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Comparison Between Two Different Doses of Nulbuphine _bupivacaine in TAP Block in Cancer Abdominal Surgeries

11 de outubro de 2021 atualizado por: Amira Muhammed Othman, Assiut University

Nalgesic Effect of Nulbuphine-bupivacaine Combination in Ultrasound Guided Transversus Abdominis Plane Block in Patients Undergoing Major Abdominal Cancer Surgeries .

To compare the analgesic effect of two different doses of nulbuphine (10 mg and 20 mg) added to bupivacaine in bilateral subcostal single injection in ultrasound-guided TAP block for abdominal surgeries.

Visão geral do estudo

Descrição detalhada

The ultrasound-guided TAP block will be performed before the induction of general anesthesia. Upon arrival at the operating room, the patients will be place in the supine position and an 18-gauge intravenous (IV) cannula will be inserted for IV fluid and drug administration. Basic monitoring probes (electrocardiography, non-invasive blood pressure, oxygen saturation, and temperature) will be applied, and their baseline vital signs will be recorded. Lactated Ringer's solution 10mL/ kg will be infused intravenously over 10 minutes before the initiation of the TAP block.

The TAP block will be performed with the use of ultrasound, under complete aseptic technique. A broadband linear array probe will be used with an imaging depth of 4 - 6 cm. The ultrasound probe will be placed transversely to the abdomen (horizontal plane) in the midaxillary line between the costal margin and the iliac crest. Three muscle layers are clearly seen in the image. The needle (22-gauge x 80 mm SonoPlex stim cannula, Pajunk®, Geisingen, Germany) will be inserted in a sagittal plane approximately 3 - 4 cm medial to the ultrasound probe. The point of needle insertion will be closer to the probe. For optimal imaging of the needle, it will be held parallel to the long axis of the probe (in-line view). The needle tip will be directed into the plane below the internal oblique and above the transversus abdominis muscle. A small volume of local anesthetic (2 mL) was seen to open the plane between the 2 muscles and was followed by insertion of the full dose of local anesthetic. If the 2 mL dose appears to be within the muscle rather than between them, then needle adjustment will be required. The local anesthetic injected appeared hypoechoic (black compared to the muscle layers) on ultrasound image.

The TAP block will be performed with the use of ultrasound under complete aseptic technique. A broadband linear array probe will be used with an imaging depth of 4 - 6 cm using a 22-gauge × 80 mm SonoPlex stim cannula (Pajunk®, Geisingen, Germany). Twenty minutes after the TAP block, the extent of sensory blockade will be evaluated by using the pin prick test (0 = no block, 1 = hyposthesia, and 2 = anesthesia) by another blinded attending anesthetist. Any patients with a failed block will be excluded from the studied groups.

Anesthetic Technique:

The anesthetic technique will be standardized in the 3 groups. No preoperative analgesics will be given. After a successful TAP block, ?? general anesthesia will be induced intravenously (propofol 1 - 2 mg/kg, lidocaine 1.5 mg/ kg) and fentanyl 1 μg/kg. Endotracheal intubation will be facilitated by neuromuscular blockade with cisatracurium 0.3 mg/kg. Anesthesia and muscle relaxation will be maintained with isoflurane in an air/oxygen mixture and cisatracurium 0.15 mg/kg. The patients will be mechanically ventilated in parameters that maintain the end-tidal CO2 (ETCO2) between 33 and 36 mmHg. The patients' heart rate, oxygen saturation, ETCO2, and systolic and diastolic blood pressures will be measured and recorded. Hypotension will be defined as a 15% decrease in systolic blood pressure from the base line, bradycardia as a heart rate slower than 50 beats per minute, and hypoxia as an oxygen saturation less than 90%. Hypotension will be treated with intravenous boluses of ephedrine 0.1 mg/kg, repeated as required. Bradycardia will be treated with intravenous atropine 0.01 mg/kg.

At the end of surgery, muscle relaxation will be reversed by neostigmine 50 μg/kg and atropine 10 μg/ kg. The patients will be extubated and transferred to the post-anesthesia care unit (PACU), where they will be monitored for vital signs (heart rate, non-invasive blood pressure, respiratory rate, and O2 saturation) immediately postoperatively and at 2, 4, 6, 12, 18, and 24 hours postoperatively.

The severity of pain and the presence of nausea, vomiting, and respiratory depression will be assessed postoperatively at 0, 2, 4, 6, 12, 18 and 24 hours. The severity of pain will be assessed using a 10 cm VAS at rest and coughing (0 = no pain and 10 = worst imaginable pain). Repiratory function : FVC, FEV and FEV1 /FVC ratio will be recorded postoperatively and 6,12,&24 hr. Postoperatively. If a patient's VAS score was ≥ 3, morphine will be administered intravenously by a dose of 0.05 mg/kg at 15minute intervals until complete pain relief will be achieved. Morphine administration will be ceased when the VAS score at rest and coughing was < 3 on assessment or when over-sedation or respiratory depression will occur (a respiratory rate of < 10 bpm). Rescue antiemetic will be given in the form of ???metoclopramide 10 mg (Zofran 4mg) IV when patients complained of nausea or vomiting.???? (Our primary outcome measure will be total morphine consumption in the first 24 hours postoperatively; our secondary outcome measures will be the postoperative VAS scores, the time of the first request of rescue analgesia (calculated from the time of the TAP block application), spirometry lung function testing and the incidence of postoperative side effects)

Tipo de estudo

Intervencional

Inscrição (Antecipado)

30

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

Estude backup de contato

Locais de estudo

      • Assiut, Egito
        • Amira Muhammed Othman

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

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:-

  • ASA classification I-ll,
  • Aged >18 years,
  • weight 50-85 kg,
  • Patients who will undergo abdominal cancer surgery.

Exclusion Criteria:-

  • Patient's refusal,
  • patients with a history of allergies to studied drugs,
  • Patients with coagulation disorders,
  • Patients with opioid dependence,
  • Patients with morbid obesity (body mass index more than 40 kg/m2),
  • Patients with sepsis,
  • patients with psychiatric illnesses that will interfere with the perception and assessment of pain .

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: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Group I (BN10)
patients will receive an ultrasound-guided TAP block with 20 mL of 0.25% bupivacaine , 1 mL of 10 mg of nulbuphine plus 4 mL of normal saline to reach 25 mL as total volume on each side of the abdominal wall.
patients will receive an ultrasound-guided TAP block with 20 mL of 0.25% bupivacaine, 1 mL of 10 mg of nalbuphine plus 4 mL of normal saline to reach 25 mL as total volume on each side of the abdominal wall
Comparador Ativo: Group II (BN20)
patients will receive an ultrasound-guided TAP block with 20 mL of 0.25% bupivacaine ,2 mL of 20 mg of nulbuphine plus 3 mL of normal saline to reach 25 mL as total volume on each side of the abdominal wall.
patients will receive an ultrasound-guided TAP block with 20 mL of 0.25% bupivacaine, 2 mL of 20 mg of nalbuphine plus 3 mL of normal saline to reach 25 mL as total volume on each side of the abdominal wall
Comparador Ativo: Group lll(B)
patients will receive 20 mL of 0.25%bupivacaine plus 5 mL of normal saline to reach 25 mL as total volume on each side of the abdominal wall.
patients will receive 20 mL of 0.25%bupivacaine plus 5 mL of normal saline to reach 25 mL as total volume on each side of the abdominal wall

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
time of request of first analgesia
Prazo: Time Frame: 24 hours post-operatively ]
VAS (Visual Analogue Scale, 0-100 mm; where 0 = no pain, and 100 = worst imaginable pain) will be assessed, at rest, per hour for 24 hours post operatively. Moreover, VAS will also be assessed at 12 and 24 hours post-operatively while abducting the ipsilateral arm. If the patient experiences a pain of > 3, IV morphine will be given at a dose of 2.5-5 mg per dose, with a maximum dose of 10 mg, aiming for a pain score of ≤ 3. Time which will pass until the request of first analgesia shall be determined for each group and compared.
Time Frame: 24 hours post-operatively ]

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
total morphine consumption in the first 24 hours postoperatively
Prazo: Time Frame: 24 hours post-operatively ]
If a patient's VAS score was ≥ 3, morphine will be administered intravenously by a dose of 0.05 mg/kg at 15 minute intervals until complete pain relief will be achieved. Morphine administration will be ceased when the VAS score at rest and coughing was < 3 on assessment or when over-sedation or respiratory depression will occur (a respiratory rate of < 10 bpm). Rescue antiemetic will be given in the form of ondasteron 4 mg IV when patients complained of nausea or vomiting.
Time Frame: 24 hours post-operatively ]

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Diretor de estudo: Rania M. Abdel -Emam, South Egypt cancer Institute, Assuit university hospitals
  • Diretor de estudo: Shreen M. Muhammed, A.professor, South Egypt cancer Institute, Assuit university hospitals
  • Cadeira de estudo: Eman A. Ismail, Assiut University Hospitals

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 (Antecipado)

1 de junho de 2022

Conclusão Primária (Antecipado)

1 de outubro de 2024

Conclusão do estudo (Antecipado)

1 de outubro de 2024

Datas de inscrição no estudo

Enviado pela primeira vez

2 de setembro de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de outubro de 2021

Primeira postagem (Real)

25 de outubro de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de outubro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de outubro de 2021

Última verificação

1 de outubro de 2021

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • Q123

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

produto fabricado e exportado dos EUA

Não

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Ensaios clínicos em Group I (BN10)

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