New Silver or ancient gold? The new OnQ Silver soaker catheter versus the thoracic Epidural, the ancient goLden standard in ERAS ColorecTal surgery: a prospective superiority cohort study

Colorectal cancer is still the world*s leading cause of death. To offer
patients a smooth planning and performance of their surgery is one mayor goal,
that the Wilhelmina Hospital achieves. An even more important point is: to
create the possibility for all patients to start their postoperative adjuvant
treatment as soon as possible after surgery. To reach this goal it is necessary
to discharge the patients at the earliest possible after surgery, in the best
possible condition.
Optimal recovery after colorectal surgery is also the main goal of all ERAS
(early recovery after surgery) guidelines.

The actual ERAS statement regarding intra- and postoperative analgesia
recommends to not use thoracic epidural catheters in laparoscopic surgery
anymore as a gold standard. After years of glorification of this technique it
seems to be classified as over-treatment nowadays and needs to be replaced by
other techniques fitting the minimized surgical trauma.
Unfortunately the ERAS society does not give clear advice to date how to
replace a good working epidural catheter within a multimodal anesthetic
regimen.

There is evidence however that abdominal wall blocks, such as TAP blocks, could
help managing the postoperative pain, but covering the visceral pain is not
possible with this technique. It is not even clear to date which component of
pain, the abdominal wall pain or the viscero-sensoric pain, play the mayor role
postoperatively. It just seems logically, that only treating one part may not
be sufficient and may lead to a higher opioid consumption.
To not take any advantage of the modern peripheral nerve or compartment block
techniques would mean to step back to general anesthesia alone.
Since there is enough evidence that opioid based general anesthesia, followed
by an opioid containing postoperative analgesic scheme is not state of the art
in cancer treatment, this study will investigate an alternative possibility of
pain therapy: delivering local anesthetic via a multi hole catheter to both
sites of most surgical trauma - intraabdominal as-well as preperitoneal.
The catheters cannot be placed preoperatively hence the possibility of
preemptive analgesia is simply not existing. To make sure that the comparison
with an already preoperative working epidural catheter makes sense, the
patients in the investigational group will receive an infusion of Lidocaine
started with induction of general anesthesia.
Taking into account the result of a study on laparoscopic surgery in gynecology
we expect to see comparable little opioid use postoperatively, faster recovery
with mobilization soon after surgery and a shorter length of stay in the
interventional group.

The study will be designed as a prospective cohort study. We will include 22
patients per cohort.
The control group (cohort 1) will receive the standard treatment regimen with a
thoracic epidural catheter (Ropivacaine 0,2% and Sufentanil 1mcg/ml). Depending
on the type of surgery the epidural catheter will be used until POD 2
(hemicolectomy) or POD 3 (low anterior rectum resection). This resembles the
hospital*s standard procedure.
The treatment group (cohort 2) will receive and intravenous Lidocaine 1% during
the surgical procedure. At the end of surgery the surgeon will place two OnQ
silver soaker multi hole catheters.
Both groups will receive a standardized general anesthesia and postoperative
analgesics.

see study design

Patients in cohort 1 do ondergoed the standard rises of an thoracic epidural
catheter. This is a wel known, decennia old technique and resembles the golden
standard, Hence this technique is not under investigation here and so the
possible risks are no part of this study.
Patients in cohort 2 undergo the risk of an transcutaneous katheter placement
like bleeding, local infection and katheter displacement.
In comparison to the much more invasive epidural the risks are seen as mild to
moderate. The benefits like better mobility and shorter length of stay which
make an adjuvant therapy possible much sooner, outweigh those risks by far.