Pain, PostoperativeNCT05548582
Reduced Opioid Prescription After Laparoscopic Hysterectomy
A study testing OxyCODONE 5 mg Oral Tablet, Acetaminophen 500 mg Tab and Ibuprofen 600 mg in people with Pain, Postoperative and Opioid Misuse, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Opioid Misuse, Opioid Use
- What is being tested?
- OxyCODONE 5 mg Oral Tablet, Acetaminophen 500 mg Tab and Ibuprofen 600 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over the age of 18 undergoing outpatient laparoscopic (conventional or robotic) hysterectomy for benign indications
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Study Reduced Opioid Prescription After Laparoscopic Hysterectomy
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.
Read the 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.
- Conditions
- Pain, Postoperative, Opioid Misuse, Opioid Use, Pain
- Being tested
- OxyCODONE 5 mg Oral Tablet, Acetaminophen 500 mg Tab, Ibuprofen 600 mg
- Medical subject headings
- Pain, Postoperative, Opioid-Related Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxyCODONE 5 mg Oral TabletDrug
No opioid prescription after laparoscopic hysterectomy
Acetaminophen 500 mg TabDrug
Standard prescription
Ibuprofen 600 mgDrug
Standard prescription
| Study group | Role | What they receive |
|---|---|---|
| Post-operative opioid prescription | Other | Ibuprofen 600mg every 6 hours x 48 hours then as needed (total 30 tablets). If allergy or contraindication to ibuprofen, then will receive Meloxicam 15mg daily x 48 hours then as needed
Acetaminophen 500mg every 6 hours x 48 hours then as needed (total 30 tablets)
Oxycodone 5mg every 4 hours as needed (total 12 tablets) Receives: Drug: OxyCODONE 5 mg Oral Tablet; Drug: Acetaminophen 500 mg Tab; Drug: Ibuprofen 600 mg |
| No Opioid prescription | Active comparator | Ibuprofen 600mg every 6 hours x 48 hours then as needed (total 30 tablets). If allergy or contraindication to ibuprofen, will receive Meloxicam 15mg daily x 48 hours then as needed
Acetaminophen 500mg every 6 hours x 48 hours then as needed (total 30 tablets) Receives: Drug: Acetaminophen 500 mg Tab; Drug: Ibuprofen 600 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
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
Measured: 7 days
Secondary outcomes (9)
Satisfaction of pain control on postoperative day one
Overall satisfaction of pain control on postoperative day one (binary question - Yes/No)
Measured: 1 day
Satisfaction of pain control on postoperative day seven
Overall satisfaction of pain control on postoperative day seven (binary question - Yes/No)
Measured: 7 days
Mobility on postoperative day one
Satisfaction with mobility on postoperative day one (binary question - Yes/No)
Measured: 1 day
Mobility on postoperative day seven
Satisfaction with mobility on postoperative day seven (binary question - Yes/No)
Measured: 7 days
Total opioid consumption on postoperative day one
Total narcotic consumption by postoperative day one (in morphine milligram equivalent)
Measured: 1 day
Total opioid consumption on postoperative day seven
Total narcotic consumption by postoperative day seven (in morphine milligram equivalent)
Measured: 7 days
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)
Measured: 1 day
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)
Measured: 7 days
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)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start12 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mostafa Borahay, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548582
- Sponsor's protocol ID
- IRB00345074
- Status last verified
- Jan 2026
- First submitted
- 16 Sep 2022
- Last updated
- 12 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Leaf MC, Wainger J, Frost A, Musselman K, Patzkowsky K, Simpson K, Wu H, Vaidya D, Ma J, AlAshqar A, Wang KC, Borahay MA. Evaluating Routine Opioid Compared With Nonopioid Prescribing After Laparoscopic Hysterectomy: A Randomized Controlled Trial. Obstet Gynecol. 2026 Jul 30. doi: 10.1097/AOG.0000000000006378. Online ahead of print.
PubMed 42535875
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Study Reduced Opioid Prescription After Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT05548582
- Acronym / sponsor ID
- IRB00345074
- Conditions
- Pain, Postoperative, Opioid Misuse, Opioid Use, Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-operative opioid prescription | Other | Drug: OxyCODONE 5 mg Oral Tablet, Drug: Acetaminophen 500 mg Tab, Drug: Ibuprofen 600 mgIbuprofen 600mg every 6 hours x 48 hours then as needed (total 30 tablets). If allergy or contraindication to ibuprofen, then will receive Meloxicam 15mg daily x 48 hours then as needed Acetaminophen 500mg every 6 hours x 48 hours then as needed (total 30 tablets) Oxycodone 5mg every 4 hours as needed (total 12 tablets) |
| No Opioid prescription | Active comparator | Drug: Acetaminophen 500 mg Tab, Drug: Ibuprofen 600 mgIbuprofen 600mg every 6 hours x 48 hours then as needed (total 30 tablets). If allergy or contraindication to ibuprofen, will receive Meloxicam 15mg daily x 48 hours then as needed Acetaminophen 500mg every 6 hours x 48 hours then as needed (total 30 tablets) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over the age of 18 undergoing outpatient laparoscopic (conventional or robotic) hysterectomy for benign indications
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxyCODONE 5 mg Oral TabletNo opioid prescription after laparoscopic hysterectomy | Drug | Post-operative opioid prescription |
| Acetaminophen 500 mg TabStandard prescription | Drug | No Opioid prescription, Post-operative opioid prescription |
| Ibuprofen 600 mgStandard prescription | Drug | No Opioid prescription, Post-operative opioid prescription |
Primary outcome
Pain score on post-operative day one
Time frame: 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
Time frame: 7 days
Numeric pain score on post-operative day seven: patient reported pain using the Likert pain scale from 0 to 10
9 secondary outcomes
Satisfaction of pain control on postoperative day one
Time frame: 1 day
Satisfaction of pain control on postoperative day seven
Time frame: 7 days
Mobility on postoperative day one
Time frame: 1 day
Mobility on postoperative day seven
Time frame: 7 days
Total opioid consumption on postoperative day one
Time frame: 1 day
Total opioid consumption on postoperative day seven
Time frame: 7 days
Opioid related side effects on postoperative day one
Time frame: 1 day
Opioid related side effects on postoperative day seven
Time frame: 7 days
Unplanned calls/visits
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Derived from this study: PubMed 42535875Leaf MC, Wainger J, Frost A, Musselman K, Patzkowsky K, Simpson K, Wu H, Vaidya D, Ma J, AlAshqar A, Wang KC, Borahay MA. Evaluating Routine Opioid Compared With Nonopioid Prescribing After Laparoscopic Hysterectomy: A Randomized Controlled Trial. Obstet Gynecol. 2026 Jul 30. doi: 10.1097/AOG.0000000000006378. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mostafa Borahay principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OxyCODONE 5 mg Oral Tablet, Acetaminophen 500 mg Tab and Ibuprofen 600 mg in people with Pain, Postoperative and Opioid Misuse, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score on post-operative day one (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05548582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.