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
About this trial
This is an interventional treatment trial for Acute Pain
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
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
NCT ID
NCT02361775
First Posted
February 3, 2015
Last Updated
February 11, 2015
Sponsor
University of Minnesota
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
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Paravertebral Catheters for VATS Procedures
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