Trial reportAdvances in therapy2017
Opioid-Induced Bowel Dysfunction in Patients Undergoing Spine Surgery: Comparison of Oxycodone and Oxycodone-Naloxone Treatment.
Trial report in Advances in therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02573922 (Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery), which is not on this map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery
Who cites it
5 citing papers in PubMed, 17 citations in OpenAlex.
- Life satisfaction and pain interference in spine surgery patients before and after surgery: comparison between on-opioid and opioid-naïve patients.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2018Trial
- The Routes of Administration for Acute Postoperative Pain Medication.Pain and therapy · 2021Review
- Bioavailability of oxycodone by mouth in coronary artery bypass surgery patients - a randomized trial.Journal of drug assessment · 2020Article
- Updated Clinical Pharmacokinetics and Pharmacodynamics of Oxycodone.Clinical pharmacokinetics · 2019Review
- The Basic Pharmacology of Opioids Informs the Opioid Discourse about Misuse and Abuse: A Review.Pain and therapy · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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 registrationEuropean Clinical Trials Database (EudraCT no. 2012-001816-42) and ClinicalTrials.gov database (Identifier: NCT02573922).
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