Pain, PostoperativeeNARCOSNCT04837014
Eliminating Narcotic Prescriptions from Outpatient Minimally Invasive Gynecologic Surgery
A study testing prescription for regular acetaminophen and naproxen and prescription for regular acetaminophen , naproxen and dilaudid in people with Pain, Postoperative and Opioid Use, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Laparoscopic gynecologic surgeries are generally very well tolerated procedures, and patients are able to go home on the same day, with a prescription for pain control. There is currently a very wide range of prescription practice within the gynecology community in regards to opioids following surgery, and patients… 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 Use
- What is being tested?
- prescription for regular acetaminophen and naproxen and prescription for regular acetaminophen , naproxen and dilaudid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jul 2022to 21 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women undergoing elective outpatient gynecologic laparoscopy
- Able to provide informed consent
- Planned for same day discharge
Who cannot join
- Chronic pain conditions including, but not limited to: chronic pelvic pain, fibromyalgia, connective tissue disorders, migraines on medication, severe osteoarthritis, sciatica, degenerative disk disease
- Regular use of analgesia or narcotics. Defined as use of pain medication on most days of the week, most weeks of the month
- History of substance abuse (opioid addiction, IV drug use, etc.)
- Known depression or anxiety conditions with or without medication
- Eastern Cooperative Oncology Group (ECOG) performance status 3 or greater
- Current or recent use of pain modulators such as pregabalin or gabapentin (one month pre-operatively).
Show all 12Show fewer
- Allergy or contraindication to acetaminophen or NSAIDs or hydromorphone/narcotics
- Intraoperative complications :
- Conversion to laparotomy or mini-laparotomy > 4 cm
- Intra-operative gastrointestinal or urologic injury
- Intra-operative hemorrhage or need for blood transfusion
- Need for admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eliminating Narcotic Prescriptions from Outpatient Minimally Invasive Gynecologic Surgery: a Randomized Controlled Trial
Laparoscopic gynecologic surgeries are generally very well tolerated procedures, and patients are able to go home on the same day, with a prescription for pain control. There is currently a very wide range of prescription practice within the gynecology community in regards to opioids following surgery, and patients are going home with anything from zero to 5 or even 20 tabs of narcotics.
Aside from negative side effect of opioids (like nausea/vomiting, dizziness, constipation, and possibly addiction), unnecessary opioid prescriptions and excess unused narcotics is one of the major contributors to narcotic abuse in the community, worsening an ongoing nationwide opioid crisis. Although most patients report low pain level following these kinds of procedure, there are no current standard prescriptions after gynecologic laparoscopy.
In an effort to standardize discharge prescriptions following gynecologic laparoscopy, this study aims to find an optimal regimen for pain control in the post-operative period following laparoscopic gynecologic surgery. There will be 2 standardized set of discharge prescriptions to which patient will be randomized; both containing multimodal medications for pain control. Pain control, and patients satisfaction will be measured in the first post-operative week.
Read the detailed description
Narcotic prescribing patterns vary greatly among gynecologists performing minimally invasive gynecologic surgery (MIGS). There is no clear consensus or established guideline regarding the choice of narcotic or total amount to be prescribed, if any, for MIGS. These represent a generally well-tolerated group of procedures that are less painful than conventional open surgery. Unnecessary opioid prescriptions and excess unused narcotics have been identified as major contributors to narcotic abuse in the community, and efforts geared towards minimizing unnecessary narcotic prescriptions may help curb the growing opioid crisis.
This study suggests eliminating opioids from discharge prescriptions following outpatient MIGS in select patients. Given the general tolerability and low pain associated with MIGS, the investigators hypothesize that elimination of narcotics from post-operative pain control, in conjunction with regular use of non-narcotic analgesics, will result in analgesia and early recovery that is no worse than a standard narcotic-containing discharge prescription.
Women undergoing elective outpatient laparoscopic gynecologic surgery at two medical center associated with the McGill University Health Centre will be recruited and screened for exclusion criteria. Patients will be randomly allocated to either intervention or control groups in a one to one fashion. Patients in both intervention and control group will undergo surgery under a standardized anesthesia protocol. Important surgical steps that can affect post-operative pain will be standardised and recorded with a surgical checklist to reduce inter-surgeon variability. Patient allocated to the intervention arm will then be discharged home with a prescription for regular acetaminophen and naproxen for 48 hours, and then as needed for one week's duration. Patient in control group will be discharge with a standard prescription of five tabs of 1 mg hydromorphone, with regular non-opioid analgesic use.
All patient will be contacted on day one and seven after surgery to evaluate pain scores, mobility, adequacy of analgesia, adherence to treatment, side-effects, and total opioid consumption.
- Conditions
- Pain, Postoperative, Opioid Use
- Being tested
- prescription for regular acetaminophen and naproxen, prescription for regular acetaminophen , naproxen and dilaudid
- Keywords
- Gynecology, Minimally invasive surgery, Laparoscopy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prescription for regular acetaminophen and naproxenOther
Patient allocated to the intervention arm will be discharged home with a prescription for regular acetaminophen and naproxen for 48 hours, and then prn for one week's duration. No narcotic will be prescribed at discharge post-operatively.
prescription for regular acetaminophen , naproxen and dilaudidOther
prescription for regular acetaminophen , naproxen and dilaudid
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen and naproxen only arm | Experimental | Patient allocated to the intervention arm will be discharged home with a prescription for regular acetaminophen and naproxen for 48 hours, and then as needed for one week's duration. Receives: Other: prescription for regular acetaminophen and naproxen |
| Acetaminophen, naproxen and dilaudid arm | Active comparator | Patient allocated to the control group will be discharged home with a prescription for regular acetaminophen, naproxen, and 5 tabs of hydromorphone 1 mg, with instruction to prioritize non opioid analgesic as first line. Receives: Other: prescription for regular acetaminophen , naproxen and dilaudid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score on post-operative day one
The primary outcome of this study is patient reported pain using an 11-point Numerical Rating Scale (NRS) on post-operative day two, on a scale from 0 to 10 in which higher scores indicate higher pain (worse pain control).
Measured: Post-operative day one
Secondary outcomes (6)
Patient mobility and satisfaction of analgesia
Patients will receive a phone call on post-operative day one and seven and will be asked a standardised set of questions binary question (Yes / No) to evaluate patient mobility and satisfaction of analgesia.
Measured: Post-operative day one and seven
Total narcotic consumption in the first post-operative week
Patients will receive a phone call on post-operative day one and seven and will be asked total amount of narcotic consumed since discharge from the hospital, including need for rescue prescription
Measured: Post-operative day seven
Opioid related side effect
Patients will receive a phone call on post-operative day one and seven and will be inquired about specific opioid side effect.
Measured: First post-operative week (Day 7)
Unplanned return to emergency room / clinic
Patients will receive a phone call on post-operative day one and seven and will be inquired about any unplanned visit to emergency room / clinic since discharged from the hospital.
Measured: First post-operative week (Day 7)
Overall satisfaction with pain control
Patients will receive a phone call on post-operative day one and seven and will be asked about overall satisfaction with pain control via standardised questionnaire.
Measured: First post-operative week (Day 7)
Pain score on post-operative day one
Patient reported pain using an 11-point Numerical Rating Scale (NRS) on post-operative day one, on a scale from 0 to 10 in which higher scores indicate higher pain (worse pain control).
Measured: Post-operative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start4 Jul 2022
- Primary completion15 Oct 2024
- Study completion21 Oct 2024
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 McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Model description
- In this randomized controlled trial, consented patient will be randomly allocated to either intervention or control groups in a 1:1 fashion. Allocation will be determined by a computerized randomization generator with block randomization in groups of four. Allocations will be placed in sequentially numbered, sealed, opaque envelopes to be opened only upon completion of surgery of consenting patients.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Zakhari, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Andrew Zakhari, M.D., Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837014
- Sponsor's protocol ID
- F11-70846
- Acronym
- eNARCOS
- Status last verified
- Oct 2024
- First submitted
- 5 Apr 2021
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zakhari A, Desilets J, Della Rocca C, Shan WLP, Nguyen DB, Gilbert L, Smith JP, Krishnamurthy S, Mansour FW. Eliminating opioid prescriptions from outpatient minimally invasive gynecologic surgery: a randomized trial. Nat Med. 2026 Feb;32(2):746-751. doi: 10.1038/s41591-025-04096-6. Epub 2026 Jan 5.
PubMed 41491106
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eliminating Narcotic Prescriptions from Outpatient Minimally Invasive Gynecologic Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04837014
- Acronym / sponsor ID
- eNARCOS / F11-70846
- Conditions
- Pain, Postoperative, Opioid Use
- Keywords
- Gynecology, Minimally invasive surgery, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 8 Apr 2021 (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.
Laparoscopic gynecologic surgeries are generally very well tolerated procedures, and patients are able to go home on the same day, with a prescription for pain control. There is currently a very wide range of prescription practice within the gynecology community in regards to opioids following surgery, and patients are going home with anything from zero to 5 or even 20 tabs of narcotics.
Aside from negative side effect of opioids (like nausea/vomiting, dizziness, constipation, and possibly addiction), unnecessary opioid prescriptions and excess unused narcotics is one of the major contributors to narcotic abuse in the community, worsening an ongoing nationwide opioid crisis. Although most patients report low pain level following these kinds of procedure, there are no current standard prescriptions after gynecologic laparoscopy.
In an effort to standardize discharge prescriptions following gynecologic laparoscopy, this study aims to find an optimal regimen for pain control in the post-operative period following laparoscopic gynecologic surgery. There will be 2 standardized set of discharge prescriptions to which patient will be randomized; both containing multimodal medications for pain control. Pain control, and patients satisfaction will be measured in the first post-operative week.
Detailed description
Narcotic prescribing patterns vary greatly among gynecologists performing minimally invasive gynecologic surgery (MIGS). There is no clear consensus or established guideline regarding the choice of narcotic or total amount to be prescribed, if any, for MIGS. These represent a generally well-tolerated group of procedures that are less painful than conventional open surgery. Unnecessary opioid prescriptions and excess unused narcotics have been identified as major contributors to narcotic abuse in the community, and efforts geared towards minimizing unnecessary narcotic prescriptions may help curb the growing opioid crisis.
This study suggests eliminating opioids from discharge prescriptions following outpatient MIGS in select patients. Given the general tolerability and low pain associated with MIGS, the investigators hypothesize that elimination of narcotics from post-operative pain control, in conjunction with regular use of non-narcotic analgesics, will result in analgesia and early recovery that is no worse than a standard narcotic-containing discharge prescription.
Women undergoing elective outpatient laparoscopic gynecologic surgery at two medical center associated with the McGill University Health Centre will be recruited and screened for exclusion criteria. Patients will be randomly allocated to either intervention or control groups in a one to one fashion. Patients in both intervention and control group will undergo surgery under a standardized anesthesia protocol. Important surgical steps that can affect post-operative pain will be standardised and recorded with a surgical checklist to reduce inter-surgeon variability. Patient allocated to the intervention arm will then be discharged home with a prescription for regular acetaminophen and naproxen for 48 hours, and then as needed for one week's duration. Patient in control group will be discharge with a standard prescription of five tabs of 1 mg hydromorphone, with regular non-opioid analgesic use.
All patient will be contacted on day one and seven after surgery to evaluate pain scores, mobility, adequacy of analgesia, adherence to treatment, side-effects, and total opioid consumption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In this randomized controlled trial, consented patient will be randomly allocated to either intervention or control groups in a 1:1 fashion. Allocation will be determined by a computerized randomization generator with block randomization in groups of four. Allocations will be placed in sequentially numbered, sealed, opaque envelopes to be opened only upon completion of surgery of consenting patients.
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen and naproxen only arm | Experimental | Other: prescription for regular acetaminophen and naproxenPatient allocated to the intervention arm will be discharged home with a prescription for regular acetaminophen and naproxen for 48 hours, and then as needed for one week's duration. |
| Acetaminophen, naproxen and dilaudid arm | Active comparator | Other: prescription for regular acetaminophen , naproxen and dilaudidPatient allocated to the control group will be discharged home with a prescription for regular acetaminophen, naproxen, and 5 tabs of hydromorphone 1 mg, with instruction to prioritize non opioid analgesic as first line. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women undergoing elective outpatient gynecologic laparoscopy
- Able to provide informed consent
- Planned for same day discharge
Key exclusion criteria (12 listed)
- Chronic pain conditions including, but not limited to: chronic pelvic pain, fibromyalgia, connective tissue disorders, migraines on medication, severe osteoarthritis, sciatica, degenerative disk disease
- Regular use of analgesia or narcotics. Defined as use of pain medication on most days of the week, most weeks of the month
- History of substance abuse (opioid addiction, IV drug use, etc.)
- Known depression or anxiety conditions with or without medication
- Eastern Cooperative Oncology Group (ECOG) performance status 3 or greater
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 |
|---|---|---|
| prescription for regular acetaminophen and naproxenPatient allocated to the intervention arm will be discharged home with a prescription for regular acetaminophen and naproxen for 48 hours, and then prn for one week's duration. No narcotic will be prescribed at discharge post-operatively. | Other | Acetaminophen and naproxen only arm |
| prescription for regular acetaminophen , naproxen and dilaudidprescription for regular acetaminophen , naproxen and dilaudid | Other | Acetaminophen, naproxen and dilaudid arm |
Primary outcome
Pain score on post-operative day one
Time frame: Post-operative day one
The primary outcome of this study is patient reported pain using an 11-point Numerical Rating Scale (NRS) on post-operative day two, on a scale from 0 to 10 in which higher scores indicate higher pain (worse pain control).
6 secondary outcomes
Patient mobility and satisfaction of analgesia
Time frame: Post-operative day one and seven
Total narcotic consumption in the first post-operative week
Time frame: Post-operative day seven
Opioid related side effect
Time frame: First post-operative week (Day 7)
Unplanned return to emergency room / clinic
Time frame: First post-operative week (Day 7)
Overall satisfaction with pain control
Time frame: First post-operative week (Day 7)
Pain score on post-operative day one
Time frame: Post-operative day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Derived from this study: PubMed 41491106Zakhari A, Desilets J, Della Rocca C, Shan WLP, Nguyen DB, Gilbert L, Smith JP, Krishnamurthy S, Mansour FW. Eliminating opioid prescriptions from outpatient minimally invasive gynecologic surgery: a randomized trial. Nat Med. 2026 Feb;32(2):746-751. doi: 10.1038/s41591-025-04096-6. Epub 2026 Jan 5.
- 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.
Andrew Zakhari, M.D. principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prescription for regular acetaminophen and naproxen and prescription for regular acetaminophen , naproxen and dilaudid in people with Pain, Postoperative and Opioid Use, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 3 inclusion and 12 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 24 Oct 2024. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Post-operative day one). 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 NCT04837014, 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 24 Oct 2024.