Haemodynamic Instability, Pancreatic Cancer, Postoperative Complications, Postoperative Pain
Conditions
Keywords
Epidural catheter, postoperative pain, LOS
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 %.
Interventions
PROCEDURELOS
placement of epidural catheters with LOS technique
PROCEDUREX-ray placement
placement of epidural catheters with x-ray guide
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Contacts
Primary ContactAlvise Martini, MD
Outcome results
None listed