SurgeryPhase 2NCT03588910
Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription
A Phase 2 study testing Acetaminophen, Ibuprofen 600 mg and Oxycodone in people with Surgery, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Currently there is a nationwide epidemic in opioid abuse and overdose deaths. While the opioid epidemic is multi-factorial one major source of excess opioids may be over-prescribing in the post-operative period. 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
- Surgery
- What is being tested?
- Acetaminophen, Ibuprofen 600 mg and Oxycodone
- 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
- 8 Aug 2018to 4 Aug 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Must be over 18 years of age
- Scheduled for outpatient gynecologic laparoscopy
Who cannot join
- Significant renal or liver disease is present that would alter prescribing patterns
- Chronic opioid use or abuse
- Allergy to acetaminophen, ibuprofen, other nsaids or narcotic medications
- Conversion of surgery to exploratory laparotomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Ambulatory Gynecologic Surgery: Finding the Optimal Postoperative Opioid Prescription
Currently there is a nationwide epidemic in opioid abuse and overdose deaths. While the opioid epidemic is multi-factorial one major source of excess opioids may be over-prescribing in the post-operative period. There is wide variation in the prescribing practices for post-operative pain control and there is no standard of care for pain control after minor laparoscopic surgery in general or after gynecologic laparoscopy. There is also evidence to show that on average half of the opioids prescribed are unused by the patient. The aim of the study is to evaluate two opioid prescription regimens.
Read the detailed description
This will be a randomized controlled study enrolling participants scheduled for outpatient minor laparoscopic gynecologic surgery. This is a two arm study consisting of 60 subjects in each arm. The participants will be randomized at the time of enrollment. We will use computer generated blocks of four participants. Both arms of participants will receive the same non-narcotic pain medication prescriptions which will include fifty tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and twenty-five tablets ibuprofen 600mg (1 tablet every 6 hours as needed). The arms will only differ in the number of tablets of oxycodone prescribed. In one arm (experimental) subjects will receive five tablets of oxycodone 5mg (1 tablet every 6 hours as needed) and the other arm (comparator) ten tablets of oxycodone 5mg (1 tablet every 6 hours as needed). Both prescription regimens are within the range of normal clinical practice for post-operative pain control.
The participants will receive a telephone call by administrative staff, who is not directly involved in the participants care or data collection for the study subjects, on postoperative day 1 and 7. The participants will all be scheduled for a 2- week post-operative follow up with the surgeon in the office. The primary outcome to be assessed will be number of opioids used by the participants at 24 hours and 7 days post-operative. The primary hypothesis is that participants prescribed only 5 tabs of oxycodone will not require more medication. The secondary hypothesis is that the pain scores between the two groups will not be different. The other variables being studied include the following: having had a post-operative bowel movement, presence of nausea, number of ibuprofen, acetaminophen tablets remaining, calls to the office prior to the follow up visit for pain issues, and urgent or emergency department visits for pain issues. These assessments will be asked during the brief telephone calls and also at the postoperative visit.
All participants will be given the clinic phone number and advised to call with any questions or clinical concerns. The participants will be advised if possible to return to a Montefiore Emergency Department or gynecologic provider in case of an urgent issue prior to the 2 week postoperative visit, as opposed to an outside facility.
- Conditions
- Surgery
- Being tested
- Acetaminophen, Ibuprofen 600 mg, Oxycodone
- Keywords
- ambulatory, narcotics, opioids, postoperative, gynecology, laparoscopy, pain, surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Tylenol
50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
Ibuprofen 600 mgDrug
Also called Motrin
25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
OxycodoneDrug
The number of tablets of oxycodone prescribed is the only difference between the two arms.
| Study group | Role | What they receive |
|---|---|---|
| Number of oxycodone tablets typically prescribed | Active comparator | Participants will receive a prescription for 10 tablets of 5 mg oxycodone (1 tablet every 6 hours as needed) as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed). Receives: Drug: Acetaminophen; Drug: Ibuprofen 600 mg; Drug: Oxycodone |
| Half the number of oxycodone tablets typically prescribed | Experimental | Participants will receive 5 tablets of 5mg oxycodone as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed). Receives: Drug: Acetaminophen; Drug: Ibuprofen 600 mg; Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Oxycodone Tablets Used Day 1
During the survey phone call on day 1, participants will be asked to report the total number of oxycodone tablets use since the surgery.
Measured: 24 hours post-operative
Number of Oxycodone Tablets Used as Reported by Participants 1 Week After Surgery
During the survey phone call on day 7, participants will be asked to report the total number of oxycodone tablets used since the surgery.
Measured: 7 days post-operative
Secondary outcomes (3)
Self Reported Pain Score on Post Operative Day 1 (Numeric Pain Reporting Score: NRS)
Participants will be surveyed during the phone call survey to rate pain score on a scale from 0 (no pain), to 10 (severe pain)
Measured: 1 day post operative
Self Reported Pain Score on Post Operative Day 7 (Numeric Pain Reporting Score: NRS)
Participants will be surveyed during the phone call survey to rate pain score on a scale from 0 (no pain), to 10 (severe pain)
Measured: 7 days post operative
Additional Contacts With Provider
By chart review, unscheduled interactions with the healthcare system related to pain will be counted.These will include phone calls related to pain, unscheduled visits to the office or emergency department
Measured: 1 week post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start8 Aug 2018
- Primary completion4 Jul 2019
- Study completion4 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomized to receive one of two prescription regimens.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kari Plewniak, Montefiore Medical Center
- Investigators
- Ja Hyun Shin, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588910
- Sponsor's protocol ID
- 2018-8755
- Status last verified
- Jul 2021
- First submitted
- 16 Feb 2018
- Last updated
- 13 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thomazeau J, Rouquette A, Martinez V, Rabuel C, Prince N, Laplanche JL, Nizard R, Bergmann JF, Perrot S, Lloret-Linares C. Acute pain Factors predictive of post-operative pain and opioid requirement in multimodal analgesia following knee replacement. Eur J Pain. 2016 May;20(5):822-32. doi: 10.1002/ejp.808. Epub 2015 Oct 30.
PubMed 26517014De Oliveira GS Jr, Ahmad S, Fitzgerald PC, Marcus RJ, Altman CS, Panjwani AS, McCarthy RJ. Dose ranging study on the effect of preoperative dexamethasone on postoperative quality of recovery and opioid consumption after ambulatory gynaecological surgery. Br J Anaesth. 2011 Sep;107(3):362-71. doi: 10.1093/bja/aer156. Epub 2011 Jun 13.
PubMed 21669954As-Sanie S, Till SR, Mowers EL, Lim CS, Skinner BD, Fritsch L, Tsodikov A, Dalton VK, Clauw DJ, Brummett CM. Opioid Prescribing Patterns, Patient Use, and Postoperative Pain After Hysterectomy for Benign Indications. Obstet Gynecol. 2017 Dec;130(6):1261-1268. doi: 10.1097/AOG.0000000000002344.
PubMed 29112660Baruch AD, Morgan DM, Dalton VK, Swenson C. Opioid Prescribing Patterns by Obstetrics and Gynecology Residents in the United States. Subst Use Misuse. 2018 Jan 2;53(1):70-76. doi: 10.1080/10826084.2017.1323928. Epub 2017 Sep 1.
PubMed 28862884Darnall B, Li H. Hysterectomy and predictors for opioid prescription in a chronic pain clinic sample. Pain Med. 2011 Feb;12(2):196-203. doi: 10.1111/j.1526-4637.2010.01038.x. Epub 2011 Jan 11.
PubMed 21223499Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.
PubMed 27631771
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Gynecologic Surgery: Finding the Optimal Postoperative Opioid Prescription
- ClinicalTrials.gov ID
- NCT03588910
- Acronym / sponsor ID
- 2018-8755
- Conditions
- Surgery
- Keywords
- ambulatory, narcotics, opioids, postoperative, gynecology, laparoscopy, pain, surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 4 Jul 2019 (actual)
- Study completion
- 4 Aug 2019 (actual)
- First posted
- 17 Jul 2018 (actual)
- Results
- Posted 13 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently there is a nationwide epidemic in opioid abuse and overdose deaths. While the opioid epidemic is multi-factorial one major source of excess opioids may be over-prescribing in the post-operative period. There is wide variation in the prescribing practices for post-operative pain control and there is no standard of care for pain control after minor laparoscopic surgery in general or after gynecologic laparoscopy. There is also evidence to show that on average half of the opioids prescribed are unused by the patient. The aim of the study is to evaluate two opioid prescription regimens.
Detailed description
This will be a randomized controlled study enrolling participants scheduled for outpatient minor laparoscopic gynecologic surgery. This is a two arm study consisting of 60 subjects in each arm. The participants will be randomized at the time of enrollment. We will use computer generated blocks of four participants. Both arms of participants will receive the same non-narcotic pain medication prescriptions which will include fifty tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and twenty-five tablets ibuprofen 600mg (1 tablet every 6 hours as needed). The arms will only differ in the number of tablets of oxycodone prescribed. In one arm (experimental) subjects will receive five tablets of oxycodone 5mg (1 tablet every 6 hours as needed) and the other arm (comparator) ten tablets of oxycodone 5mg (1 tablet every 6 hours as needed). Both prescription regimens are within the range of normal clinical practice for post-operative pain control.
The participants will receive a telephone call by administrative staff, who is not directly involved in the participants care or data collection for the study subjects, on postoperative day 1 and 7. The participants will all be scheduled for a 2- week post-operative follow up with the surgeon in the office. The primary outcome to be assessed will be number of opioids used by the participants at 24 hours and 7 days post-operative. The primary hypothesis is that participants prescribed only 5 tabs of oxycodone will not require more medication. The secondary hypothesis is that the pain scores between the two groups will not be different. The other variables being studied include the following: having had a post-operative bowel movement, presence of nausea, number of ibuprofen, acetaminophen tablets remaining, calls to the office prior to the follow up visit for pain issues, and urgent or emergency department visits for pain issues. These assessments will be asked during the brief telephone calls and also at the postoperative visit.
All participants will be given the clinic phone number and advised to call with any questions or clinical concerns. The participants will be advised if possible to return to a Montefiore Emergency Department or gynecologic provider in case of an urgent issue prior to the 2 week postoperative visit, as opposed to an outside facility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are randomized to receive one of two prescription regimens.
| Arm | Type | Receives |
|---|---|---|
| Number of oxycodone tablets typically prescribed | Active comparator | Drug: Acetaminophen, Drug: Ibuprofen 600 mg, Drug: OxycodoneParticipants will receive a prescription for 10 tablets of 5 mg oxycodone (1 tablet every 6 hours as needed) as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed). |
| Half the number of oxycodone tablets typically prescribed | Experimental | Drug: Acetaminophen, Drug: Ibuprofen 600 mg, Drug: OxycodoneParticipants will receive 5 tablets of 5mg oxycodone as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be over 18 years of age
- Scheduled for outpatient gynecologic laparoscopy
Key exclusion criteria (4 listed)
- Significant renal or liver disease is present that would alter prescribing patterns
- Chronic opioid use or abuse
- Allergy to acetaminophen, ibuprofen, other nsaids or narcotic medications
- Conversion of surgery to exploratory laparotomy
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 |
|---|---|---|
| AcetaminophenAlso: Tylenol50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) | Drug | Half the number of oxycodone tablets typically prescribed, Number of oxycodone tablets typically prescribed |
| Ibuprofen 600 mgAlso: Motrin25 tablets ibuprofen 600mg (1tablet every 6 hours as needed) | Drug | Half the number of oxycodone tablets typically prescribed, Number of oxycodone tablets typically prescribed |
| OxycodoneThe number of tablets of oxycodone prescribed is the only difference between the two arms. | Drug | Half the number of oxycodone tablets typically prescribed, Number of oxycodone tablets typically prescribed |
Primary outcome
Number of Oxycodone Tablets Used Day 1
Time frame: 24 hours post-operative
During the survey phone call on day 1, participants will be asked to report the total number of oxycodone tablets use since the surgery.
Number of Oxycodone Tablets Used as Reported by Participants 1 Week After Surgery
Time frame: 7 days post-operative
During the survey phone call on day 7, participants will be asked to report the total number of oxycodone tablets used since the surgery.
3 secondary outcomes
Self Reported Pain Score on Post Operative Day 1 (Numeric Pain Reporting Score: NRS)
Time frame: 1 day post operative
Self Reported Pain Score on Post Operative Day 7 (Numeric Pain Reporting Score: NRS)
Time frame: 7 days post operative
Additional Contacts With Provider
Time frame: 1 week post operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26517014Thomazeau J, Rouquette A, Martinez V, Rabuel C, Prince N, Laplanche JL, Nizard R, Bergmann JF, Perrot S, Lloret-Linares C. Acute pain Factors predictive of post-operative pain and opioid requirement in multimodal analgesia following knee replacement. Eur J Pain. 2016 May;20(5):822-32. doi: 10.1002/ejp.808. Epub 2015 Oct 30.
- Background: PubMed 21669954De Oliveira GS Jr, Ahmad S, Fitzgerald PC, Marcus RJ, Altman CS, Panjwani AS, McCarthy RJ. Dose ranging study on the effect of preoperative dexamethasone on postoperative quality of recovery and opioid consumption after ambulatory gynaecological surgery. Br J Anaesth. 2011 Sep;107(3):362-71. doi: 10.1093/bja/aer156. Epub 2011 Jun 13.
- Background: PubMed 29112660As-Sanie S, Till SR, Mowers EL, Lim CS, Skinner BD, Fritsch L, Tsodikov A, Dalton VK, Clauw DJ, Brummett CM. Opioid Prescribing Patterns, Patient Use, and Postoperative Pain After Hysterectomy for Benign Indications. Obstet Gynecol. 2017 Dec;130(6):1261-1268. doi: 10.1097/AOG.0000000000002344.
- Background: PubMed 28862884Baruch AD, Morgan DM, Dalton VK, Swenson C. Opioid Prescribing Patterns by Obstetrics and Gynecology Residents in the United States. Subst Use Misuse. 2018 Jan 2;53(1):70-76. doi: 10.1080/10826084.2017.1323928. Epub 2017 Sep 1.
- Background: PubMed 21223499Darnall B, Li H. Hysterectomy and predictors for opioid prescription in a chronic pain clinic sample. Pain Med. 2011 Feb;12(2):196-203. doi: 10.1111/j.1526-4637.2010.01038.x. Epub 2011 Jan 11.
- Background: PubMed 27631771Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.
- Individual participant dataSharing planned: No
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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.
Ja Hyun Shin, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetaminophen, Ibuprofen 600 mg and Oxycodone in people with Surgery, run by Montefiore Medical Center 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 13 Aug 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Oxycodone Tablets Used Day 1 (time frame: 24 hours post-operative). 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 NCT03588910, which also lists 6 linked publications.
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 13 Aug 2021.