Paravertebral Catheters for VATS Procedures

Early Phase 1

Completed

• Conditions: Acute Pain
• Interventions: Device: opioid iv pca; Device: Paravertebral catheter; Drug: Ropivacaine; Device: Elastomeric Pump

• Registration Number: NCT02361775
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-02
• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-02-11
• Last Update Submitted: 2015-02-11
• Study First Posted: 2015-02-12
• Last Update Posted: 2015-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV PCA	opioid iv pca	opioid PCA consisting of hydromorphone is connected to patient in the post anesthesia care unit
Paravertebral catheter	Elastomeric Pump	a paravertebral catheter is placed and an elastomeric pump is connected to infuse 0.2% ropivacaine postoperatively
Paravertebral catheter	Paravertebral catheter	a paravertebral catheter is placed and an elastomeric pump is connected to infuse 0.2% ropivacaine postoperatively
Paravertebral catheter	Ropivacaine	a paravertebral catheter is placed and an elastomeric pump is connected to infuse 0.2% ropivacaine postoperatively

Primary Outcome Measures

Name	Time	Method
Maximum NRS Pain score	0-24 hours after surgery	pain at movement or maximum in first 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
total opioid use	the first 5 days after surgery	total opioids converted to morphine equivalents
length of stay	time until patient is ready to be discharged or is discharged, expected 5 days	participants will be followed for duration of stay expected 5 days