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Optimal Timing of Intercostal Nerve Blocks During Video-Assisted Thoracic Surgeries

This study is currently recruiting participants.
Verified November 2016 by Nader D Nader, University at Buffalo
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980835
First Posted: December 2, 2016
Last Update Posted: December 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Veteran Affairs Western New York Healthcare System
Information provided by (Responsible Party):
Nader D Nader, University at Buffalo
  Purpose
Intercostal nerve block, performed under the guidance of videoscope, is a part of standard anesthesia procedures for patients receiving Video-Assisted Thoracic Surgeries. In this double-blind, prospective, multi-center, randomized, controlled clinical trial the investigators aim to compare preemptive versus post-closure intercostal injection of ropivacaine in controlling post-video-assisted thoracotomy pain.

Condition Intervention
Video-Assisted Thoracic Surgery Video-Assisted Thoracoscopic Surgery Drug: Normal Saline Drug: Ropivacaine Drug: Epinephrine Drug: Dexamethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimal Timing of Intercostal Nerve Blocks During Video-Assisted Thoracic Surgeries

Further study details as provided by Nader D Nader, University at Buffalo:

Primary Outcome Measures:
  • Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score [ Time Frame: 0 ]
    VAS scores at rest will be recorded right after surgery and compared in both groups

  • Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score [ Time Frame: 6 hours ]
    VAS scores at rest will be recorded 6 hours after surgery and compared in both groups

  • Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score [ Time Frame: 12 hours ]
    VAS scores at rest will be recorded 12 hours after surgery and compared in both groups

  • Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score [ Time Frame: 18 hours ]
    VAS scores at rest will be recorded 18 hours after surgery and compared in both groups

  • Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score [ Time Frame: 24 hours ]
    VAS scores at rest will be recorded 24 hours after surgery and compared in both groups

  • Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score [ Time Frame: 48 hours ]
    VAS scores at rest will be recorded 48 hours after surgery and compared in both groups

  • Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score [ Time Frame: 72 hours ]
    VAS scores at rest will be recorded 72 hours after surgery and compared in both groups


Secondary Outcome Measures:
  • Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC) [ Time Frame: 12 hours ]
    Postoperative delirium profiles will be measured 12 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC)

  • Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC) [ Time Frame: 24 hours ]
    Postoperative delirium profiles will be measured 24 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC)

  • Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC) [ Time Frame: 36 hours ]
    Postoperative delirium profiles will be measured 36 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC)

  • Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC) [ Time Frame: 48 hours ]
    Postoperative delirium profiles will be measured 48 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC)

  • PaO2/FIO2 ratio right after surgery [ Time Frame: 0 hours ]
    PaO2 (mmHg kPa) and FIO2 (percent) will be recorded from atrial blood gas examination and the ratio will be calculated

  • Total hospital length of stay [ Time Frame: up to 2 weeks ]
    The investigators will assess length of stay by evaluating medical records and calculate length of stay in days, using date of discharge and date of admission

  • Need for non-invasive positive pressure ventilation (NIPPV) [ Time Frame: up to two weeks ]
    The investigators will assess the need for NIPPV by evaluating medical records to asses if patients received NIPPV with the discretion of the managing physician during their hospitalization

  • Need for mechanical ventilation [ Time Frame: up to two weeks ]
    The investigators will assess the need for mechanical ventilation by evaluating medical records to asses if patients received mechanical ventilation with the discretion of the managing physician during their hospitalization


Estimated Enrollment: 220
Study Start Date: September 2016
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Patients who receive injections of A (a total of a 10 mL-solution that consists of 9 mL of ropivacaine HCl 0.5% and 1 mL of dexamethasone 4mg/mL preparation) at the beginning of surgery and second set of injections containing a mixture of B (contains 10 mL of 0.9% normal saline) and C (a total 25 mL solution that consists of 24 mL of ropivacaine HCl 0.5%, 1 mL of dexamethasone-4mg/mL preparation, and 0.125 mL of epinephrine-1:1000 preparation) prior to the closure
Drug: Normal Saline
Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate B contains 10 mL of 0.9% normal saline.
Drug: Ropivacaine
Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate A and C contain 9 and 24 mL of ropivacaine HCl 0.5%, respectively.
Drug: Epinephrine
Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate C contains 0.125 mL of epinephrine-1:1000 preparation.
Drug: Dexamethasone
Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectates A and C both contain 1 mL of dexamethasone 4mg/mL preparation.
Active Comparator: Control
Participants who receive injection of B (contains 10 mL of 0.9% normal saline) at the beginning of surgery and injectate A (a total of a 10 mL-solution that consists of 9 mL of ropivacaine HCl 0.5% and 1 mL of dexamethasone 4mg/mL preparation) and injectate C (a total 25 mL solution that consists of 24 mL of ropivacaine HCl 0.5%, 1 mL of dexamethasone-4mg/mL preparation, and 0.125 mL of epinephrine-1:1000 preparation) at the end of procedure prior to the closure (which mimics standard care) is the control group
Drug: Normal Saline
Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate B contains 10 mL of 0.9% normal saline.
Drug: Ropivacaine
Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate A and C contain 9 and 24 mL of ropivacaine HCl 0.5%, respectively.
Drug: Epinephrine
Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate C contains 0.125 mL of epinephrine-1:1000 preparation.
Drug: Dexamethasone
Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectates A and C both contain 1 mL of dexamethasone 4mg/mL preparation.

Detailed Description:
The design of the study is a double-blind, prospective, multi-center, randomized, controlled clinical trial of preemptive vs. post-closure intercostal injection of ropivacaine in controlling post-video-assisted thoracotomy (VATS) pain. In standard intercostal nerve block procedures, the contents of A (a total of a 10 mL-solution that consists of 9 mL of ropivacaine HCl 0.5% and 1 mL of dexamethasone 4mg/mL preparation) and C (a total 25 mL solution that consists of 24 mL of ropivacaine HCl 0.5%, 1 mL of dexamethasone-4mg/mL preparation, and 0.125 mL of epinephrine-1:1000 preparation) are combined into one set of injections injected into the intercostal spaces of T5-6, T6-7, T7-8, T8-9 and T9-10, with each intercostal spaces receives about 7 mL of combined A and C solutions (each intercostal space receives 2 mL of A and about 5 mL of C). In this study, the intercostal nerve block is split into two sets of injections: one set of injections at the beginning of VATS, and the other set right before closure. Therefore the investigators consider both sets of injections as research procedures. Patients will be randomly assigned to receive a preemptive 2mL-injection of A or injection of B (contains 10 mL of 0.9% normal saline) at each intercostal space as previously delineated by the operating surgeon. Both the research team and the surgical team will be blind to the nature of the injectates during surgery. As parts of the standard care procedures, all patients will be monitored with non-invasive ASA standard in addition to invasive arterial blood pressure monitoring. Prior to the closure, patients who receive injections of A at the beginning of surgery will receive the second set of injections containing a mixture of B and C (5 mL of solution C is given at each intercostal space) at the intercostal spaces as previously delineated. Patients who receive injections of B at the beginning of surgery will receive the second set of injections containing a mixture of A and C (5 mL of solution C is given at each intercostal space). The investigators will group the patients who are assigned to receive injectate A at the end of the surgery as the control group. Because the injectate A and injectate C are usually given together in one set of injections at the same anatomical locations in standard intercostal nerve block procedures, the intercostal block received by the control group will closely resemble the procedures performed in standard intercostal nerve block. Patients who receive injectate A at the beginning of surgery are grouped as experimental group. Regardless of the group assignment, the total dosage of ropivacaine and dexamethasone given to a patient will be equal to the dosage given under the standard care procedures. Post operative pain, ventilatory profile and length of hospital stay will be compared between two study arms.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients will be eligible to enroll in this study if they:

  • Have physical status within ASA class II or III
  • Are between 18 and 85 years of age
  • Are candidates for VATS
  • Are able to complete VAS assessments
  • Are competent to sign the informed consent form

Exclusion Criteria:

Patients will not be enrolled in this study if they:

  • Are pregnant
  • Have allergy to ropivacaine or hydromorphone
  • Have renal insufficiency (eGFR<60mL/min/1.73m2)
  • Have hepatic insufficiency (AST, ALT, or both >60 U/L) or cirrhosis
  • Have a predicted postoperative forced vital capacity (FVC) of <40%, predicted forced expiratory volume at 1s (FEV1) <40%
  • Have coagulopathy (platelet count<50000, INR>2, or both)
  • Have a history of opioid addiction, chronically taking opioids, currently taking high dose of opioids or currently taking opioid agonist+antagonist (e.g. Suboxone®)
  • Are taking nonsteroidal anti-inflammatory drug, including aspirin, within a week prior to surgery (since the analgesic effects of NSAID drugs may become confounding factors).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980835


Locations
United States, New York
VA Western New York Healthcare System Recruiting
Buffalo, New York, United States, 14215
Contact: Lindsay Masterson    716-862-6527    Lindsay.Masterson@va.gov   
Principal Investigator: Nader Nader, MD, PHD         
Sub-Investigator: Geofrey Hobika, MD         
Sub-Investigator: Miriam Huang, MD         
Sub-Investigator: Leili Pourafkari, MD         
Sponsors and Collaborators
University at Buffalo
Veteran Affairs Western New York Healthcare System
  More Information

Responsible Party: Nader D Nader, Professor and Senior Vice Chair, University at Buffalo
ClinicalTrials.gov Identifier: NCT02980835     History of Changes
Other Study ID Numbers: 721921
First Submitted: November 22, 2016
First Posted: December 2, 2016
Last Update Posted: December 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators don't plan to make individual participant data (IPD) available to other researchers.

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Epinephrine
Racepinephrine
Epinephryl borate
Ropivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists