Dataset Information

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

ABSTRACT:

Introduction

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.

Methods

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.

Results

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.

Conclusion

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.

Trial registration

European Clinical Trials Database (EudraCT no. 2012-001816-42) and ClinicalTrials.gov database (Identifier: NCT02573922).

SUBMITTER: Kokki M

PROVIDER: S-EPMC5216064 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:The use of opioids in the treatment of chronic pain is widespread; the prevalence of specific opioids varies from country to country and depends on product availability, national formulary systems, and provider preferences. Patients often receive opioids for legitimate treatment of pain conditions, but on the opposite side of the spectrum, nonmedical use of opioids is a significant public health concern. Opioids are associated with several side effects, and constipation is the most commonly reported and persistent symptom. Unlike some adverse effects associated with opioid use, tolerance does not develop to constipation. Opioid-induced constipation (OIC) is the most prevalent patient complaint associated with opioid use and has been associated with declines in various quality of life measures. OIC can be extremely difficult for patients to tolerate and may prompt patients to decrease or discontinue opioid treatment. Current management strategies for OIC are often insufficient. A prolonged-release formulation of oxycodone/naloxone (OXN) has been investigated for the treatment of nonmalignant and cancer pain and mitigation of OIC, and evidence is largely favorable. Studies have demonstrated the capability of OXN to alleviate OIC while maintaining pain control comparable to oxycodone-only regimens. There is insufficient evidence for OXN efficacy for patients with mild OIC or patients maintained on high doses of opioids, and use in these populations is controversial. The reduction of costs associated with OIC may provide overall cost effectiveness with OXN. Additionally, the presence of naloxone may deter abuse/misuse by those seeking to misuse the formulation by modes of administration other than oral ingestion. Most studies to date have occurred in European countries, and phase 3 trials continue in the United States. This review will include current therapeutic options for pain and constipation, unique characteristics of OXN, evidence related to use of OXN and its place in therapy, discussion of opioid abuse/misuse, and various abuse-deterrent mechanisms, and areas of continuing research.

Project description:Study designRetrospective administrative database review.ObjectiveAnalyze patterns of opioid use in patients undergoing lumbar surgery and determine associated risk factors in a Medicaid population.Summary of background dataOpioid use in patients undergoing surgery for degenerative lumbar spine conditions is prevalent and impacts outcomes. There is limited information defining the scope of this problem in Medicaid patients.Materials and methodsLongitudinal cohort study of adult South Carolina (SC) Medicaid patients undergoing lumbar surgery from 2014 to 2017. All patients had continuous SC Medicaid coverage for 15 consecutive months, including six months before and nine months following surgery. The primary outcome was a longitudinal assessment of postoperative opioid use to determine trajectories and group-based membership using latent modeling. Univariate and multivariable modeling was conducted to assess risk factors for group-based trajectory modeling and chronic opioid use (COU).ResultsA total of 1455 surgeries met inclusion criteria. Group-based trajectory model demonstrated patients fit into five groups; very low use (23.4%), rapid wean following surgery (18.8%), increasing use following surgery (12.9%), slow wean following surgery (12.6%) and sustained high use (32.2%). Variables predicting membership in high opioid use included preoperative opioid use, younger age, longer length of stay, concomitant medications, and readmissions. More than three quarter of patients were deemed COUs (76.4%). On bivariate analysis, patients with degenerative disk disease were more likely to be COUs (24.8% vs. 18.6%; P =0.0168), more likely to take opioids before surgery (88.5% vs. 61.9%; P <0.001) and received higher amounts of opioids during the 30 days following surgery (mean morphine milligram equivalents 59.6 vs. 25.1; P <0.001).ConclusionsMost SC Medicaid patients undergoing lumbar elective lumbar spine surgery were using opioids preoperatively and continued long-term use postoperatively at a higher rate than previously reported databases. Preoperative and perioperative intake, degenerative disk disease, multiple prescribers, depression, and concomitant medications were significant risk factors.

Project description:ImportanceProlonged prescribing of opioids after spine surgery is often perceived as a negative outcome, but successful opioid reduction may occur despite continued prescribing. Improved characterization of opioid availability before and after surgery is necessary to identify these successes.ObjectiveTo evaluate the association between spine surgery and modification of opioid availability postoperatively by using consistent definitions to classify opioid availability before and after surgery.Design, setting, and participantsThis population-based cohort study included 2223 adults (age ≥18 years) who underwent spine surgery in Olmsted County, Minnesota, from January 1, 2005, through December 31, 2016. Data were analyzed from April 1, 2019, to December 1, 2019.ExposuresPreoperative opioid availability based on prescription data in the 180 days before surgery in accordance with Consortium to Study Opioid Risks and Trends (CONSORT) definitions.Main outcomes and measuresSuccessful modification of opioid availability, defined as an improvement in CONSORT status postoperatively (assessed from 181 to 365 days after surgery) compared with preoperative status, or continued absence of opioid availability for patients with no preoperative availability. Multivariable logistic regression was used to assess the association between preoperative opioid availability and successful modification by 1 year after undergoing surgery.ResultsOf 2223 patients included in the study, 1214 were male (54.6%), with a median age of 55 years (interquartile range, 43-68) years. Patients were classified as having no (778 [35.0%]), short-term (1118 [50.3%]), episodic (227 [10.2%]), or long-term (100 [4.5%]) preoperative opioid availability. Of the 2148 patients (96.6%) who were alive at 1 year, postoperative opioid availability was classified as no (1583 [73.7%]), short-term (398 [18.5%]), episodic (104 [4.8%]), and long-term (63 [2.9%]). A total of 1672 patients (77.8%) had successful modification of opioid availability, with success of 83.0% for those with no preoperative availability, 74.9% for those with short-term preoperative availability, 79.8% for those with episodic preoperative availability, and 64.4% for those with long-term preoperative opioid availability. In multivariable analysis, success was significantly associated with preoperative opioid availability (odds ratio [OR] for short term, 0.61 [95% CI, 0.48-0.77]; OR for episodic, 0.95 [95% CI, 0.64-1.40]; OR long term, 0.49 [95% CI, 0.30-0.82]; P < .001 overall vs no availability).Conclusions and relevanceIn this study, when following standardized CONSORT definitions, 4 of 5 adults undergoing spine surgery in a population-based cohort met the criteria for a successful pattern of postoperative opioid prescribing. Similar methods to objectively assess changes in opioid prescribing may be clinically useful in other perioperative settings.