A Randomized Controlled Trial to Study the Effects of One-time Intra-operative Dosing of Methadone During Laparoscopic or Robotic Hysterectomy in Reducing Opioid Prescription.
Johns Hopkins University
Summary
Currently, there is a nationwide epidemic of opioid abuse and overdose deaths. One source of excess opioids is overprescribing in the postoperative period. This study aims to find the optimal pain medication plan during and after laparoscopic hysterectomy to eliminate long-term opioid use. Given the increasing opioid abuse and over-prescription post-operatively, an effort should be made to determine whether one time dosing of Methadone, a longer opioid analgesics, intra-operatively is an adequate potential in treating postoperative pain after hysterectomy surgeries. The investigators hypothesize that this could minimize the need for additional post-operative and outpatient opioid prescriptions and decrease the adverse effects that are associated with the consumption, including new opioid abuse. Intervention group will receive methadone intraoperatively while the other group would receive short-acting opioids (standard).
Description
Problem: The relief of moderate to severe postoperative pain in surgeries including abdominal surgeries continues to pose a major therapeutic dilemma. The traditional and most common therapy is the administration of short-acting opioid analgesics, intra-operative and post-operative, at intervals every 3-4 hours. However, the use of opioids with relatively short plasma half-lives at varying intervals may lead to various fluctuating drug concentrations in plasma, and side effects including respiratory, longer hospitalizations, delayed ambulation, inadequate pain relief and potential avenues for…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Individuals with a uterus * Age 18 years old and above * Undergoing minimally invasive (laparoscopic or robotic) hysterectomy with ovarian preservation * Benign indications for hysterectomy * Agreeing to participate Exclusion Criteria: * Chronic pain syndromes patients including fibromyalgia * Patients currently on long-term (i.e. for more than three months) opioid use * Patients currently on agonist-antagonist medications (e.g. buprenorphine) * Patients taking a selective serotonin reuptake inhibitor or monoamine oxidase inhibitor * Conversion to laparotomy * Allergy…
Interventions
- DrugMethadone
Intra-operative single dose IV Methadone (0.25 mg/kg of ideal body weight)
Locations (2)
- The Johns Hopkins Bayview Medical CenterBaltimore, Maryland
- The Johns Hopkins HospitalBaltimore, Maryland