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Comparison of Three Different Pain Blocks for Subjects Undergoing VATS (Video Assisted Thoracoscopic Surgery) Procedure. (VATS)

7 de janeiro de 2021 atualizado por: Yar Yeap, Indiana University

Randomized Prospective Study Comparing Paravertebral Catheters, Single Shot Paravertebral Block, Thoracic Epidural, for Postoperative Analgesia Following Video-assisted Thoracoscopic Surgery

The purpose of this study is to compare three different pain control methods on subjects who are scheduled to undergo VATS (video-assisted thoracoscopic surgery) procedures. The study will compare their pain scores, narcotic needs, patient satisfaction scores, and narcotic side effects.

Visão geral do estudo

Descrição detalhada

All patients will be consented on the morning of surgery. All the thoracic epidurals and ultrasound-guided paravertebral blocks will be placed preoperatively. The procedures will be done using sterile technique with masks, hats, and sterile gloves. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.

Thoracic epidurals will be placed using the Arrow thoracic epidural kit. The epidural will be placed at the appropriate level to cover the entry site for the VATS procedure. Placement will be determined by anatomical landmarks. The epidural needle will be advanced toward the epidural space utilizing a Paramedian approach and loss-of-resistance technique. A sterile catheter will then be secured in place and the epidural infusion will be started at the end of the case.

Ultrasound guided paravertebral catheter and single shot paravertebral block will be accomplished using an ultrasound transducer at the thoracic level. This will be done using an in-plane or out-of-plane approach, at the discretion of the anesthesia staff performing the procedure. Then a needle will be inserted the needle into the paravertebral space and local anesthetic injected. Then a catheter will be placed within the injectate and secured in place in the case of the paravertebral catheter. The 0.2% Ropivicaine will be delivered by OnQ pump.

General anesthesia will be induced and the patient will be placed in the lateral position for the VATS procedure. The patients will be intubated with dual lumen endotracheal tubes and placed on one-lung ventilation for the procedure.

All patients will receive intravenous patient-controlled analgesia (PCA hydromorphone) post-operatively for breakthrough pain. They will also be scheduled on PO acetaminophen. PO oxycodone PRN will be started on POD 1 once patients tolerate diet.

Opioid usage at 1,24,48,72 hours after the block will be recorded by a member of the research team. Pain scores at rest and on movement (knee flexion) will be measured by the investigator using Visual Analog Scale (VAS). Nausea will be measured using a categorical scoring system (none=0; mild=1; moderate=2; severe=3). Sedation scores will also be assessed by a member of the study team using a sedation scale (awake and alert=0; quietly awake=1; asleep but easily roused=2; deep sleep=3). All these parameters will be measured at 1, 24, 48 and 72 hours after the epidural or PVB. Patients will be encouraged to ambulate on postoperative day 1 under supervision.

All catheters will be removed by APS (Acute Pain Service) while patients are still in the hospital. APS will continue to follow the patients until catheter removal. Patient's hospital length of stay and readmission rate will be recorded from NSQIP (National Surgical Quality Improvement Program) data.

All patients will receive a phone call 6 months after surgery for assessment for chronic post-surgical pain. Patients will be assessed by a member of the research team over the phone. They will be assessed on their pain score and narcotic usage by using the Brief Pain Inventory. Study participation will conclude after the 6 month follow questionnaire has been completed.

Tipo de estudo

Intervencional

Inscrição (Real)

147

Estágio

  • Fase 3

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.

Locais de estudo

    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Indiana 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

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

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Pt undergoing VATS procedure at Indiana University Hospital
  • ASA 1,2,3 or 4
  • Age 18 or older, male or female
  • Desires Regional anesthesia for postoperative pain control

Exclusion Criteria:

  • Any contraindication for Thoracic Epidural or Paravertebral block
  • History of substance abuse in the past 6 months
  • Patient staying intubated after surgery
  • Known allergy or other contraindications to the study medications , which include dilaudid, bupivacaine, ropivacaine

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: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Group #1
US Guided Single Shot Paravertebral Block
Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.
Outros nomes:
  • US Guided Single Shot Paravertebral Block
Comparador Ativo: Group #2
US Guided Paravertebral Catheter
Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.
Outros nomes:
  • US Guided Paravertebral Catheter
Comparador Ativo: Group #3
Thoracic Epidural
Epidural catheter will be placed in the thoracic region prior to surgery.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
The Primary Endpoint of This Study Will be VAS Pain Score at 24 Hours
Prazo: Pain scores will be measured 24 hours after surgery.
The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using "units on a scale" of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Pain scores will be measured 24 hours after surgery.
The Primary Endpoint of This Study Will be VAS Pain Score at 48 Hours
Prazo: Pain scores will be measured 48 hours after surgery.
The VAS scores will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using"units on a scale" scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Pain scores will be measured 48 hours after surgery.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Secondary Endpoint Includes Total Intravenous Opioid Consumption at 72 Hours
Prazo: Opioid consumption will be measured at 1 hour post op, 24,48, and 72 hours post op. The total amount will be recorded.
Opioid consumption will be collected by a study team member post operatively up to 3 days per protocol time requirements
Opioid consumption will be measured at 1 hour post op, 24,48, and 72 hours post op. The total amount will be recorded.

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Average Nausea Scores Over 72 Hours
Prazo: Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the surgery.The scores will then be averaged.
Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as 0=none, 1=mild, 2=moderate, or 3=severe
Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the surgery.The scores will then be averaged.
Average Sedation Scores Over 72 Hours
Prazo: Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the sugery. The scores will then be averaged.
Sedation scores will be documented by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is 0=awake and alert, 1=quietly awake, 2=asleep and arousable, or 3=deep sleep.
Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the sugery. The scores will then be averaged.
Subjects Overall Satisfaction Scores
Prazo: post operatively at hour 24
Subjects will be followed up at 24 hours post operatively by a study team member to document patient overall satisfaction scores. Score was recorded as 0=dissatisfied, 1=satisfied, 2=very satisfied.
post operatively at hour 24
Subjects Overall Satisfaction Scores
Prazo: post operatively at hour 48
Subjects will be followed up at 48 hours post operatively by a study team member to document patient overall satisfaction scores. Scores will be recorded as 0=dissatisfied, 1=satisfied, 2=very satisfied.
post operatively at hour 48

Colaboradores e Investigadores

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Patrocinador

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

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Datas Principais do Estudo

Início do estudo (Real)

7 de fevereiro de 2017

Conclusão Primária (Real)

30 de julho de 2018

Conclusão do estudo (Real)

30 de julho de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

22 de março de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de maio de 2017

Primeira postagem (Real)

12 de maio de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de janeiro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de janeiro de 2021

Última verificação

1 de janeiro de 2021

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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