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PERiX: Comparison of Efficacy Between Placement of Epidural Catheters X-ray Guided and LOS Technique (PERiX)

Primary Purpose

Postoperative Pain, Postoperative Complications, Pancreatic Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
LOS
X-ray placement
Sponsored by
Azienda Ospedaliera Universitaria Integrata Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Pain focused on measuring Epidural catheter, postoperative pain, LOS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • scheduled for open pancreatic surgery
  • ASA < = 3

Exclusion Criteria:

  • scoliosis
  • coagulation abnormalities
  • antiplatelet drugs (except ASA)
  • history of back surgery
  • anticipated need of ICU stay

Sites / Locations

  • Azienda ospedaliero-universitaria integrata VeronaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

LOS group

X-ray group

Arm Description

Patients randomized to recieve epidural catheter placement with LOS technique, without any Rx control

Patients randomized for X-ray placement of epidural catheter

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
June 27, 2018
Last Updated
September 25, 2018
Sponsor
Azienda Ospedaliera Universitaria Integrata Verona
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1. Study Identification

Unique Protocol Identification Number
NCT03685370
Brief Title
PERiX: Comparison of Efficacy Between Placement of Epidural Catheters X-ray Guided and LOS Technique
Acronym
PERiX
Official Title
PERiX: Comparison of Efficacy Between Placement of Epidural Catheters X-ray Guided and LOS Technique: Outcome Influence on Patient Underwent Pancreatic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
September 30, 2018 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Universitaria Integrata Verona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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 %.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Postoperative Complications, Pancreatic Cancer, Haemodynamic Instability
Keywords
Epidural catheter, postoperative pain, LOS

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LOS group
Arm Type
Active Comparator
Arm Description
Patients randomized to recieve epidural catheter placement with LOS technique, without any Rx control
Arm Title
X-ray group
Arm Type
Experimental
Arm Description
Patients randomized for X-ray placement of epidural catheter
Intervention Type
Procedure
Intervention Name(s)
LOS
Intervention Description
placement of epidural catheters with LOS technique
Intervention Type
Procedure
Intervention Name(s)
X-ray placement
Intervention Description
placement of epidural catheters with x-ray guide
Primary Outcome Measure Information:
Title
Incidence of catheters malfunctions in LOS and X-ray group
Description
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.
Time Frame
every day until 7th postoperative day
Secondary Outcome Measure Information:
Title
Evaluate daily pain differences between groups: NRS (Numeric rating scale)
Description
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.
Time Frame
every day until 7th postoperative day
Title
Monitoring postoperative surgical complications between groups
Description
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
Time Frame
at 30th postoperative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: scheduled for open pancreatic surgery ASA < = 3 Exclusion Criteria: scoliosis coagulation abnormalities antiplatelet drugs (except ASA) history of back surgery anticipated need of ICU stay
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alvise Martini, MD
Phone
0458124666
Email
alvise.martini@univr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alvise Martini, MD
Organizational Affiliation
AOUI Verona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda ospedaliero-universitaria integrata Verona
City
Verona
State/Province
Veneto
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alvise Martini, MD
Phone
0458124666
Email
alvise.martini@univr.it

12. IPD Sharing Statement

Learn more about this trial

PERiX: Comparison of Efficacy Between Placement of Epidural Catheters X-ray Guided and LOS Technique

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