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

Integrated University Hospital Trust of Verona

Status: Unknown

Conditions: Postoperative Complications; Postoperative Pain; Haemodynamic Instability; Pancreatic Cancer

Treatments: Procedure: LOS; Procedure: X-ray placement

Study type: Interventional

Funder types: Other

Identifiers

NCT03685370

PERiX

Details and patient eligibility

About

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.

Full 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 %.

Enrollment: 154 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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154 participants in 2 patient groups

LOS group

Active Comparator group

Description:

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

Treatment:

Procedure: LOS

X-ray group

Experimental group

Description:

Patients randomized for X-ray placement of epidural catheter

Treatment:

Procedure: X-ray placement