Paravertebral Catheter for Lung Transplant

NCT ID: NCT02380417

Last Updated: 2015-03-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-12-31

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.

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 The catheter was then fed 1 centimeter past the tip of the tuohy needle and needle was withdrawn.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.

Conditions

Acute Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Single lung transplant paravertebral catheter placement

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

paravertebral catheter placement

Intervention Type: PROCEDURE

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

0.2% ropivacaine

Intervention Type: DRUG

0.2% ropivacaine was infused through the elastomeric device

Elastomeric pump

Intervention Type: DEVICE

An elastomeric pump was connected to the paravertebral catheter

bilateral lung transplant paravertebral catheter placement

those patients who underwent bilateral lung transplantation

paravertebral catheter placement

Intervention Type: PROCEDURE

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

0.2% ropivacaine

Intervention Type: DRUG

0.2% ropivacaine was infused through the elastomeric device

Elastomeric pump

Intervention Type: DEVICE

An elastomeric pump was connected to the paravertebral catheter

Interventions

paravertebral catheter placement

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

Intervention Type: PROCEDURE

0.2% ropivacaine

0.2% ropivacaine was infused through the elastomeric device

Intervention Type: DRUG

Elastomeric pump

An elastomeric pump was connected to the paravertebral catheter

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1309M42821

Identifier Type: -

Identifier Source: org_study_id