title: Opioid-Induced Bowel Dysfunction in Patients Undergoing Spine Surgery: Comparison of Oxycodone and Oxycodone-Naloxone Treatment.
abstract: Opioids are needed for postoperative pain in spine surgery patients, but opioid-induced constipation is a harmful adverse event. The aim of this clinical trial was to compare the use of a controlled-release oxycodone-naloxone combination product with oxycodone controlled-release tablets in these patients. The main outcome measure was the prevalence of constipation at 7 days postoperatively assessed with a Bowel Function Index questionnaire. A follow-up assessment at 21 days after surgery was also included.
  
  
  
  A total of 180 patients undergoing spine surgery, 91 having preoperative opioids in use and 89 opioid-naïve, were randomized to receive twice-daily oxycodone 10 mg or oxycodone-naloxone 10/5 mg controlled-release tablets for the first 7 postoperative days. Patients were followed-up for 21 days after surgery.
  
  
  
  At baseline, prevalence of constipation was common both in the opioid-naïve-25/87 (29%) and on-opioid groups 43/90 (48%) (P = 0.009). This increased at 7 days postoperatively with no difference between the groups, 54/89 with oxycodone and 54/88 with oxycodone-naloxone had constipation. At 21 days, constipation was less than in the baseline in both groups, in the opioid-naïve group the prevalence of constipation was 3/43 (7%) in patients with oxycodone-naloxone compared to 9/44 (21%) with oxycodone (effect size 0.68; P = 0.068). Both study compounds provided similar pain relief and were well tolerated.
  
  
  
  In patients presented for back surgery, the prevalence of constipation was significantly higher than that in the community. In opioid-naïve subjects, oxycodone-naloxone was beneficial concerning constipation; but this was not distinguishable in subjects with chronic opioid use. The analgesic efficacy of oxycodone and oxycodone-naloxone was similar.
  
  
  
  European Clinical Trials Database (EudraCT no. 2012-001816-42) and ClinicalTrials.gov database (Identifier: NCT02573922).
authors.affiliation: Department of Anaesthesia and Operative Services, Kuopio University Hospital, Kuopio, Finland. hannu.kokki@uef.fi.|Faculty of Health Sciences, School of Medicine, University of Eastern Finland, Kuopio, Finland. hannu.kokki@uef.fi.
authors.forename: Merja
authors.initials: M
authors.lastname: Kokki
authors.affiliation: Department of Anaesthesia and Operative Services, Kuopio University Hospital, Kuopio, Finland.|Faculty of Health Sciences, School of Medicine, University of Eastern Finland, Kuopio, Finland.
authors.forename: Moona
authors.initials: M
authors.lastname: Kuronen
authors.affiliation: Hospital Pharmacy, Kuopio University Hospital, Kuopio, Finland.
authors.forename: Toivo
authors.initials: T
authors.lastname: Naaranlahti
authors.affiliation: Department of Orthopaedics, Kuopio University Hospital, Kuopio, Finland.
authors.forename: Timo
authors.initials: T
authors.lastname: Nyyssönen
authors.affiliation: Department of Anaesthesia and Operative Services, Kuopio University Hospital, Kuopio, Finland.|Faculty of Health Sciences, School of Medicine, University of Eastern Finland, Kuopio, Finland.
authors.forename: Ira
authors.initials: I
authors.lastname: Pikkarainen
authors.affiliation: Department of Neurosurgery, Neuro Centre, Kuopio University Hospital, Kuopio, Finland.
authors.forename: Sakari
authors.initials: S
authors.lastname: Savolainen
authors.affiliation: Department of Anaesthesia and Operative Services, Kuopio University Hospital, Kuopio, Finland.|Faculty of Health Sciences, School of Medicine, University of Eastern Finland, Kuopio, Finland.
authors.forename: Hannu
authors.initials: H
authors.lastname: Kokki
mesh_terms: D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003248:Constipation / Q000139:chemically induced* / Q000517:prevention & control*; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009270:Naloxone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019635:Neurosurgical Procedures / Q000009:adverse effects; D017063:Outcome Assessment, Health Care; D010098:Oxycodone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010149:Postoperative Pain / Q000188:drug therapy*; D011446:Prospective Studies; D016037:Single-Blind Method; D011795:Surveys and Questionnaires
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D004338:Drug Combinations; C557247:oxycodone naloxone combination; D009270:Naloxone; D010098:Oxycodone
keywords: Constipation; Opioid induced bowel dysfunction (OIC); Oxycodone; Oxycodone-naloxone; Spine surgery