Clinical trial NCT02361775: Paravertebral Catheters for VATS Procedures
Official title: Ultrasound Guided Paravertebral Catheter Versus Patient Controlled Analgesia for Postoperative Pain Control in Video Assisted Thoracoscopic Surgery: A Prospective Outcomes Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Acute Pain
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Maximum NRS Pain score
timeFrame: 0-24 hours after surgery
Secondary outcomes:
measure: total opioid use
timeFrame: the first 5 days after surgery
measure: length of stay
timeFrame: time until patient is ready to be discharged or is discharged, expected 5 days
Other outcomes:
measure: the number of patients with presence of nausea and vomiting
timeFrame: the first 5 days postoperatively
Locations:
Study officials:
References: