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

PERiX: Comparison of Efficacy Between Placement of Epidural Catheters X-ray Guided and LOS Technique: Outcome Influence on Patient Underwent Pancreatic Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Complications; Postoperative Pain; Pancreatic Cancer; Haemodynamic Instability
• Intervention / Treatment: Procedure: LOS; Procedure: X-ray placement

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 %.

• Study Type: Interventional
• Enrollment (Anticipated): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alvise Martini, MD; Phone Number: 0458124666; Email: alvise.martini@univr.it

Study Locations

• Italy
  • Veneto
    • Verona, Veneto, Italy, 37126
      • Recruiting
      • Azienda ospedaliero-universitaria integrata Verona
      • Contact: Alvise Martini, MD; Phone Number: 0458124666; Email: alvise.martini@univr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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; placement of epidural catheters with LOS technique
Experimental: X-ray group; Patients randomized for X-ray placement of epidural catheter	Procedure: X-ray placement; placement of epidural catheters with x-ray guide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
• Investigators: Principal Investigator: Alvise Martini, MD, AOUI Verona

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): September 30, 2018
• Study Completion (Anticipated): September 30, 2019

Study Registration Dates

• First Submitted: June 27, 2018
• First Submitted That Met QC Criteria: September 25, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: September 25, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: postoperative pain; Epidural catheter; LOS
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Pain, Postoperative; Postoperative Complications
• Other Study ID Numbers: PERiX

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No