Paravertebral Catheters for VATS Procedures
Ultrasound Guided Paravertebral Catheter Versus Patient Controlled Analgesia for Postoperative Pain Control in Video Assisted Thoracoscopic Surgery: A Prospective Outcomes Study
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jul 2012
Typical duration for early_phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 3, 2015
CompletedFirst Posted
Study publicly available on registry
February 12, 2015
CompletedFebruary 12, 2015
February 1, 2015
2.3 years
February 3, 2015
February 11, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum NRS Pain score
pain at movement or maximum in first 24 hours after surgery
0-24 hours after surgery
Secondary Outcomes (2)
total opioid use
the first 5 days after surgery
length of stay
time until patient is ready to be discharged or is discharged, expected 5 days
Other Outcomes (1)
the number of patients with presence of nausea and vomiting
the first 5 days postoperatively
Study Arms (2)
Paravertebral catheter
EXPERIMENTALa paravertebral catheter is placed and an elastomeric pump is connected to infuse 0.2% ropivacaine postoperatively
IV PCA
ACTIVE COMPARATORopioid PCA consisting of hydromorphone is connected to patient in the post anesthesia care unit
Interventions
A catheter is placed ultrasound guided at the T5 paravertebral level
0.2% ropivacaine infused through paravertebral catheter
Elastomeric pump connected to paravertebral catheter
Eligibility Criteria
You may qualify if:
- All patients undergoing elective VATS.
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2015
First Posted
February 12, 2015
Study Start
July 1, 2012
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
February 12, 2015
Record last verified: 2015-02