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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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02361775
Enrollment
50
Registered
2015-02-12
Start date
2012-07-31
Completion date
2014-10-31
Last updated
2015-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

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: 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.

Interventions

DEVICEParavertebral catheter

A catheter is placed ultrasound guided at the T5 paravertebral level

DEVICEopioid iv pca

opioid pca consisting of hydromorphone

DRUGRopivacaine

0.2% ropivacaine infused through paravertebral catheter

Elastomeric pump connected to paravertebral catheter

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Maximum NRS Pain score0-24 hours after surgerypain at movement or maximum in first 24 hours after surgery

Secondary

MeasureTime frameDescription
total opioid usethe first 5 days after surgerytotal opioids converted to morphine equivalents
length of staytime until patient is ready to be discharged or is discharged, expected 5 daysparticipants will be followed for duration of stay expected 5 days

Other

MeasureTime frameDescription
the number of patients with presence of nausea and vomitingthe first 5 days postoperativelythe number of patients who have nausea and or vomiting.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026