DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 use

length 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017