Paravertebral Catheter for Lung Transplant

NCT02380417 | Completed

• 1 other identifier: 1309M42821
• Study Type: observational
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective observational trial of patient undergoing lung transplantation who have a thoracic paravertebral catheter(s) placed for postoperative pain control. Patients pain scores and opioid use were evaluated for 7 days after placement as well as any complications, opioid adverse events, and length of stay.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• Maximal Pain score

  VAS pain scores assessed by bedside nurse on 0-10 scale which is maximum felt

  each post catheter day from postoperative day 1 to day 7

Secondary Outcomes (4)

• Minimal Pain score

  each post catheter day from post operative day 1 to day 7

• total opioid use

  each post catheter day from postoperative day 1 to day 7

• length of stay

  from end of surgery evaluated until patient left hospital with expected average up to 3 weeks

• number of patients with nausea in the postoperative period

  from day of surgery evaluated up to post catheter day 7

Study Arms (2)

Single lung transplant paravertebral catheter placement

Those patients who underwent single lung transplant either right or left.

Procedure: paravertebral catheter placement; Drug: 0.2% ropivacaine; Device: Elastomeric pump

bilateral lung transplant paravertebral catheter placement

those patients who underwent bilateral lung transplantation

Procedure: paravertebral catheter placement; Drug: 0.2% ropivacaine; Device: Elastomeric pump

Interventions

paravertebral catheter placement PROCEDURE

a thoracic paravertebral catheter was placed and connected to an elastomeric pump with a continuous infusion of 0.2% ropivacaine

Single lung transplant paravertebral catheter placement; bilateral lung transplant paravertebral catheter placement

0.2% ropivacaine DRUG

0.2% ropivacaine was infused through the elastomeric device

Single lung transplant paravertebral catheter placement; bilateral lung transplant paravertebral catheter placement

Elastomeric pump DEVICE

An elastomeric pump was connected to the paravertebral catheter

Single lung transplant paravertebral catheter placement; bilateral lung transplant paravertebral catheter placement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who presented for a lung transplant and had a clamshell incision either single or bilateral.

You may qualify if:

• lung transplant
• clamshell incision
• received paravertebral catheter within 2 days of surgery

You may not qualify if:

• non english speaking
• remained intubated for greater than 3 days postoperatively
• midline incision
• allergy to local anesthetics

Sponsors & Collaborators

• University of Minnesota: lead

MeSH Terms

Conditions

Acute Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: March 5, 2015
• Study Start: October 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 5, 2015

Record last verified: 2015-02