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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.
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 %.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LOS group | Active Comparator | Patients randomized to recieve epidural catheter placement with LOS technique, without any Rx control |
|
| X-ray group | Experimental | Patients randomized for X-ray placement of epidural catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LOS | Procedure | placement of epidural catheters with LOS technique |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of catheters malfunctions in LOS and X-ray group | malfunctional catheters are defined as following:
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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alvise Martini, MD | Contact | 0458124666 | alvise.martini@univr.it |
| Name | Affiliation | Role |
|---|---|---|
| Alvise Martini, MD | AOUI Verona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda ospedaliero-universitaria integrata Verona | Recruiting | Verona | Veneto | 37126 | Italy |
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| X-ray placement |
| Procedure |
placement of epidural catheters with x-ray guide |
|
| Monitoring postoperative surgical complications between groups | Complications are considered as:
| at 30th postoperative day |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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