Early Postoperative Administration of Oxycodone +/- Naloxone and Duration of Epidural Analgesia
Status:
Completed
Trial end date:
2017-02-28
Target enrollment:
Participant gender:
Summary
Cystectomy with urinary diversion (ileal conduit, ileal orthotopic neobladder, catheterizable
ileal pouch) is major abdominal surgery, which is associated with a high incidence of
gastrointestinal complications.Perioperative techniques aiming at an early return of bowel
function are to be pursued.
Optimal postoperative pain management is one of the key factors leading to enhanced recovery
after surgery. The perioperative use of an epidural analgesia for major abdominal surgery is
established, not only because of its excellent analgesic properties, but also because it can
accelerate the return of bowel function. However, epidural analgesia is associated with
additional costs, need for close monitoring and nursing. In addition each supplemental day
with an indwelling epidural catheter increases the risk of infection. So it is recommended to
re-assess the risk/benefit ratio of an epidural analgesia after 4 days, if not sooner.
Therefore, it is important to develop strategies that reduce its duration without impairing
the benefits. Systemic analgesics with prolonged-release oral formulation like oral oxycodone
(Oxycontin®) or combined drug mixture (oral oxycodone/naloxone (Targin®)) could be a valuable
alternative pain treatment as a second analgesic step, starting on postoperative day (POD) 3,
so that the epidural catheter could be removed earlier without impairing postoperative
enhanced recovery including return of the bowel function. Both oxycodone and naloxone orally
administered are a recognized and accepted treatment option.
The objective of this study is to evaluate the implementation of an oral opioid with or
without naloxone in the early postoperative period in patients undergoing open radical
cystectomy with urinary diversion and intraoperative and early postoperative use of epidural
analgesia. The investigators expect an unchanged early return of the bowel function and equal
analgesia with a reduced length of stay of the epidural catheter (primary endpoint), thus
potentially reducing epidural catheter associated complications and lowering costs (nursing
and pain service).