Opioid UsePhase 3NCT05386069
Does a Non-Opioid Multimodal Pain (NOMO) Protocol Decrease Narcotic Use
A Phase 3 study testing NOMO Protocol in people with Opioid Use, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
The objective of this study is to evaluate narcotic use after implementation of a Non-Opioid Multimodal Pain (NOMO) protocol in patients who are undergoing a urogynecologic procedure. 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
- Opioid Use
- What is being tested?
- NOMO Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2019to 1 Jun 2021
- Phase
- Phase 3
- 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
- English-speaking females
- greater than or equal to 18 years old
- scheduled for a urogynecologic procedure at GHS requiring inpatient stay or extended observation.
Who cannot join
- less than 18 years of age
- non-English speaking patients
- unscheduled urogynecologic surgeries
- patients expected to undergo a simple reconstructive surgery with same-day discharge,
- history of chronic pain
- chronic Lyrica or Celebrex use
Show all 11Show fewer
- psychiatric disorder, narcotic dependence or narcotic prescription in the past six weeks
- current liver disease
- kidney disease (defined as GFR <60)
- malignancy
- sulfa allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Prisma Health - Upstate
Greenville, South Carolina, 29615
About this study
Official title: The Effect of a Non-Opioid Multimodal Pain (NOMO) Protocol in Decreasing Narcotic Use After Urogynecologic Surgery
The objective of this study is to evaluate narcotic use after implementation of a Non-Opioid Multimodal Pain (NOMO) protocol in patients who are undergoing a urogynecologic procedure. The study will also evaluate secondary outcomes, including: post-operative pain rating, length of hospital stay, postoperative antiemetic use, bladder catheterization at discharge, number of post-operative phone calls, and rate of reported side effects of opioid use (nausea/constipation). Study participants will be asked to utilize the validated Brief Pain Inventory (appendix A) scale to assess post-operative pain levels. Based on inpatient post-operative opioid use and number of opioid pills prescribed at discharge, an attempt will be made to develop an algorithm for recommended opioid prescribing patterns.
Read the detailed description
The objective of this study is to evaluate narcotic use after implementation of a Non-Opioid Multimodal Pain (NOMO) protocol in patients who are undergoing a urogynecologic procedure. NOMO protocols seek to reduce the opioid usage for patients in the postoperative period. Patients will receive multiple pain medications (usually referred to as a "pain cocktail") that work on various pain receptors throughout the body. These medications are approved for pain control; but they have few side effects and less addictive properties. The study will also evaluate secondary outcomes, including: post-operative pain rating, length of hospital stay, postoperative antiemetic use, bladder catheterization at discharge, number of post-operative phone calls, and rate of reported side effects of opioid use (nausea/constipation). Study participants will be asked to utilize the validated Brief Pain Inventory (appendix A) scale to assess post-operative pain levels. Based on inpatient post-operative opioid use and number of opioid pills prescribed at discharge, an attempt will be made to develop an algorithm for recommended opioid prescribing patterns.
- Conditions
- Opioid Use
- Being tested
- NOMO Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOMO ProtocolDrug
Also called Standard Care
Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Routine Care per Anesthiologist/cRNA |
| Treatment Arm | Active comparator | Patients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail Receives: Drug: NOMO Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Milligram Equivalents Used During Inpatient Stay
Total morphine milligram equivalents calculated for each patient during their stay.
Measured: from immediately postoperative through discharge or 4 weeks, whichever comes first
Secondary outcomes (5)
Passage of Voiding Trial
percentage of patients who pass voiding trial on POD#1
Measured: from immediately postoperative through discharge or 4 weeks, whichever comes first
Anti-emetic Use
Did the patient require anti-emetics in the post-operative period
Measured: postoperative day 1 through day of discharge from hospital; all patients were dischard on post-op day 1
Patient Pain Score
Evaluated via the "Brief Pain Inventory (Short Form)"; rate pain on scale 0-10, 10 being worst
Measured: postoperative day 7
Prescription for Opioid at Discharge
Did the patient require a narcotic prescription
Measured: postoperative day 2 through postoperative day 7
Length of Hospital Stay
The average number of days patients were admitted as inpatient.
Measured: postoperative day 1 through discharge or 4 weeks, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start15 Nov 2019
- Primary completion1 Dec 2020
- Study completion1 Jun 2021
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 (1)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hema Brazell, MD, Principal investigator, Prisma Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386069
- Sponsor's protocol ID
- NOMO Protocol
- Status last verified
- May 2025
- First submitted
- 6 Apr 2020
- Last updated
- 23 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reagan KML, O'Sullivan DM, Gannon R, Steinberg AC. Decreasing postoperative narcotics in reconstructive pelvic surgery: a randomized controlled trial. Am J Obstet Gynecol. 2017 Sep;217(3):325.e1-325.e10. doi: 10.1016/j.ajog.2017.05.041. Epub 2017 May 25.
PubMed 28551445
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Non-Opioid Multimodal Pain (NOMO) Protocol in Decreasing Narcotic Use After Urogynecologic Surgery
- ClinicalTrials.gov ID
- NCT05386069
- Acronym / sponsor ID
- NOMO Protocol
- Conditions
- Opioid Use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 23 May 2022 (actual)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate narcotic use after implementation of a Non-Opioid Multimodal Pain (NOMO) protocol in patients who are undergoing a urogynecologic procedure. The study will also evaluate secondary outcomes, including: post-operative pain rating, length of hospital stay, postoperative antiemetic use, bladder catheterization at discharge, number of post-operative phone calls, and rate of reported side effects of opioid use (nausea/constipation). Study participants will be asked to utilize the validated Brief Pain Inventory (appendix A) scale to assess post-operative pain levels. Based on inpatient post-operative opioid use and number of opioid pills prescribed at discharge, an attempt will be made to develop an algorithm for recommended opioid prescribing patterns.
Detailed description
The objective of this study is to evaluate narcotic use after implementation of a Non-Opioid Multimodal Pain (NOMO) protocol in patients who are undergoing a urogynecologic procedure. NOMO protocols seek to reduce the opioid usage for patients in the postoperative period. Patients will receive multiple pain medications (usually referred to as a "pain cocktail") that work on various pain receptors throughout the body. These medications are approved for pain control; but they have few side effects and less addictive properties. The study will also evaluate secondary outcomes, including: post-operative pain rating, length of hospital stay, postoperative antiemetic use, bladder catheterization at discharge, number of post-operative phone calls, and rate of reported side effects of opioid use (nausea/constipation). Study participants will be asked to utilize the validated Brief Pain Inventory (appendix A) scale to assess post-operative pain levels. Based on inpatient post-operative opioid use and number of opioid pills prescribed at discharge, an attempt will be made to develop an algorithm for recommended opioid prescribing patterns.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Routine Care per Anesthiologist/cRNA |
| Treatment Arm | Active comparator | Drug: NOMO ProtocolPatients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking females
- greater than or equal to 18 years old
- scheduled for a urogynecologic procedure at GHS requiring inpatient stay or extended observation.
Key exclusion criteria (11 listed)
- less than 18 years of age
- non-English speaking patients
- unscheduled urogynecologic surgeries
- patients expected to undergo a simple reconstructive surgery with same-day discharge,
- history of chronic pain
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 |
|---|---|---|
| NOMO ProtocolAlso: Standard CareStandard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications | Drug | Treatment Arm |
Primary outcome
Morphine Milligram Equivalents Used During Inpatient Stay
Time frame: from immediately postoperative through discharge or 4 weeks, whichever comes first
Total morphine milligram equivalents calculated for each patient during their stay.
5 secondary outcomes
Passage of Voiding Trial
Time frame: from immediately postoperative through discharge or 4 weeks, whichever comes first
Anti-emetic Use
Time frame: postoperative day 1 through day of discharge from hospital; all patients were dischard on post-op day 1
Patient Pain Score
Time frame: postoperative day 7
Prescription for Opioid at Discharge
Time frame: postoperative day 2 through postoperative day 7
Length of Hospital Stay
Time frame: postoperative day 1 through discharge or 4 weeks, whichever comes first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28551445Reagan KML, O'Sullivan DM, Gannon R, Steinberg AC. Decreasing postoperative narcotics in reconstructive pelvic surgery: a randomized controlled trial. Am J Obstet Gynecol. 2017 Sep;217(3):325.e1-325.e10. doi: 10.1016/j.ajog.2017.05.041. Epub 2017 May 25.
- 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.
Hema Brazell, MD principal investigator
Prisma Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NOMO Protocol in people with Opioid Use, run by Prisma Health-Upstate 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 3 inclusion and 11 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 23 May 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 23 May 2025). 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?
Morphine Milligram Equivalents Used During Inpatient Stay (time frame: from immediately postoperative through discharge or 4 weeks, whichever comes first). 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 NCT05386069, 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 23 May 2025; AzTrials last refreshed its copy on 27 Oct 2026.