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

NCT03685370 | Unknown

• 1 other identifier: PERiX
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Postoperative Complications; Pancreatic Cancer; Haemodynamic Instability

Keywords

Epidural catheter; postoperative pain; LOS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluate daily pain differences between groups: NRS (Numeric rating scale)

  every day until 7th postoperative day

• Monitoring postoperative surgical complications between groups

  at 30th postoperative day

Study Arms (2)

LOS group

ACTIVE COMPARATOR

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

Procedure: LOS

X-ray group

EXPERIMENTAL

Patients randomized for X-ray placement of epidural catheter

Procedure: X-ray placement

Interventions

LOS PROCEDURE

placement of epidural catheters with LOS technique

LOS group

X-ray placement PROCEDURE

placement of epidural catheters with x-ray guide

X-ray group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled for open pancreatic surgery
• ASA \< = 3

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

Azienda ospedaliero-universitaria integrata Verona

Verona, Veneto, 37126, Italy

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Complications; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Alvise Martini, MD

  AOUI Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alvise Martini, MD

CONTACT

0458124666; alvise.martini@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: September 26, 2018
• Study Start: March 1, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2019
• Last Updated: September 26, 2018

Record last verified: 2018-09

Locations

IT (1)