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

Schneider, Marc Philipp; Löffel, Lukas M; Furrer, Marc; Burkhard, Fiona C.; Kleeb, Bettina; Curatolo, Michele; Wüthrich, Patrick Yves (2018). Can early oral prolonged-release oxycodone, with or without naloxone reduce the duration of epidural analgesia after cystectomy? A three-arm, randomized, double-blind, placebo-controlled trial. Pain, 159(3), pp. 560-567. Wolters Kluwer 10.1097/j.pain.0000000000001112

[img] Text
00006396-900000000-99098.pdf - Published Version
Restricted to registered users only
Available under License Publisher holds Copyright.

Download (516kB) | Request a copy
[img]
Preview
Text
accepted_manuscript_00006396-900000000-99098.pdf - Accepted Version
Available under License Publisher holds Copyright.

Download (1MB) | Preview

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, analgesics non-naïve patients. From postoperative day 3, patients received batches with oxycodone, oxycodone/naloxone or placebo every 12h (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 6h. 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 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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Dermatology, Urology, Rheumatology, Nephrology, Osteoporosis (DURN) > Clinic of Urology
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > DBMR Forschung Mu35 > Forschungsgruppe Urologie
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > DBMR Forschung Mu35 > Forschungsgruppe Urologie

04 Faculty of Medicine > Department of Intensive Care, Emergency Medicine and Anaesthesiology (DINA) > Clinic and Policlinic for Anaesthesiology and Pain Therapy

UniBE Contributor:

Schneider, Marc Philipp; Furrer, Marc; Burkhard, Fiona C.; Kleeb, Bettina and Wüthrich, Patrick Yves

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1872-6623

Publisher:

Wolters Kluwer

Language:

English

Submitter:

Jeannie Wurz

Date Deposited:

15 Dec 2017 08:42

Last Modified:

16 Feb 2018 01:31

Publisher DOI:

10.1097/j.pain.0000000000001112

PubMed ID:

29189517

BORIS DOI:

10.7892/boris.107623

URI:

https://boris.unibe.ch/id/eprint/107623

Actions (login required)

Edit item Edit item
Provide Feedback