Design and feasibility of a double-blind, randomized trial of peri-operative methylnaltrexone for postoperative ileus prevention after adult spinal arthrodesis
| Autor: | H. Francis Farhadi, Daniel Vazquez, Tristan Weaver, Shelby D. Miracle, Connor S. Gifford, Benjamin G. McGahan, Amy J. Minnema, Claire V. Murphy |
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| Rok vydání: | 2022 |
| Předmět: |
Adult
Male Population Arthrodesis Placebo law.invention Ileus Postoperative Complications Randomized controlled trial law Humans Medicine Pharmacology (medical) education Retrospective Studies education.field_of_study business.industry Incidence (epidemiology) General Medicine Perioperative Methylnaltrexone Institutional review board Naltrexone Quaternary Ammonium Compounds Anesthesia Feasibility Studies Complication business medicine.drug |
| Zdroj: | Contemporary Clinical Trials. 112:106623 |
| ISSN: | 1551-7144 |
| Popis: | Background Postoperative ileus (POI) is a common complication with no proven prophylactic measures in place. While perioperative opioid use has been implicated in POI development, current treatments fail to target this disease mechanism. Methylnaltrexone (MNTX) has been used to prevent the effects of opioids on the bowel and could reduce the incidence of POI when administered preoperatively. Methods In this phase IIb randomized controlled trial, we assessed the effect of perioperative MNTX on time-to-first-bowel movement following spinal arthrodesis surgeries. Results 82 patients were randomly selected in a 1:1 ratio to be included in either the treatment or placebo groups. Comparison of relevant factors of included patients to patients who refused to participate (n = 21) and to a prior retrospective series (n = 241) revealed no differences in age, male sex, liver disease, and number of surgical levels. Overall treatment fidelity (98% adherence) and retention (100% at one-month follow-up) were high. The predicted POI incidence (9.3–11.1%) was also equivalent to a prior retrospective series. However, the overall observed POI incidence (3.7%) was lower than expected, which could reflect a superimposed ‘trial effect’ related to standardized care in a research setting. Conclusions Since exposure to significant opioid doses represents a barrier to enhanced recovery after surgery, the results of this innovative trial may provide further guidance for the peri-operative use of opioid-receptor blockers. Here, we show that MNTX can be effectively administered in the peri-operative period with appropriate follow-up achieved in a representative population of patients undergoing spinal surgery. Trial registration numbers Clinicaltrials.gov – NCT03852524 and Institutional Review Board – 2018H0260. |
| Databáze: | OpenAIRE |
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