Paravertebral Catheters for VATS Procedures

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361775
• Other study ID #: 1201M09227
• Status: Completed
• Phase: Phase 0
• First received: February 3, 2015
• Last updated: February 11, 2015
• Start date: July 2012
• Est. completion date: October 2014

Study information

• Verified date: February 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain

Intervention

Device:
• Paravertebral catheter
A catheter is placed ultrasound guided at the T5 paravertebral level
• opioid iv pca
opioid pca consisting of hydromorphone

Drug:
• Ropivacaine
0.2% ropivacaine infused through paravertebral catheter

Device:
• Elastomeric Pump
Elastomeric pump connected to paravertebral catheter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	Maximum NRS Pain score	pain at movement or maximum in first 24 hours after surgery	0-24 hours after surgery	No
Secondary	total opioid use	total opioids converted to morphine equivalents	the first 5 days after surgery	No
Secondary	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	No