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

Pancreatic Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03685370
• Other study ID #: PERiX
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: September 2018
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: Alvise Martini, MD
• Phone: 0458124666
• Email: alvise.martini[@]univr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 %.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Haemodynamic Instability
• Pain, Postoperative
• Pancreatic Cancer
• Pancreatic Neoplasms
• Postoperative Complications
• Postoperative Pain

Intervention

Procedure:
• LOS
placement of epidural catheters with LOS technique
• X-ray placement
placement of epidural catheters with x-ray guide

Locations

Country	Name	City	State
Italy	Azienda ospedaliero-universitaria integrata Verona	Verona	Veneto

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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