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O estudo clínico NCT07502248 para Dor pós-operatória, Total Hip Arthroplasty (THA) está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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PENG Block With or Without PPD Block for Postoperative Analgesia After Total Hip Arthroplasty 40 Randomizado
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07502248 é um estudo intervencionista para Dor pós-operatória, Total Hip Arthroplasty (THA). Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 5 de abril de 2026, com o objetivo de incluir 40 participantes. Coordenado por Kirsehir Ahi Evran Universitesi e deve ser concluído em 5 de junho de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 30 de março de 2026.
Resumo
This single-center, prospective, randomized controlled clinical trial aims to compare the postoperative analgesic efficacy of PENG block with or without posterior pericapsular deep gluteal block in adult patients undergoing elective primary total hip arthroplasty under spinal anesthesia. Total hip arthroplasty is commonly associated with moderate to severe postoperative pain. Although PENG block provides analgesia fo...Mostrar mais
Descrição detalhada
This study is planned as a single-center, prospective, randomized, controlled, double-blind trial in adult patients undergoing elective primary total hip arthroplasty under spinal anesthesia. Eligible participants will be patients aged 18 years or older, classified as ASA physical status I-III, and able to provide informed consent. Patients with ASA IV-V, serious cardiac, respiratory, hepatic, or renal disease, neuro...Mostrar mais
Título oficial
Comparison of the Efficacy of Pericapsular Nerve Group (PENG) Block Versus PENG Block Added to Posterior Pericapsular Deep Gluteal (PPD) Block for Postoperative Analgesia in Total Hip Arthroplasty
Condições médicas
Dor pós-operatóriaTotal Hip Arthroplasty (THA)Outros IDs do estudo
- KAEAH-THA-PENG-PPD-01
Número NCT
Data de início (real)
2026-04-05
Última atualização postada
2026-03-30
Data de conclusão (estimada)
2027-06-05
Inscrição (estimada)
40
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ainda não recrutando
Palavras-chave
PENG block
PPD block
Postoperative analgesia
Numeric Rating Scale
PPD block
Postoperative analgesia
Numeric Rating Scale
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Duplo-cego
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
Comparador ativoPENG Block Participants in this arm will receive ultrasound-guided PENG block after spinal anesthesia for postoperative analgesia during primary total hip arthroplasty. In addition, lateral femoral cutaneous nerve block will be performed. | Bloqueio PENG Ultrasound-guided pericapsular nerve group block performed after spinal anesthesia for postoperative analgesia in patients undergoing primary total hip arthroplasty. In Group 1, PENG block will be performed in the supine position using an in-plane technique, and 20 mL of 0.25% bupivacaine will be injected between the psoas tendon and iliopubic ramus. In both groups, lateral femoral cutaneous nerve block will also be ...Mostrar mais |
Comparador ativoPENG Plus PPD Block Participants in this arm will receive ultrasound-guided PENG block followed by ultrasound-guided posterior pericapsular deep gluteal block after spinal anesthesia for postoperative analgesia during primary total hip arthroplasty. In addition, lateral femoral cutaneous nerve block will be performed. | Bloqueio PENG Ultrasound-guided pericapsular nerve group block performed after spinal anesthesia for postoperative analgesia in patients undergoing primary total hip arthroplasty. In Group 1, PENG block will be performed in the supine position using an in-plane technique, and 20 mL of 0.25% bupivacaine will be injected between the psoas tendon and iliopubic ramus. In both groups, lateral femoral cutaneous nerve block will also be ...Mostrar mais Deep posterior gluteal compartment block Ultrasound-guided posterior pericapsular deep gluteal block performed after PENG block and spinal anesthesia for postoperative analgesia in patients undergoing primary total hip arthroplasty. In Group 2, the block will be performed in the lateral decubitus position with the hip and knee flexed to 90 degrees, and 30 mL of 0.25% bupivacaine will be injected after needle placement to the posterior acetabular rim near th...Mostrar mais |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Postoperative pain intensity at 6 hours measured by Numeric Rating Scale (NRS) | Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. The primary comparison between groups will be the NRS score at postoperative 6 hours | 6 hours after surgery |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Postoperative pain intensity over the first 24 hours measured by Numeric Rating Scale (NRS) | Postoperative pain intensity will also be assessed in the recovery room and at postoperative 2, 12, and 24 hours using the Numeric Rating Scale (NRS) | Recovery room, 2 hours, 12 hours, and 24 hours after surgery |
Total analgesic consumption during the first 24 hours | Total amount of analgesic medication consumed within the first 24 hours after surgery will be recorded and compared between groups | 24 hours after surgery |
Time to first rescue analgesic requirement | Time from block performance to first additional analgesic requirement will be recorded | Up to 24 hours after surgery |
Time to first mobilization | Time to first standing or mobilization after surgery will be recorded and compared between groups | Up to 24 hours after surgery |
Ankle dorsiflexion motor strength | Ankle dorsiflexion motor strength will be assessed postoperatively to evaluate possible motor weakness related to block spread. | Recovery room, 2 hours, 6 hours, 12 hours, and 24 hours after surgery |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
- Adults aged 18 years and older
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective primary total hip arthroplasty under spinal anesthesia
- Able to provide written informed consent
- ASA physical status IV or V
- Serious concomitant cardiac, respiratory, hepatic, or renal disease
- Known neuropsychiatric disorder
- Cognitive impairment preventing understanding or response to the Numeric Rating Scale (NRS)
- Coagulopathy
- Local anesthetic allergy
- Infection or scar at the block site
- Failed block
- Refusal to participate
- Signs of local anesthetic systemic toxicity after block
- Patients in the PENG plus PPD group who would be exposed to a total local anesthetic dose above 3 mg/kg in patients weighing less than 50 kg
- Revision total hip arthroplasty
- Total hip arthroplasty planned for fracture
Kirsehir Ahi Evran UniversitesiResponsável pelo estudo
Guzin Ceran, Investigador principal, Assistant Professor, Department of Anesthesiology and Reanimation, Kirsehir Ahi Evran Universitesi
Contato central do estudo
Contato: Guzin Ceran Assistant Professor, MD, +90-506-163-0936, [email protected]
Contato: Abdulkadir Apaydin, MD, +90-531-951-2333, [email protected]
Sem dados de locais.