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Acute PainNCT02380417

Paravertebral Catheter for Lung Transplant

An observational study of Acute Pain, run by University of Minnesota.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Pain
What is being tested?
paravertebral catheter placement, 0.2% ropivacaine and Elastomeric pump
How many people
33 participants
Where
No sites listed yet
Study dates
Oct 2013to Dec 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

About this study

Official title: 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.

Read the 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
Being tested
paravertebral catheter placement, 0.2% ropivacaine, Elastomeric pump
Medical subject headings
Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • paravertebral catheter placementProcedure or surgery

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

  • 0.2% ropivacaineDrug

    0.2% ropivacaine was infused through the elastomeric device

  • Elastomeric pumpDevice

    An elastomeric pump was connected to the paravertebral catheter

Study groups in NCT02380417
Study groupRoleWhat they receive
Single lung transplant paravertebral catheter placementThose patients who underwent single lung transplant either right or left.
Receives: Procedure: paravertebral catheter placement; Drug: 0.2% ropivacaine; Device: Elastomeric pump
bilateral lung transplant paravertebral catheter placementthose patients who underwent bilateral lung transplantation
Receives: Procedure: paravertebral catheter placement; Drug: 0.2% ropivacaine; Device: Elastomeric pump

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal Pain score

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

    Measured: each post catheter day from postoperative day 1 to day 7

Secondary outcomes (4)
  1. Minimal Pain score

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

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

  2. total opioid use

    opioids were normalized to milligrams of IV morphine

    Measured: each post catheter day from postoperative day 1 to day 7

  3. length of stay

    participants followed for duration of stay expected average 3 weeks

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

  4. number of patients with nausea in the postoperative period

    Measured: from day of surgery evaluated up to post catheter day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2015 (estimated)
  2. Study startOct 2013
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02380417
Sponsor's protocol ID
1309M42821
Status last verified
Feb 2015
First submitted
2 Feb 2015
Last updated
5 Mar 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Pain, run by University of Minnesota.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal Pain score (time frame: each post catheter day from postoperative day 1 to day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.

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