Pain, Postoperative, Opioid Misuse, Opioid Use, Pain
Conditions
Brief summary
Given the nationwide epidemic of opioid use and abuse (in part due to over prescription), this study aims at addressing the need for opioid prescription after laparoscopic hysterectomy.
Detailed description
Currently, there is a nationwide epidemic of opioid abuse and overdose deaths. One source of excess opioids is overprescribing in the postoperative period. Given the increasing opioid abuse and over-prescription post-operatively, an effort must be made to determine whether non-opioid multimodal medications are adequate in treating postoperative pain after laparoscopic hysterectomy and would not increase the need for additional prescriptions or unscheduled patient contacts. This study aims to find the optimal prescriptions for pain after laparoscopic hysterectomy in an attempt to eliminate opioid use.
Interventions
DRUGAcetaminophen 500 mg Tab
Standard prescription
No opioid prescription after laparoscopic hysterectomy
DRUGIbuprofen 600 mg
Standard prescription
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients over the age of 18 undergoing outpatient laparoscopic (conventional or robotic) hysterectomy for benign indications
Exclusion criteria
* Allergy or other contraindication to the prescribed medications such as acetaminophen, ibuprofen, or oxycodone * Known opioid use or abuse (defined as reported use or treatment for abuse within the last 3 months) * Chronic pain patients * Conversion to laparotomy * Malignancy as the indication for surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score on post-operative day one | 1 day | Numeric pain score on post-operative day one: patient reported pain using the Likert pain scale from 0 to 10 |
| Pain score on post-operative day seven | 7 days | Numeric pain score on post-operative day seven: patient reported pain using the Likert pain scale from 0 to 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mobility on postoperative day one | 1 day | Satisfaction with mobility on postoperative day one (binary question - Yes/No) |
| Mobility on postoperative day seven | 7 days | Satisfaction with mobility on postoperative day seven (binary question - Yes/No) |
| Total opioid consumption on postoperative day one | 1 day | Total narcotic consumption by postoperative day one (in morphine milligram equivalent) |
| Satisfaction of pain control on postoperative day one | 1 day | Overall satisfaction of pain control on postoperative day one (binary question - Yes/No) |
| Opioid related side effects on postoperative day one | 1 day | Presence of opioid related side effects such as nausea, vomiting, constipation, dizziness, abdominal distention, and itchiness on postoperative day one (binary question - Yes/No) |
| Opioid related side effects on postoperative day seven | 7 days | Presence of opioid related side effects such as nausea, vomiting, constipation, dizziness, abdominal distention, and itchiness on postoperative day seven (binary question - Yes/No) |
| Unplanned calls/visits | 7 days | Unplanned visits to the emergency room or clinic and unexpected patient initiated phone call related to pain control postoperatively (binary question - Yes/No) |
| Total opioid consumption on postoperative day seven | 7 days | Total narcotic consumption by postoperative day seven (in morphine milligram equivalent) |
| Satisfaction of pain control on postoperative day seven | 7 days | Overall satisfaction of pain control on postoperative day seven (binary question - Yes/No) |
Countries
United States
Outcome results
None listed