- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07647367
Subtransverse Interligamentary Block Versus Paravertebral Block for Quality of Recovery After Mastectomy
2 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
60
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Mai Salah Salem, MD anesthesia, SIC
- Número de telefone: 002 01061107658
- E-mail: mai.salah@med.tanta.edu.eg
Locais de estudo
-
-
-
Tanta, Egito, 31527
- Recrutamento
- Tanta University Hospital
-
-
Gharbia Governorate
-
Tanta, Gharbia Governorate, Egito, 31527
- Recrutamento
- Tanta University Hospital
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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
Outros nomes:
|
|
Comparador Ativo: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Postoperative quality of recovery
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Postoperative pain score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
|
The degree of patient satisfaction
Prazo: 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
|
|
Block performance time
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
20 de junho de 2026
Conclusão Primária (Estimado)
1 de dezembro de 2026
Conclusão do estudo (Estimado)
1 de janeiro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
9 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de junho de 2026
Primeira postagem (Real)
15 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de agosto de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 36265PR77/5/26
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
The data will be available upon a reasonable request from the corresponding author
Prazo de Compartilhamento de IPD
The data will be available upon a reasonable request from the corresponding author after the end of the study for 1 year
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .