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

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Device: Paravertebral catheter; Drug: Ropivacaine; Device: Elastomeric Pump; Device: opioid iv 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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paravertebral catheter; a paravertebral catheter is placed and an elastomeric pump is connected to infuse 0.2% ropivacaine postoperatively	Device: Paravertebral catheter; A catheter is placed ultrasound guided at the T5 paravertebral level; Drug: Ropivacaine; 0.2% ropivacaine infused through paravertebral catheter; Other Names: Naropin; Device: Elastomeric Pump; Elastomeric pump connected to paravertebral catheter; Other Names: On Q
Active Comparator: IV PCA; opioid PCA consisting of hydromorphone is connected to patient in the post anesthesia care unit	Device: opioid iv pca; opioid pca consisting of hydromorphone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum NRS Pain score	pain at movement or maximum in first 24 hours after surgery	0-24 hours after surgery

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
the number of patients with presence of nausea and vomiting	the number of patients who have nausea and or vomiting.	the first 5 days postoperatively

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: February 11, 2015
• First Posted (Estimate): February 12, 2015

Study Record Updates

• Last Update Posted (Estimate): February 12, 2015
• Last Update Submitted That Met QC Criteria: February 11, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 1201M09227