Opt-In Narcotics Protocol for Breast Surgery

(POINT-B Trial)

No longer recruiting at 1 trial location

Overseen By James Wu, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Narcotics

Disqualifiers: Complex surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to pain management after outpatient breast surgery. Instead of automatically providing opioid prescriptions, the study compares this usual method to an "opt-in" approach called the POINT Protocol, where patients decide if they want opioids. Those who opt out will be guided to use over-the-counter pain relief like acetaminophen or ibuprofen but can request opioids if needed. This trial suits patients undergoing breast surgery who do not currently use narcotics. The goal is to determine if patients can manage pain effectively without routine opioid prescriptions. As an unphased trial, it offers patients the chance to contribute to innovative pain management strategies without the pressure of new drug testing.

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but if you are currently using narcotics, you cannot participate.

What prior data suggests that this opt-in narcotics protocol is safe for outpatient breast surgery?

Research has shown that choosing between strong painkillers and over-the-counter options like acetaminophen or ibuprofen after breast surgery can be safe and effective. In studies where patients made this choice, they needed fewer strong painkillers and did not experience more pain. These studies also found that this approach reduced the use of strong painkillers and improved recovery after surgery without increasing pain.

These findings suggest that allowing patients to choose their pain management method is well-tolerated and may reduce the need for strong painkillers, making it a safe option for managing pain after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Opt-In Narcotics Protocol for breast surgery because it empowers patients to make informed decisions about their postoperative pain management. Unlike the standard care, which involves routinely prescribing narcotic pain medications like Norco, this protocol includes perioperative counseling that helps patients understand their options and potentially opt out of using narcotics altogether. This approach could reduce reliance on opioids, minimize side effects, and address concerns about opioid addiction, offering a more personalized and potentially safer recovery process for patients.

What evidence suggests that the POINT Protocol is effective for managing pain after breast surgery?

Research has shown that many patients don't need strong painkillers like opioids after breast surgery. In this trial, some participants will follow the Postoperative Opt-In Narcotic Treatment (POINT) plan, which studies have shown results in similar pain levels to those who receive regular opioid prescriptions. Another study revealed that opioids are often overprescribed, leaving many unused pills. Limiting opioid prescriptions to just a few days is both possible and effective. These findings suggest that using fewer opioids after surgery can manage pain just as well as using more. This approach may help reduce the risk of leftover pills being misused. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults who are having outpatient breast surgery and can understand written English. It's not for those currently using opioids or needing complex surgery with a longer hospital stay.

Inclusion Criteria

Understands written English

Undergoing outpatient breast surgery (less than 24 hour stay)

Exclusion Criteria

Increased complexity of surgery requiring longer hospital stay

You are currently taking opioids for pain relief.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo outpatient breast surgery and are randomized to either the opt-in protocol or usual care for postoperative pain management

1 week

1 visit (in-person) for surgery

Follow-up

Participants are monitored for pain scores and medication use through daily phone calls or electronic surveys, and evaluated at follow-up visits

1 week

1 visit (in-person), daily virtual check-ins

Long-term follow-up

Participants' opioid consumption and quality of life are assessed using PROMIS survey

Postoperative day 7

What Are the Treatments Tested in This Trial?

Interventions

• POINT Protocol
• Usual care

Trial Overview

The study compares an 'opt-in' approach, where patients choose if they want narcotics post-surgery, to the usual care of routinely providing opioid prescriptions. Participants will be randomly assigned to one of these two approaches.

How Is the Trial Designed?

Group I: POINT-B Experimental Treatment 1 Intervention

Patients will receive perioperative counseling on opioid consumption following breast surgery, both preoperatively and postoperatively. Upon discharge, patients will be asked whether they would like to be discharged with narcotic pain medication or not.

Group II: Usual Care Active Control 1 Intervention

Patients will receive equivalent of 5 tabs of Norco 5/325 mg upon discharge routinely

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

Residents learn and implement breast surgery ERAS protocols primarily through informal methods such as observing seniors and patient interactions, rather than through formal education, highlighting the importance of mentorship in surgical training.

A patient-centered culture significantly influences postoperative management and the success of same-day discharges, indicating that fostering this culture is crucial for effective implementation of ERAS protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to teach ERAS protocols: surgical residents' perspectives and perioperative practices for breast surgery patients. Jogerst, K., Coe, TM., Gupta, N., et al.[2023]

A standardized analgesia protocol implemented over 10 months significantly reduced postoperative pain among neurosurgery patients, with a 32% reduction in pain scores on the first postoperative day, indicating improved pain management practices.

The protocol not only lowered pain levels but also enhanced safety, as evidenced by a significant decrease in naloxone doses administered, suggesting fewer instances of opioid-related complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective time-series quality improvement trial of a standardized analgesia protocol to reduce postoperative pain among neurosurgery patients. Titsworth, WL., Abram, J., Guin, P., et al.[2022]

The implementation of an Enhanced Recovery After Surgery (ERAS) pathway for total skin-sparing mastectomy with immediate reconstruction significantly reduced total perioperative opioid consumption by 32% compared to a traditional approach, indicating improved pain management.

Patients in the ERAS group experienced a 22% lower incidence of post-operative nausea and vomiting (PONV) and reported less pain in recovery, demonstrating the efficacy of the multimodal approach in enhancing recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved analgesia and reduced post-operative nausea and vomiting after implementation of an enhanced recovery after surgery (ERAS) pathway for total mastectomy. Chiu, C., Aleshi, P., Esserman, LJ., et al.[2022]

The Enhanced Recovery After Surgery (ERAS) protocol significantly reduced the amount of opioids prescribed to patients after mastectomy, with the ERAS group receiving an average of only 2.0 oral morphine equivalents (OMEs) at discharge compared to 59.8 OMEs in the usual care group.

Patients following the ERAS protocol also reported lower postoperative pain scores, indicating that this multimodal analgesia approach not only decreases opioid use but also effectively manages pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mastectomy is no longer an indication for postoperative opioid prescription at discharge. Rojas, KE., Fortes, TA., Flom, PL., et al.[2020]

The implementation of a breast surgery-specific Enhanced Recovery After Surgery (ERAS) protocol allowed for the elimination of narcotic prescriptions at discharge, with ERAS patients receiving 0 morphine milligram equivalents (MMEs) compared to 54.5 MMEs for the control group, without compromising pain control.

Postoperative pain scores were similar between the ERAS and control groups, indicating that effective pain management can be achieved through opioid-sparing techniques, thus potentially reducing the risk of opioid misuse in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of a breast surgery Enhanced Recovery After Surgery (ERAS) protocol to eliminate narcotic prescription at discharge. Rojas, KE., Manasseh, DM., Flom, PL., et al.[2019]

The implementation of an Enhanced Recovery After Surgery (ERAS) protocol, which included preoperative education and multimodal pain control, led to a significant 41.5% reduction in opioid prescriptions for outpatient breast surgery patients, from an average of 216 oral morphine equivalents (OME) to 126.4 OMEs.

Patients in the ERAS group also experienced lower opioid consumption in the postanesthesia care unit (PACU) and had fewer needs for additional narcotic prescriptions postoperatively, indicating improved pain management without increasing complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreasing Opioids in Outpatient Breast Surgery with an Enhanced Recovery after Surgery Program and Preoperative Education. Wong, S., Lombana, NF., Falola, RA., et al.[2023]

The implementation of Enhanced Recovery Protocols (ERPs) significantly reduced the incidence of post-operative nausea and vomiting (PONV) in patients undergoing total mastectomy, with rates dropping from 40% in the usual care group to 21% in the ERP group.

Patients in the ERP group also experienced lower opioid consumption (44.1 oral morphine equivalents vs. 104.3 in the usual care group) and reported less pain, indicating that ERPs can improve patient outcomes while minimizing the use of narcotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-operative Nausea and Analgesia Following Total Mastectomy is Improved After Implementation of an Enhanced Recovery Protocol. Dinh, KH., McAuliffe, PF., Boisen, M., et al.[2021]

A review of narcotic prescriptions for 100 breast surgery patients revealed that the median number of pills prescribed was significantly reduced after departmental education, from 15 to 10 for excisional biopsy/lumpectomy and from 28 to 25 for mastectomy with reconstruction.

Most patients used far fewer narcotics than prescribed, with median usage of only 1 pill for excisional biopsy/lumpectomy and 3 pills for mastectomy, indicating that further reductions in prescriptions could be safely implemented without compromising pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Narcotic Prescriptions in Breast Surgery: A Prospective Analysis. Fan, B., Valente, SA., Shilad, S., et al.[2020]

In a study of 31 patients undergoing breast reduction surgery, those who received a local anesthetic pain pump with bupivacaine reported significantly lower pain scores and used fewer narcotics compared to those who received a saline placebo.

Patients receiving bupivacaine also experienced fewer episodes of postoperative nausea and vomiting, indicating that the local anesthetic not only alleviated pain but also improved overall recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A local anesthetic pump reduces postoperative pain and narcotic and antiemetic use in breast reconstruction surgery: a randomized controlled trial. Rawlani, V., Kryger, ZB., Lu, L., et al.[2021]

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