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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05548582
Other study ID # IRB00345074
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 12, 2023
Est. completion date December 31, 2024

Study information

Verified date June 2024
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 120
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
OxyCODONE 5 mg Oral Tablet
No opioid prescription after laparoscopic hysterectomy
Acetaminophen 500 mg Tab
Standard prescription
Ibuprofen 600 mg
Standard prescription

Locations

Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain score on post-operative day one Numeric pain score on post-operative day one: patient reported pain using the Likert pain scale from 0 to 10 1 day
Primary Pain score on post-operative day seven Numeric pain score on post-operative day seven: patient reported pain using the Likert pain scale from 0 to 10 7 days
Secondary Satisfaction of pain control on postoperative day one Overall satisfaction of pain control on postoperative day one (binary question - Yes/No) 1 day
Secondary Satisfaction of pain control on postoperative day seven Overall satisfaction of pain control on postoperative day seven (binary question - Yes/No) 7 days
Secondary Mobility on postoperative day one Satisfaction with mobility on postoperative day one (binary question - Yes/No) 1 day
Secondary Mobility on postoperative day seven Satisfaction with mobility on postoperative day seven (binary question - Yes/No) 7 days
Secondary Total opioid consumption on postoperative day one Total narcotic consumption by postoperative day one (in morphine milligram equivalent) 1 day
Secondary Total opioid consumption on postoperative day seven Total narcotic consumption by postoperative day seven (in morphine milligram equivalent) 7 days
Secondary Opioid related side effects on postoperative day one Presence of opioid related side effects such as nausea, vomiting, constipation, dizziness, abdominal distention, and itchiness on postoperative day one (binary question - Yes/No) 1 day
Secondary Opioid related side effects on postoperative day seven Presence of opioid related side effects such as nausea, vomiting, constipation, dizziness, abdominal distention, and itchiness on postoperative day seven (binary question - Yes/No) 7 days
Secondary Unplanned calls/visits Unplanned visits to the emergency room or clinic and unexpected patient initiated phone call related to pain control postoperatively (binary question - Yes/No) 7 days
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