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OpenTrials
Completed

NCT Number: NCT02380417

Paravertebral Catheter for Lung Transplant

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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 The catheter was then fed 1 centimeter past the tip of the tuohy needle and needle was withdrawn.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paravertebral catheter placement

Procedure

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

0.2% ropivacaine

Drug

0.2% ropivacaine was infused through the elastomeric device

Elastomeric Pump

Device

An elastomeric pump was connected to the paravertebral catheter

Primary outcomes

  1. Maximal Pain score

    Time frame: each post catheter day from postoperative day 1 to day 7

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

Secondary outcomes

  1. Minimal Pain score

    Time frame: each post catheter day from post operative day 1 to day 7

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

  2. total opioid use

    Time frame: each post catheter day from postoperative day 1 to day 7

    opioids were normalized to milligrams of IV morphine

  3. length of stay

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

    participants followed for duration of stay expected average 3 weeks

  4. number of patients with nausea in the postoperative period

    Time frame: from day of surgery evaluated up to post catheter day 7

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 5, 2015
Registry last updated
Mar 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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