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Quadroiliac Plane Block for Analgesia After Renal Transplantation

29 de julho de 2026 atualizado por: Engin Ihsan Turan, Kanuni Sultan Suleyman Training and Research Hospital

Analgesic Efficacy of Ultrasound-Guided Quadroiliac Plane Block Versus Surgical Wound Infiltration in Patients Undergoing Renal Transplantation: A Prospective, Randomized, Double-Blind, Controlled Clinical Trial

Renal transplantation is a major abdominal surgical procedure that may cause moderate to severe postoperative pain. Opioids are commonly used as part of multimodal analgesia; however, opioid-related adverse effects such as sedation, respiratory depression, nausea, vomiting, and constipation may delay recovery and mobilization.

The quadroiliac plane block is an ultrasound-guided interfascial plane block performed near the attachment of the quadratus lumborum muscle to the iliac crest. The technique may provide analgesia over a broad lower abdominal area and may reduce postoperative opioid requirements.

This prospective, randomized, double-blind, controlled clinical trial will compare an ultrasound-guided unilateral quadroiliac plane block with surgical wound infiltration in adult patients undergoing renal transplantation. Participants will be randomly assigned to receive either a quadroiliac plane block with 40 mL of 0.25% bupivacaine or surgical wound infiltration with 10 mL of 0.25% bupivacaine.

All participants will receive standardized multimodal analgesia and intravenous patient-controlled analgesia with tramadol. The primary objective is to compare cumulative tramadol consumption during the first 24 hours after surgery. Postoperative pain scores, dermatomal sensory distribution, motor block, nausea, vomiting, sedation, and quality of recovery will also be evaluated.

Visão geral do estudo

Descrição detalhada

This study is designed as a prospective, randomized, double-blind, parallel-group, controlled clinical trial involving adult patients undergoing renal transplantation.

Eligible participants will be randomly assigned in a 1:1 ratio to either the quadroiliac plane block group or the surgical wound infiltration group. A computer-generated block-randomization sequence will be used. Treatment assignments will be concealed in sequentially prepared, sealed envelopes and managed by a study team member who is not involved in postoperative outcome assessment.

Participants and postoperative outcome assessors will be masked to group allocation. The anesthesiologist performing the assigned intervention will be aware of the allocation but will not participate in postoperative data collection. The intervention will be performed while the participant remains anesthetized.

Quadroiliac Plane Block Group Participants assigned to the experimental group will receive an ultrasound-guided unilateral quadroiliac plane block on the surgical side. The participant will be placed in the lateral decubitus position. A low-frequency curvilinear ultrasound transducer will be positioned immediately above the posterior superior iliac spine and oriented parallel to the vertebral column.

The quadratus lumborum muscle, its attachment to the iliac crest, and the erector spinae muscle will be identified. A 22-gauge, 80-mm echogenic block needle will be advanced using an in-plane approach toward the fascial plane between the quadratus lumborum and erector spinae muscles. After confirmation of the target plane by hydrodissection and negative aspiration, 40 mL of 0.25% bupivacaine will be administered.

Surgical Wound Infiltration Group Participants assigned to the active-comparator group will receive surgical wound infiltration after completion of surgical closure. A total of 10 mL of 0.25% bupivacaine will be administered along the surgical incision into the subcutaneous tissues using an evenly distributed infiltration technique.

Standardized Postoperative Analgesia

At the end of surgery, all participants will receive the following intravenous medications:

Tramadol 100 mg Paracetamol 1 g Dexketoprofen 50 mg Postoperatively, intravenous paracetamol 1 g will be administered three times daily.

Intravenous patient-controlled analgesia will be provided using tramadol at a concentration of 3 mg/mL. The device will be programmed to deliver a 20 mg patient-initiated bolus with a 15-minute lockout interval and without a background infusion.

Outcome Assessments Postoperative pain intensity will be evaluated using an 11-point Numerical Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be assessed both at rest and during movement at postoperative hours 0, 1, 6, 12, and 24.

The primary outcome will be cumulative tramadol consumption recorded by the patient-controlled analgesia device during the first 24 postoperative hours.

The sensory distribution of the quadroiliac plane block will be assessed at postoperative hour 2 using a cold sensation test with an ice cube. Relevant abdominal dermatomes will be evaluated, and areas with reduced or absent cold sensation will be recorded.

Postoperative motor function will be evaluated at predefined assessment times. The presence of nausea, vomiting, and sedation will also be recorded during the first 24 postoperative hours.

Quality of postoperative recovery will be evaluated using the Quality of Recovery-11 questionnaire at postoperative hour 24.

The study aims to determine whether the ultrasound-guided quadroiliac plane block reduces postoperative tramadol consumption and improves analgesia and recovery compared with surgical wound infiltration in patients undergoing renal transplantation.

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: Engin ihsan Turan, principal investigator
  • Número de telefone: +905382431114
  • E-mail: enginihsan@hotmail.com

Locais de estudo

    • Istanbul
      • Istanbul, Istanbul, Turquia (Türkiye), 34303
        • Recrutamento
        • Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
        • Contato:

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:

  • Age between 18 and 80 years
  • American Society of Anesthesiologists physical status I-III
  • Scheduled to undergo renal transplantation surgery
  • Ability to understand the study procedures and postoperative assessments
  • Provision of written informed consent

Exclusion Criteria:

  • Known allergy to bupivacaine or other amide-type local anesthetics
  • Infection at the planned injection site
  • Coagulopathy or anticoagulant therapy associated with an unacceptable bleeding risk for regional anesthesia
  • Sepsis
  • Severe spinal deformity or anatomical abnormality preventing performance of the quadroiliac plane block
  • Inability to cooperate or communicate reliably
  • Cognitive impairment or intellectual disability preventing informed consent or reliable outcome assessment
  • Altered level of consciousness
  • Breastfeeding
  • Refusal to participate

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: Quadro-Iliac Plane Block Group
Participants assigned to this group will receive an ultrasound-guided unilateral quadroiliac plane block on the surgical side while under general anesthesia. The block will be performed using 40 mL of 0.25% bupivacaine. All participants will receive the same standardized multimodal analgesic regimen and postoperative intravenous patient-controlled analgesia with tramadol.
With the participant in the lateral decubitus position, a low-frequency curvilinear ultrasound transducer will be positioned immediately above the posterior superior iliac spine and oriented parallel to the vertebral column. The quadratus lumborum muscle, its attachment to the iliac crest, and the erector spinae muscle will be identified. A 22-gauge, 80-mm echogenic needle will be advanced using an in-plane approach into the fascial plane between the quadratus lumborum and erector spinae muscles. After confirmation of the target plane by hydrodissection and negative aspiration, 40 mL of 0.25% bupivacaine will be administered on the surgical side.
Comparador Ativo: Surgical Wound Infiltration Group
Participants assigned to this group will receive surgical wound infiltration at the end of surgery. A total of 10 mL of 0.25% bupivacaine will be infiltrated into the subcutaneous tissues along the surgical incision. All participants will receive the same standardized multimodal analgesic regimen and postoperative intravenous patient-controlled analgesia with tramadol.
Following completion of surgical closure, a total of 10 mL of 0.25% bupivacaine will be infiltrated evenly into the subcutaneous tissues along the surgical incision. The infiltration will be performed using a standardized technique before the participant emerges from general anesthesia.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Cumulative Tramadol Consumption During the First 24 Postoperative Hours
Prazo: During the first 24 postoperative hours
The total amount of tramadol delivered by the patient-controlled analgesia device will be recorded in milligrams.
During the first 24 postoperative hours

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Postoperative Pain Scores at Rest
Prazo: At postoperative hours 0, 1, 6, 12, and 24
Pain at rest will be assessed using an 11-point Numerical Rating Scale ranging from 0, no pain, to 10, the worst imaginable pain.
At postoperative hours 0, 1, 6, 12, and 24
Postoperative Pain Scores During Movement
Prazo: At postoperative hours 0, 1, 6, 12, and 24
Pain during movement will be assessed using an 11-point Numerical Rating Scale ranging from 0, no pain, to 10, the worst imaginable pain.
At postoperative hours 0, 1, 6, 12, and 24
Incidence of Postoperative Nausea and Vomiting
Prazo: During the first 24 postoperative hours
The number and proportion of participants experiencing nausea, vomiting, or both will be recorded.
During the first 24 postoperative hours
Quality of Recovery-11 Score
Prazo: At postoperative hour 24
Postoperative recovery and patient satisfaction will be assessed using the Quality of Recovery-11 questionnaire. Higher scores indicate better postoperative recovery.
At postoperative hour 24
Dermatomal Distribution Assessed by Cold Sensation
Prazo: At postoperative hour 2
The abdominal dermatomes showing changed or absent cold sensation will be assessed using an ice-cube test.
At postoperative hour 2

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

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 (Estimado)

20 de julho de 2026

Conclusão Primária (Estimado)

20 de julho de 2027

Conclusão do estudo (Estimado)

21 de julho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

16 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de julho de 2026

Primeira postagem (Real)

21 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Descrição do plano IPD

A final decision regarding the sharing of de-identified individual participant data has not yet been made. The decision will be made after completion of the study and publication of the primary results, taking into consideration participant confidentiality, ethics committee requirements, institutional policies, and applicable data protection regulations.

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 .

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