast surgery. J Clin Anesth. 2020 May;61:109649. doi: 10.1016/j.jclinane.2019.109649. Epub 2019 Nov 17. No abstract available. | |
| 31476624 |
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The data will be available upon a reasonable request from the corresponding author
The data will be available upon a reasonable request from the corresponding author after the end of the study for 1 year
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|
| Thoracic paravertebral block (TPVB) | Procedure | Patients will receieve ultrasound guided thoracic paravertebral block |
|
| Time to first rescue analgesia | Time interval from the end of surgery until need of rescue analgesia | Postoperatively the time interval from the end of surgery until need of rescue analgesia will be recorded |
| Total postoperative opioid consumption in the first 24 hours | Total postoperative opioid consumption in the first 24 hours will be recorded | Total needed postoperative opioid dosing during the first 24 hours will recorded |
| Incidence of postoperative nausea and vomiting | Postoperative incidence of postoperative nausea and vomiting will be recorded during the first 24 hours | Postoperative incidence of postoperative nausea and vomiting will be recorded during the first 24 hours |
| The degree of patient satisfaction | The degree of patient satisfaction using level of satisfaction regarding the analgesia regimen using a 5 point Likert scale, where 1 indicates "extremely dissatisfied", 2 "unsatisfied", 3 "unsure", 4 "satisfied", and 5 "extremely satisfied" | it will be recorded postoperatively and 24 hours after surgery |
| Block performance time | Block performance time from the start of space visualization by ultrasound until the end of local anesthetic injection will be recorded | Block performance time from the start of space visualization by ultrasound until the end of local anesthetic injection |
| Result |
| Kilicaslan A, Sarkilar G, Altinok T, Tulgar S. A novel ultrasound-guided technique in peri-paravertebral area: Subtransverse process interligamentary (STIL) plane block: The game has not ended yet. J Clin Anesth. 2020 Mar;60:76-77. doi: 10.1016/j.jclinane.2019.08.047. Epub 2019 Aug 30. No abstract available. |
| 32172551 | Result | Ardon AE, Lee J, Franco CD, Riutort KT, Greengrass RA. Paravertebral block: anatomy and relevant safety issues. Korean J Anesthesiol. 2020 Oct;73(5):394-400. doi: 10.4097/kja.20065. Epub 2020 Mar 16. |
| 31280100 | Result | Gurkan Y, Aksu C, Kus A, Yorukoglu UH. Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. J Clin Anesth. 2020 Feb;59:84-88. doi: 10.1016/j.jclinane.2019.06.036. Epub 2019 Jul 4. |
| 33818764 | Result | Ferlay J, Colombet M, Soerjomataram I, Parkin DM, Pineros M, Znaor A, Bray F. Cancer statistics for the year 2020: An overview. Int J Cancer. 2021 Apr 5. doi: 10.1002/ijc.33588. Online ahead of print. |