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

Study Overview
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Brief Summary
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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
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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 %.

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

Conditions
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Postoperative Pain, Postoperative Complications, Pancreatic Cancer, Haemodynamic Instability

Intervention / Treatment
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* Procedure: LOS
* Procedure: X-ray placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LOS group<br>Patients randomized to recieve epidural catheter placement with LOS technique, without any Rx control | Procedure: LOS<br>* placement of epidural catheters with LOS technique<br>|
| Experimental: X-ray group<br>Patients randomized for X-ray placement of epidural catheter | Procedure: X-ray placement<br>* placement of epidural catheters with x-ray guide<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural catheter, postoperative pain, LOS