Early Postoperative Administration of Oxycodone +/- Naloxone and Duration of Epidural Analgesia

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).

Conditions

• Postoperative Pain Management
• Radical Cystectomy
• Epidural Analgesia
• Oral Oxycodone With/Without Naloxone
• Return of the Bowel Function

Interventions

DRUG

oxycodone/naloxone

Oxycodone and naloxone (Targin®; Mundipharma Medical Company and Mundipharma Research GmbH \& Co Basel, Switzerland): Will be orally administered at 12 hours intervals, starting with 10mg/5mg on POD 3 and move to 20mg/10mg the other day.

DRUG

Oxycodone

Oxycodone (Oxycontin®, Mundipharma Medical Company and Mundipharma Research GmbH \& Co Basel, Switzerland): Will be orally administered at 12 hours intervals, starting with 10 mg on POD 3 and move to 20 mg the other day.

DRUG

Placebo

Placebo (Mundipharma Medical Company and Mundipharma Research GmbH \& Co Basel, Switzerland): Will be orally administered at 12 hours intervals starting on POD 3.

DEVICE

epidural catheter

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern

  lead OTHER

Principal Investigators

• Patrick Y Wuethrich, MD · Department of Anaesthesiology and Pain Therapy, University Hospital Bern

• Fiona C Burkhard, MD · Department of Urology, University Hospital Bern

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-09-14

Primary Completion

2017-02-20

Completion

2017-02-28

Countries

• Switzerland

Study Locations