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Can early oral prolonged-release oxycodone with or without naloxone reduce the duration of epidural analgesia after cystectomy? A 3-arm, randomized, double-blind, placebo-controlled trial

Schneider, Marc, P.a; Löffel, Lukas, M.b; Furrer, Marc, A.a; Burkhard, Fiona, C.a; Kleeb, Bettinab; Curatolo, Michelec; Wuethrich, Patrick, Y.b,*

doi: 10.1097/j.pain.0000000000001112
Clinical Note

Thoracic epidural analgesia (TEA) enhances recovery after bowel surgery. Early postoperative prolonged-release oral formulation of oxycodone or oxycodone/naloxone is potentially useful as a second analgesic step to reduce the duration of TEA. We hypothesized that oxycodone would decrease the duration of TEA and combined with naloxone preserve gastrointestinal function. Ninety patients undergoing open cystectomy and urinary diversion were enrolled in this randomized double-blind, three-arm, parallel-group, placebo-controlled single-center trial between September 2015 and February 2017. Exclusion criteria were known allergy to oxycodone/naloxone, pulmonary diseases, hepatopathy, and analgesics nonnaïve patients. From postoperative day 3, patients received batches with oxycodone, oxycodone/naloxone, or placebo every 12 hours (n = 30 in each arm). Reduction of the epidural drug infusion rate was attempted with the goal to maintain a pain intensity <3 at rest and <5 (numeric rating score) at mobilization during 6 hours. Primary endpoint was duration of TEA and secondary endpoint return of gastrointestinal function. The median duration of TEA did not differ between patients treated with oxycodone/naloxone (6.7 [range 3.1-10.3] days), oxycodone (7.0 [3.0-9.1]), or placebo (6.4 [3.1-8.4]); P = 0.88. Time to the first defecation was prolonged in the oxycodone group compared to the placebo group (difference 22.48 hours ±8.95; P = 0.037). In the oxycodone group, we found 8/30 patients with ileus (27%) compared to 2/28 (7%) in the oxycodone/naloxone group and to 2/30 (7%) in the placebo group; (P = 0.031). Oxycodone, with or without naloxone, did not reduce the duration of TEA. Oxycodone alone led to a delayed return of bowel function, whereas the combination was not different from placebo.

Neither early postoperative administration of prolonged-release oxycodone/naloxone nor oxycodone could reduce the duration of epidural analgesia after cystectomy and urinary diversion compared to placebo. Oxycodone prolonged time to first defecation.

aDepartment of Urology, University Hospital Bern, Bern, Switzerland

bDepartment of Anaesthesiology and Pain Medicine, University Hospital Inselspital Bern, Bern, Switzerland

cDepartment of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA

Corresponding author. Address: Department of Anesthesiology and Pain Therapy, University Hospital Bern, CH-3010 Berne, Switzerland. Tel.: +41316322483; fax: +41316320554. E-mail address: patrick.wuethrich@insel.ch (P.Y. Wuethrich).

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Received August 27, 2017

Received in revised form November 10, 2017

Accepted November 13, 2017

© 2018 International Association for the Study of Pain
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