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

Not Applicable

• Conditions: Postoperative Pain; Postoperative Complications; Pancreatic Cancer; Haemodynamic Instability
• Interventions: Procedure: X-ray placement; Procedure: LOS

• Registration Number: NCT03685370
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

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 %.

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2018-06-27
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-25
• Last Update Submitted: 2018-09-25
• Study First Posted: 2018-09-26
• Last Update Posted: 2018-09-26
• Primary Completion: 2018-09-30
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 154

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
X-ray group	X-ray placement	Patients randomized for X-ray placement of epidural catheter
LOS group	LOS	Patients randomized to recieve epidural catheter placement with LOS technique, without any Rx control

Primary Outcome Measures

Name	Time	Method
Incidence of catheters malfunctions in LOS and X-ray group	every day until 7th postoperative day	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

Name	Time	Method
Evaluate daily pain differences between groups: NRS (Numeric rating scale)	every day until 7th postoperative day	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	at 30th postoperative day	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

Trial Locations

Locations (1)

Azienda ospedaliero-universitaria integrata Verona; 🇮🇹 Verona, Veneto, Italy