- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07647367
Subtransverse Interligamentary Block Versus Paravertebral Block for Quality of Recovery After Mastectomy
2 augusti 2026 uppdaterad av: Mai Salah Salem, Tanta University
Ultrasound-Guided Subtransverse Interligamentary Plane Block Versus Thoracic Paravertebral Block for Quality of Recovery After Modified Radical Mastectomy: A Randomized Non-Inferiority Trial
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.
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Mai Salah Salem, MD anesthesia, SIC
- Telefonnummer: 002 01061107658
- E-post: mai.salah@med.tanta.edu.eg
Studieorter
-
-
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Tanta, Egypten, 31527
- Rekrytering
- Tanta University Hospital
-
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Gharbia Governorate
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Tanta, Gharbia Governorate, Egypten, 31527
- Rekrytering
- Tanta University Hospital
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Adult female patients aged 18 to 65 years with American Society of Anesthesiologists (ASA) Physical Status I - III, who were scheduled for unilateral MRM surgery under general anesthesia and able to understand and complete the QoR-15 questionnaire
Exclusion Criteria:
• Patients declined to participate in the trial.
- History of allergy to the used local anesthetic (LA) drugs.
- Patients with cutaneous lesions at the needle entry point.
- Coagulopathy or current anticoagulant therapy contraindicating regional block.
- Patients with severe hepatic, renal, cardiac, or respiratory disease.
- Psychiatric or cognitive disorder interfering with QoR-15 assessment
- Chronic opioid use or chronic pain syndrome.
- Failed block.
- Morbid obesity (body mass index >40 kg/m2)
- Intraoperative major complications requiring postoperative ICU admission.
- Pregnancy
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: subtransverse interligamentary plane block
Patients will receive ultrasound-guided subtransverse interligamentary plane block with local anesthetic mixture (20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml))
|
Patients will receieve u;trasound guided subtransverse interligamentary plane block
Andra namn:
|
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Aktiv komparator: Thoracic paravertebral block
Patients will receive ultrasound- guided thoracic paravertebral block with local anesthetic mixture (20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml))
|
Patients will receieve ultrasound guided thoracic paravertebral block
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative quality of recovery
Tidsram: It will be measured 24 hours after surgery
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative pain score
Tidsram: It will be measured at rest and during arm movement at 0,2,6,12,24 hours postoperatively
|
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
|
|
Time to first rescue analgesia
Tidsram: Postoperatively the time interval from the end of surgery until need of rescue analgesia will be recorded
|
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
Tidsram: Total needed postoperative opioid dosing during the first 24 hours will recorded
|
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
Tidsram: 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
|
Postoperative incidence of postoperative nausea and vomiting will be recorded during the first 24 hours
|
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The degree of patient satisfaction
Tidsram: it will be recorded postoperatively and 24 hours after surgery
|
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
|
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Block performance time
Tidsram: Block performance time from the start of space visualization by ultrasound until the end of local anesthetic injection
|
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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
20 juni 2026
Primärt slutförande (Beräknad)
1 december 2026
Avslutad studie (Beräknad)
1 januari 2027
Studieregistreringsdatum
Först inskickad
9 juni 2026
Först inskickad som uppfyllde QC-kriterierna
9 juni 2026
Första postat (Faktisk)
15 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 augusti 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 36265PR77/5/26
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
The data will be available upon a reasonable request from the corresponding author
Tidsram för IPD-delning
The data will be available upon a reasonable request from the corresponding author after the end of the study for 1 year
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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