Paravertebral Catheters for VATS Procedures

NCT ID: NCT02361775

Last Updated: 2015-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-10-31

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.

Conditions

Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paravertebral catheter

a paravertebral catheter is placed and an elastomeric pump is connected to infuse 0.2% ropivacaine postoperatively

Group Type: EXPERIMENTAL

Paravertebral catheter

Intervention Type: DEVICE

A catheter is placed ultrasound guided at the T5 paravertebral level

Ropivacaine

Intervention Type: DRUG

0.2% ropivacaine infused through paravertebral catheter

Elastomeric Pump

Intervention Type: DEVICE

Elastomeric pump connected to paravertebral catheter

IV PCA

opioid PCA consisting of hydromorphone is connected to patient in the post anesthesia care unit

Group Type: ACTIVE_COMPARATOR

opioid iv pca

Intervention Type: DEVICE

opioid pca consisting of hydromorphone

Interventions

Paravertebral catheter

A catheter is placed ultrasound guided at the T5 paravertebral level

Intervention Type: DEVICE

opioid iv pca

opioid pca consisting of hydromorphone

Intervention Type: DEVICE

Ropivacaine

0.2% ropivacaine infused through paravertebral catheter

Intervention Type: DRUG

Elastomeric Pump

Elastomeric pump connected to paravertebral catheter

Intervention Type: DEVICE

Other Intervention Names

Naropin; On Q

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1201M09227

Identifier Type: -

Identifier Source: org_study_id