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2017-03-01
2018-09-30
2019-09-30
154
NCT03685370
Azienda Ospedaliera Universitaria Integrata Verona
Azienda Ospedaliera Universitaria Integrata Verona
INTERVENTIONAL
PERiX: Comparison of Efficacy Between Placement of Epidural Catheters X-ray Guided and LOS Technique
The use of epidural catheters for postoperative analgesia in pancreatic surgery is recommended by the guidelines of the ERAS society. Some studies claim it may expose to hemodynamic alterations that may compromise outcome and increase postoperative complications, attributable to a malfunction of the catheter itself, often linked to a bad positioning, since this is usually positioned with LOS technique. Our hypothesis is that a positioning made using the radiographic guide the day before the intervention can significantly reduce the number of catheter's dysfunctions.
About 30% of epidural catheters are reported to have hypo or hyper functioning behaviour. This has and impact on postoperative pain control and can affect also surgical and global outcome since it is known that a malfunctional catheter carries an increased complication's rate. Our hypothesis is that rx-guided positioning can reduce the incidence of catheter malfunction afrom 30 to 15 %.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-06-27 | N/A | 2018-09-25 |
2018-09-25 | N/A | 2018-09-26 |
2018-09-26 | N/A | 2018-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Other
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: LOS group Patients randomized to recieve epidural catheter placement with LOS technique, without any Rx control | PROCEDURE: LOS
|
| EXPERIMENTAL: X-ray group Patients randomized for X-ray placement of epidural catheter | PROCEDURE: X-ray placement
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incidence of catheters malfunctions in LOS and X-ray group | malfunctional catheters are defined as following: * symptomatic hypotension due to epidural infusion * NRS > 6 in the first postoperative day and NRS > 4 in subsequent postoperative day * overt malpositioning: * rx evidence of catheter's tip under T10 during routine rx or TC * NRS > 6 (due to pain at T7-10 dermatomers) with 5 cc/h catheter infusion and response to lidocaine 1% 6ml bolus (low tip) * NRS > 6 (due to pain at T7-10 dermatomers) with 5 cc/h catheter infusion and NO response to lidocaine 1% 6ml bolus ( not in epidural space or very low tip) * evidence of catheter accidental removal Numerical Rating Scale (NRS) is used to assess pain. Patients self-report actual pain on 0 to 10 scale where 0 is no pain and 10 is the worst immaginable pain. | every day until 7th postoperative day |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Evaluate daily pain differences between groups: NRS (Numeric rating scale) | Parameter used -higher postoperative daily numeric rating scale (NRS) until catheter removal Numerical Rating Scale (NRS) is used to assess pain. Patients self-report actual pain on 0 to 10 scale where 0 is no pain and 10 is the worst immaginable pain. | every day until 7th postoperative day |
| Monitoring postoperative surgical complications between groups | Complications are considered as: * bleedings * infections * pancreatic fistulas (degree) * biliary fistulas * abdominal collections * ICU admission * needs of new surgery (for any reasons) * pneumonia * delayed gastric emptying | at 30th postoperative day |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Alvise Martini, MD Phone Number: 0458124666 Email: alvise.martini@univr.it |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
