Paravertebral Catheters for VATS Procedures
Information source: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Pain
Intervention: Paravertebral catheter (Device); opioid iv pca (Device); Ropivacaine (Drug); Elastomeric Pump (Device)
Phase: Phase 0
Status: Completed
Sponsored by: University of Minnesota - Clinical and Translational Science Institute
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.
Clinical Details
Official title: Ultrasound Guided Paravertebral Catheter Versus Patient Controlled Analgesia for Postoperative Pain Control in Video Assisted Thoracoscopic Surgery: A Prospective Outcomes Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Maximum NRS Pain score
Secondary outcome: total opioid uselength of stay
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:
1. 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).
2. 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: July 2012
Last updated: February 11, 2015
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