Acute PainNCT02380417
Paravertebral Catheter for Lung Transplant
An observational study of Acute Pain, run by University of Minnesota.
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
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- 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 group | Role | What they receive |
|---|---|---|
| Single lung transplant paravertebral catheter placement | Those 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 placement | those 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.
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)
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
total opioid use
opioids were normalized to milligrams of IV morphine
Measured: each post catheter day from postoperative day 1 to day 7
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
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.
- First posted5 Mar 2015 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paravertebral Catheter Use for Postoperative Pain Control in Patients After Lung Transplant Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02380417
- Acronym / sponsor ID
- 1309M42821
- Conditions
- Acute Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single lung transplant paravertebral catheter placement | – | Procedure: paravertebral catheter placement, Drug: 0.2% ropivacaine, Device: Elastomeric pumpThose patients who underwent single lung transplant either right or left. |
| bilateral lung transplant paravertebral catheter placement | – | Procedure: paravertebral catheter placement, Drug: 0.2% ropivacaine, Device: Elastomeric pumpthose patients who underwent bilateral lung transplantation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who presented for a lung transplant and had a clamshell incision either single or bilateral.
Key inclusion criteria (3 listed)
- lung transplant
- clamshell incision
- received paravertebral catheter within 2 days of surgery
Key exclusion criteria (4 listed)
- non english speaking
- remained intubated for greater than 3 days postoperatively
- midline incision
- allergy to local anesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paravertebral catheter placementa thoracic paravertebral catheter was placed and connected to an elastomeric pump with a continuous infusion of 0.2% ropivacaine | Procedure or surgery | Single lung transplant paravertebral catheter placement, bilateral lung transplant paravertebral catheter placement |
| 0.2% ropivacaine0.2% ropivacaine was infused through the elastomeric device | Drug | Single lung transplant paravertebral catheter placement, bilateral lung transplant paravertebral catheter placement |
| Elastomeric pumpAn elastomeric pump was connected to the paravertebral catheter | Device | Single lung transplant paravertebral catheter placement, bilateral lung transplant paravertebral catheter placement |
Primary outcome
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
4 secondary outcomes
Minimal Pain score
Time frame: each post catheter day from post operative day 1 to day 7
total opioid use
Time frame: each post catheter day from postoperative day 1 to day 7
length of stay
Time frame: 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
Time frame: from day of surgery evaluated up to post catheter day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.