Paravertebral Catheter for Lung Transplant

Paravertebral Catheter Use for Postoperative Pain Control in Patients After Lung Transplant Surgery: A Prospective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Procedure: paravertebral catheter placement; Drug: 0.2% ropivacaine; Device: Elastomeric pump

Detailed Description

Following approval of the University of Minnesota Institutional Review Board, 33 consecutive adult patients (≥ 18 years of age) were observed from October 2013 to December 2014 who underwent either single or bilateral lung transplantation and received a continuous paravertebral block. The paravertebral catheters were placed within 1-2 day postoperatively in the intensive care unit. If the patient was too hemodynamically unstable or too critically ill to be placed in lateral decubitus position, the placement of the catheter was delayed or in some cases not performed (these patients were not included in study) They were placed via an in plane transverse technique. The ultrasound was placed on the patient's back at the T8-9 level with probe in transverse orientation. Then a 17-gauge tuohy needle was advanced lateral to medial in plane until beneath the transverse process upon which a test dose of 3-5 mL of 1.5% lidocaine with 1:200,000 epinephrine was injected to see adequate spread. The catheter was then fed 1 centimeter past the tip of the tuohy needle and needle was withdrawn. All catheters were confirmed to be in correct position with real time local anesthetic injection and secured with skin glue and occlusive dressing. Each was performed with the patient in the left lateral decubitus position for the right catheter and right lateral decubitus position for the left catheter. The paravertebral catheters remained in place for up to seven days postoperatively in unilateral lung transplants and up to ten days postoperatively in bilateral lung transplants. During that time an infusion of 0.2% ropivacaine was infused at a rate of 0.2-0.25 ml/kg/hour through an elastomeric pump (ON Q Halyard Health).

The outcome measured were minimal and maximum pain scores from the first 7 days post paravertebral catheter placement (rated on an 11-point numeric rating scale; 0=no pain, 10=worst pain imaginable). The acute pain Nurse Practitioners, bedside nurses, or acute pain anesthesiology residents collected the pain scores. Additional outcomes of interest included postsurgical opioid use through postsurgical day 7, and length of hospital stay. Patients were asked daily if they experienced nausea/vomiting, however, Nursing notes and physician progress notes were also evaluated if patients experienced any adverse events or nausea and vomiting. Demographics such as age and weight were recorded in addition to length of surgery and time spent in the hospital before discharge.

• Study Type: Observational
• Enrollment (Actual): 33

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single lung transplant paravertebral catheter placement; Those patients who underwent single lung transplant either right or left.	Procedure: paravertebral catheter placement; a thoracic paravertebral catheter was placed and connected to an elastomeric pump with a continuous infusion of 0.2% ropivacaine; Drug: 0.2% ropivacaine; 0.2% ropivacaine was infused through the elastomeric device; Device: Elastomeric pump; An elastomeric pump was connected to the paravertebral catheter
bilateral lung transplant paravertebral catheter placement; those patients who underwent bilateral lung transplantation	Procedure: paravertebral catheter placement; a thoracic paravertebral catheter was placed and connected to an elastomeric pump with a continuous infusion of 0.2% ropivacaine; Drug: 0.2% ropivacaine; 0.2% ropivacaine was infused through the elastomeric device; Device: Elastomeric pump; An elastomeric pump was connected to the paravertebral catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal Pain score	VAS pain scores assessed by bedside nurse on 0-10 scale which is minimum felt	each post catheter day from post operative day 1 to day 7
total opioid use	opioids were normalized to milligrams of IV morphine	each post catheter day from postoperative day 1 to day 7
length of stay	participants followed for duration of stay expected average 3 weeks	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

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 2, 2015
• First Submitted That Met QC Criteria: February 27, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Estimate): March 5, 2015
• Last Update Submitted That Met QC Criteria: February 27, 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: 1309M42821