Paravertebral Catheters for VATS Procedures

University of Minnesota (UMN)

Status and phase: Completed; Early Phase 1

Conditions: Acute Pain

Treatments: Device: Paravertebral catheter; Device: opioid iv pca; Device: Elastomeric Pump; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02361775

1201M09227

Details and patient eligibility

About

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.

Full 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).

3. 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Paravertebral catheter

Experimental group

Description:

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

Treatment:

Drug: Ropivacaine

Device: Paravertebral catheter

Device: Elastomeric Pump

IV PCA

Active Comparator group

Description:

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

Treatment:

Device: opioid iv pca