Skip to main content
OpenTrials
Completed

NCT Number: NCT02361775

Paravertebral Catheters for VATS Procedures

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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:

  • 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).
  • 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).
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paravertebral catheter

Device

A catheter is placed ultrasound guided at the T5 paravertebral level

opioid iv pca

Device

opioid pca consisting of hydromorphone

Ropivacaine

Drug

0.2% ropivacaine infused through paravertebral catheter

Other names: Naropin

Elastomeric Pump

Device

Elastomeric pump connected to paravertebral catheter

Other names: On Q

Primary outcomes

  1. Maximum NRS Pain score

    Time frame: 0-24 hours after surgery

    pain at movement or maximum in first 24 hours after surgery

Secondary outcomes

  1. total opioid use

    Time frame: the first 5 days after surgery

    total opioids converted to morphine equivalents

  2. length of stay

    Time frame: 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

Other outcomes

  1. the number of patients with presence of nausea and vomiting

    Time frame: the first 5 days postoperatively

    the number of patients who have nausea and or vomiting.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Ultrasound Guided Paravertebral Catheter Versus Patient Controlled Analgesia for Postoperative Pain Control in Video Assisted Thoracoscopic Surgery: A Prospective Outcomes Study

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 12, 2015
Registry last updated
Feb 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.