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Paravertebral Catheters for VATS Procedures

Primary Purpose

Acute Pain

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Paravertebral catheter
opioid iv pca
Ropivacaine
Elastomeric Pump
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • All patients undergoing elective VATS.

Exclusion Criteria:

  • • Previous difficult airway or multiple previous intubations

    • History of myasthenic syndrome
    • Systemic infection
    • Pre-existing sensory deficit
    • PT >14 or PTT >40 sec
    • Platelet count less than 50,000
    • Creatinine > 1.5
    • Allergy to local anesthetics
    • Patients who remain intubated for one week after surgery or who are unable to provide information as to their feelings of pain post-operatively for the first week post-operatively
    • Use of a spinal or epidural anesthetic for surgery
    • Daily use of opioid for more than a week
    • Lack of patient cooperation
    • Contraindication to regional anesthesia

      • Infection at injection site
      • Inability to guarantee sterile equipment or sterile conditions for the block
      • Patient refusal
      • Risk of local anesthetic toxicity
      • Coagulopathy or bleeding disorder
      • Severe respiratory disease (where the patient depends on intercostal muscle function for ventilation);
      • Ipsilateral diaphragmatic paresis;
      • Severe spinal deformities (kyphosis or scoliosis)
      • Previous thoracotomy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Paravertebral catheter

    IV PCA

    Arm Description

    a paravertebral catheter is placed and an elastomeric pump is connected to infuse 0.2% ropivacaine postoperatively

    opioid PCA consisting of hydromorphone is connected to patient in the post anesthesia care unit

    Outcomes

    Primary Outcome Measures

    Maximum NRS Pain score
    pain at movement or maximum in first 24 hours after surgery

    Secondary Outcome Measures

    total opioid use
    total opioids converted to morphine equivalents
    length of stay
    participants will be followed for duration of stay expected 5 days

    Full Information

    First Posted
    February 3, 2015
    Last Updated
    February 11, 2015
    Sponsor
    University of Minnesota
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02361775
    Brief Title
    Paravertebral Catheters for VATS Procedures
    Official Title
    Ultrasound Guided Paravertebral Catheter Versus Patient Controlled Analgesia for Postoperative Pain Control in Video Assisted Thoracoscopic Surgery: A Prospective Outcomes Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2012 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Minnesota

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Level I randomized prospective outcomes study comparing two groups of patients. One group will receive Dilaudid patient controlled analgesia (PCA) post-operatively. The other will receive an ultrasound guided paravertebral block with indwelling paravertebral catheter with an infusion of 0.2% Ropivicaine post-operatively and a PCA.
    Detailed Description
    Design: Level I randomized prospective outcomes study comparing two groups of patients. One group will receive Dilaudid patient controlled analgesia (PCA) post-operatively. The other will receive an ultrasound guided paravertebral block with indwelling paravertebral catheter with an infusion of 0.2% Ropivicaine post-operatively and a PCA. Sample Size: 50 patients Study Duration: Approximately 24 months Population:. Patients presenting to the University of Minnesota Medical Center for elective Video Assisted Thoracoscopic Surgery (VATS), for thoracic, lung, or mediastinal lesions or masses. Primary Objective: To determine if post-operative paravertebral catheters in patients with elective VATS procedures result in decreased pain compared to patients treated with PCA for post-operative pain. Secondary Objectives: To determine whether the use of paravertebral catheters impacts the length of ICU and hospital stay for patients, compared to a PCA in patients undergoing elective Video Assisted Thoracoscopic Surgery (VATS). To determine whether the use of paravertebral catheters leads to lower risk of complications, compared to use of a PCA in patients undergoing elective Video Assisted Thoracoscopic Surgery (VATS). 2. Synopsis and Medical Application: Specific Aims: Primary Hypothesis: Paravertebral catheters will result in improved pain control relative to PCA for post-operative pain from thoracic surgery. Secondary Hypothesis: Paravertebral catheters will result in fewer hospital days and improved subjective respiratory function compared to patients in the PCA group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Paravertebral catheter
    Arm Type
    Experimental
    Arm Description
    a paravertebral catheter is placed and an elastomeric pump is connected to infuse 0.2% ropivacaine postoperatively
    Arm Title
    IV PCA
    Arm Type
    Active Comparator
    Arm Description
    opioid PCA consisting of hydromorphone is connected to patient in the post anesthesia care unit
    Intervention Type
    Device
    Intervention Name(s)
    Paravertebral catheter
    Intervention Description
    A catheter is placed ultrasound guided at the T5 paravertebral level
    Intervention Type
    Device
    Intervention Name(s)
    opioid iv pca
    Intervention Description
    opioid pca consisting of hydromorphone
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine
    Other Intervention Name(s)
    Naropin
    Intervention Description
    0.2% ropivacaine infused through paravertebral catheter
    Intervention Type
    Device
    Intervention Name(s)
    Elastomeric Pump
    Other Intervention Name(s)
    On Q
    Intervention Description
    Elastomeric pump connected to paravertebral catheter
    Primary Outcome Measure Information:
    Title
    Maximum NRS Pain score
    Description
    pain at movement or maximum in first 24 hours after surgery
    Time Frame
    0-24 hours after surgery
    Secondary Outcome Measure Information:
    Title
    total opioid use
    Description
    total opioids converted to morphine equivalents
    Time Frame
    the first 5 days after surgery
    Title
    length of stay
    Description
    participants will be followed for duration of stay expected 5 days
    Time Frame
    time until patient is ready to be discharged or is discharged, expected 5 days
    Other Pre-specified Outcome Measures:
    Title
    the number of patients with presence of nausea and vomiting
    Description
    the number of patients who have nausea and or vomiting.
    Time Frame
    the first 5 days postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: • All patients undergoing elective VATS. Exclusion Criteria: • Previous difficult airway or multiple previous intubations History of myasthenic syndrome Systemic infection Pre-existing sensory deficit PT >14 or PTT >40 sec Platelet count less than 50,000 Creatinine > 1.5 Allergy to local anesthetics Patients who remain intubated for one week after surgery or who are unable to provide information as to their feelings of pain post-operatively for the first week post-operatively Use of a spinal or epidural anesthetic for surgery Daily use of opioid for more than a week Lack of patient cooperation Contraindication to regional anesthesia Infection at injection site Inability to guarantee sterile equipment or sterile conditions for the block Patient refusal Risk of local anesthetic toxicity Coagulopathy or bleeding disorder Severe respiratory disease (where the patient depends on intercostal muscle function for ventilation); Ipsilateral diaphragmatic paresis; Severe spinal deformities (kyphosis or scoliosis) Previous thoracotomy

    12. IPD Sharing Statement

    Learn more about this trial

    Paravertebral Catheters for VATS Procedures

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