Opioid-Induced Bowel Dysfunction in Patients Undergoing Spine Surgery: Comparison of Oxycodone and Oxycodone-Naloxone Treatment

Abstract

IntroductionOpioids 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.MethodsA 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.ResultsAt 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.ConclusionIn 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. Trial registration: European Clinical Trials Database (EudraCT no. 2012-001816-42) and ClinicalTrials.gov database (Identifier: NCT02573922).

Bioavailability of oxycodone by mouth in coronary artery bypass surgery patients – a randomized trial

“…Moreover, it was found that oxycodone-naloxone tablets had a carry-over effect after seven days use of oxycodone two times a day; surveyed two weeks after opioid cessation, bowel function was superior after seven days of taking oxycodone-naloxone tablets compared to oxycodone tablets. 32 In the present study the opioid consumption and pain scores were similar or lower compared to our previous studies in similar settings. 4 , 29 , 30 Thus, it is unlikely that naloxone interfered with the analgesic efficacy of oxycodone.…”

Oral Prolonged‐Release Oxycodone/Naloxone for Managing Pain and Opioid‐Induced Constipation: A Review of the Evidence

“…Guidelines recommend a tailored approach for the management of postoperative pain, and short‐acting oral opioids are generally preferred over long‐acting oral opioids for the immediate postoperative period, due in part to dose titration requirements . Our literature search identified 8 studies investigating short‐term administration of OXN PR to manage pain following surgery, including RCTs, open‐label studies, and retrospective studies (see Table ) . Together, the finding suggested broadly comparable analgesia with OXN PR vs. OXY PR, morphine, or other opioid analgesics, and some but not all studies also documented additional improvements in bowel function and early functional outcomes with OXN PR .…”

“…Our literature search identified 8 studies investigating short‐term administration of OXN PR to manage pain following surgery, including RCTs, open‐label studies, and retrospective studies (see Table ) . Together, the finding suggested broadly comparable analgesia with OXN PR vs. OXY PR, morphine, or other opioid analgesics, and some but not all studies also documented additional improvements in bowel function and early functional outcomes with OXN PR . High patient satisfaction (72% “very satisfied”) with OXN PR plus oral ketoprofen was reported in a study of patients following hip replacement .…”

Updated Clinical Pharmacokinetics and Pharmacodynamics of Oxycodone

“…Evidence indicates that in selected patients, a CR oxycodone/naloxone tablet can be useful in reducing OIBD; positive effects on OIBD are seen after 7 days of use. Moreover, combining naloxone with oxycodone seems to have a carry-on effect on OIBD [106,107].…”