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The Impact of a Preoperative Nerve Block on the Consumption of Sevoflurane

23 de mayo de 2022 actualizado por: University of Alberta

Arthroscopic rotator cuff surgery of the shoulder is performed under general anesthesia. Pain control for after the surgery can be achieved purely with intravenous and oral pain medication or in combination with freezing of the nerves. Nerve freezing (nerve block) placed before surgery has the potential to substantially reduce the amount of inhaled anesthetic given to the patient during surgery. This can benefit the patient by minimizing the opioid usage after surgery and also reduce cost to the system in terms of duration of hospital stay. The purpose of the study is to investigate whether the inclusion of a nerve block to the general anesthetic for rotator cuff repair surgery will also reduce the amount of inhaled anesthetic and thereby lowering the environmental footprint from the anesthetic.

The investigators of the proposed study plan to quantify the amount of inhaled anesthetic used for each case and will compare how the consumption is affected by whether the nerve block is applied before or after surgery. Patients will have a nerve block catheter (interscalene catheter) placed under ultrasound-guidance prior to the induction of general anesthetic by an experienced regional anesthesiologist. The nerve block catheter will be bolused with a solution to which the anesthesiologist is blinded which will either be local anesthetic or normal saline (sham). The general anesthetic will be conducted according to a the protocol with the aim of maintaining a standard anesthetic depth monitored by patient state index (PSI). Measurements of the MAC-Value (minimum alveolar concentration) of inhaled anesthetic will be recorded every five minutes and the total amount of volatile anesthetic (in ml and ml/kg) will be noted down by a blinded observer. At the end of the case the anesthesiologist blinded to the solution will inject another solution (now a saline (sham) or local anesthetic before the patient is woken up.

Descripción general del estudio

Descripción detallada

Following ethics approval, eligible patients meeting the inclusion/exclusion criteria will be consented in pre-assessment unit or day surgery ward at least 2 hours prior to their surgery. Patients will then be randomized into two groups:

Interscalene nerve block catheter insertion with 20 mL 0.5% ropivacaine injection (Treatment group) Interscalene nerve block catheter insertion with 20 mL normal saline injection (Sham group)

The patient, anesthesia provider, data recorder, OR staff and Post Anaesthetic Care Unit (PACU) nurses, will be blinded at the beginning of the case. The patients consenting for the study and meeting the eligibility criteria for the study will be randomized to either group-1 (PRE-GA) or group-2 (POST-GA) . Prior to induction of general anesthesia, all patients will receive an interscalene nerve block catheter (Pajunk e-cath) inserted under ultrasound guidance using the catheter-over-needle technique by an acute pain physician who has been performing interscalene blocks under ultrasound guidance for at least 5 years. Successful catheter placement will be verified by ultrasound visualization of the injectate spread. Based on the randomization, each patient will receive a clear 10 mL syringe containing either the Treatment or the Sham solution. Patients in group PRE-GA will receive 10 ml of 0.5% ropivacaine through the catheter before the start of surgery and 10 ml of saline (0.9%) at the end of surgery. The patients in group POST-GA will receive 10 ml of saline (0.9%) before the start of surgery and 10 ml of 0.5% ropivacaine at the end of surgery. All study medications will be prepared by the principal investigator who will be unblinded to the patient allocation. All other team members will be blinded to the group allocation.

Following the interscalene nerve block catheter insertion, all patients will receive general anesthesia with a standardized protocol using intravenous administration of fentanyl (2 mcg/kg), propofol (2 mg/kg), and rocuronium (0.6 mg/kg). General anesthesia will initially be maintained with sevoflurane at 1.0 age-adjusted Minimal Alveolar Concentration (MAC). Subsequently, the age-adjusted MAC will be titrated to achieve an intraoperative PSI target of 25-50 (Sedline, Masimo®), and intraoperative heart rate (HR) and mean blood pressure (MBP) target of +/-30% baseline values. The anaesthesiologist will have the ability to administer IV boluses of analgesic (remifentanil 0.5mcg/kg) if the Patient State Index (PSI) is >50 and/or the MBP or HR is above 30% of baseline. Vasopressors such as phenylephrine (100 mcg IV bolus) and ephedrine (5 mg IV bolus) can be used as last-line therapy to treat hypotension that is unresponsive to MAC adjustments. The age-adjusted MAC value will be recorded every 5 minutes starting at the time of skin incision until the time of skin closure. In addition, intraoperative analgesic and vasopressor usage are recorded. After the conclusion of MAC recording and prior to emergence from general anesthesia, the anaesthesiologist will be unblinded to the randomized groups, and the patients who received Sham solution will be given 20 mL of the treatment solution via the interscalene catheter to ensure patients receive adequate analgesia postoperatively.

Postoperatively, patients will be transferred to recovery area where the distribution of the sensory or motor block will then be checked and recorded 30 minutes after arriving in PACU to document the success of the block in both groups by the nurses blinded to the group allocation. The Visual Analogue Pain Scale for pain will also be recorded in PACU at 0, 15, 30 and 45 minutes. Postoperative opioid consumption, nausea and vomiting scores and pan scores over the first 24 postoperative hours will also be collected for comparison.

Tipo de estudio

Intervencionista

Inscripción (Actual)

27

Fase

  • Fase 2
  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Alberta
      • Edmonton, Alberta, Canadá, T6G2G3
        • University of Alberta Hospital
      • St. Albert, Alberta, Canadá, T8N6C4
        • Sturgeon Community Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patients undergoing elective shoulder arthroscopy
  • Patients eligible for interscalene brachial plexus block
  • All adults > 18 years of age
  • Capable to give consent

Exclusion Criteria:

  • Patients who are unable to give consent
  • Local anaesthetic allergy
  • Hemidiaphragm paresis on the contralateral side to the block/surgery site
  • Bleeding diathesis
  • Coagulopathy
  • Pre-existing neurological deficits
  • Patients with a Body Mass Index >35
  • Patients with significant comorbidities, physiological limitations, and allergies that are unable to tolerate the protocolized induction and maintenance of anesthesia.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: PRE-GA
10 mL of 0.5% ropivacaine injection before the start of surgery and 10 ml of normal saline (0.9%) injection at the end of surgery through the interscalene catheter
Inyección de anestésico local
Sham injection
Comparador falso: POST-GA
10 ml of normal saline (0.9%) injection before the start of surgery and 0.5% ropivacaine injection at the end of surgery through the interscalene catheter
Inyección de anestésico local
Sham injection

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Average age-adjusted MAC of sevoflurane
Periodo de tiempo: Intra-operative measurement done at the end of anesthetic
The average age-adjusted end- tidal minimum alveolar concentration (MAC) will be calculated by averaging the end tidal MAC required to maintain the depth of anesthesia as measured by PSI between 25-50 intra-operatively. This will be compared between the two groups.
Intra-operative measurement done at the end of anesthetic

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sevoflurane consumption in ml/hr
Periodo de tiempo: Intra-operative - measurement done at the end of anesthetic
Total amount of Sevoflurane consumed during the intraoperative period will be measured and compared between the two groups
Intra-operative - measurement done at the end of anesthetic
Sevoflurane consumption in ml//kg/hr
Periodo de tiempo: Intra-operative - measurement done at the end of anesthetic
Total amount of Sevoflurane consumed/kg of patient body weight during the intraoperative period will be measured and compared between the two groups
Intra-operative - measurement done at the end of anesthetic
Intraoperative hemodynamics
Periodo de tiempo: Intraoperative period
Intraoperative heart rate (in beats/minute), systolic, diastolic and mean blood pressure (in mm Hg) will be documented at 5 minute interval and compared between the two groups
Intraoperative period
Uso intraoperatorio de opioides
Periodo de tiempo: Período intraoperatorio
El uso intraoperatorio de opioides de acción corta (en microgramos/kg) según el protocolo del estudio se registrará y comparará entre los dos grupos.
Período intraoperatorio
Postoperative opioid use in PACU
Periodo de tiempo: 24 postoperative hours
Total amount of opioids (in mg of morphine equivalents) in the PACU and over the first 24 postoperative hours will be recorded and compared between the two groups
24 postoperative hours
Maximum pain scores in the first 24 post-operative hours
Periodo de tiempo: 24 postoperative hours
Maximum pain scores will be recorded using numerical rating scale (NRS) of 0-10 (where 0=no pain and 10= maximum pain) on arrival to PACU and at 0,15,30, 45 minutes and at 24 postoperative hours and compared between the two groups
24 postoperative hours
Nausea and vomiting in the first 24 post-operative hours
Periodo de tiempo: 24 postoperative hours
Nausea scores (on a Likert scale of 1-4 where 1 = no nausea, 2= mild nausea, 3= moderate nausea and 4= severe nausea) and incidence of vomiting will be recorded on arrival to PACU and at 0,15,30, 45 minutes and at 24 postoperative hours and will be compared between the two groups
24 postoperative hours
24 hour opioid consumption
Periodo de tiempo: 24 postoperative hours
Frequency and total consumption of opioids (in morphine equivalents) over the first 24 postoperative hours will be recorded and compared between the two groups
24 postoperative hours
El puntaje de sedación en PACU
Periodo de tiempo: 1ª hora postoperatoria
Los puntajes de sedación se registrarán en intervalos de 15 minutos según la escala de sedación de Ramsay (1-6) y se compararán entre los dos grupos.
1ª hora postoperatoria
Block success
Periodo de tiempo: 1st postoperative hour
Sensory testing of the C5 and C6 dermatomes will be performed in the PACU at 30 minutes of arrival to PACU to document the success of the block
1st postoperative hour
Uso intraoperatorio de vasopresores
Periodo de tiempo: Período intraoperatorio
La cantidad y la frecuencia del uso intraoperatorio de vasopresores (fenilefrina en microgramos) se documentarán y compararán entre los dos grupos.
Período intraoperatorio

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Director de estudio: Vivian HY Ip, MD, University of Alberta
  • Investigador principal: Timur JP Özelsel, MD, University of Alberta
  • Silla de estudio: Rakesh V Sondekoppam, MD, University of Alberta

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de mayo de 2019

Finalización primaria (Actual)

1 de enero de 2022

Finalización del estudio (Actual)

1 de enero de 2022

Fechas de registro del estudio

Enviado por primera vez

9 de abril de 2018

Primero enviado que cumplió con los criterios de control de calidad

10 de mayo de 2018

Publicado por primera vez (Actual)

23 de mayo de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de mayo de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

23 de mayo de 2022

Última verificación

1 de mayo de 2022

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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