Opt-In Narcotics Protocol for Breast Surgery

(POINT-B Trial)

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: Unknown

109 Participants Needed

Trial Summary

What is the purpose of this trial?

In a recent study, researchers let patients choose what medications to go home with after endocrine surgery. This has not been done in outpatient breast surgery, though several institutions have moved towards avoiding opioids altogether after breast surgery. These institutions only prescribed rescue opioids upon request. The aim of this study is to compare a similar "opt-in" protocol for narcotics to usual care (where patients are routinely discharged with opioids) for outpatient breast surgery. This study will be designed as a randomized, controlled trial. When adult patients consent for outpatient breast surgery, the patients will be asked to participate in the study. Patients who are currently using narcotics would be excluded. The investigators would then randomize participants to the "opt-in" protocol versus being provided with a standard opioid prescription after surgery. Patients in the opt-in protocol will be recommended a pain treatment regimen with over-the-counter medications, acetaminophen or ibuprofen. These patients will be reassured that if their pain is uncontrolled after discharge, a narcotic prescription will be called in to their pharmacy if requested. The investigators will assess patient pain scores and medication use in the recovery area using the electronic medical record. The investigators will collect data on patient pain scores and medication use after discharge on a daily basis via phone call or electronically transmitted survey. The investigators will also evaluate patients at the time of their follow-up visits. Any patient phone calls will be routed to study personnel who will fill narcotic prescription requests if requested. Finally, among patients who do receive an opioid prescription, the investigators will track their opioid consumption.

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 data supports the idea that Opt-In Narcotics Protocol for Breast Surgery is an effective treatment?

The available research shows that using the Opt-In Narcotics Protocol for Breast Surgery can effectively reduce the need for narcotics after surgery. Studies have implemented Enhanced Recovery After Surgery (ERAS) protocols, which focus on reducing opioid use while still managing pain effectively. For example, one study found that using a local anesthetic pump reduced the need for narcotics and helped control pain after breast surgery. Another study showed that an ERAS protocol with preoperative education decreased opioid prescriptions without compromising pain control. These findings suggest that the Opt-In Narcotics Protocol is a successful approach to managing pain with fewer narcotics. ^{1 2 3 4 5}

What safety data exists for the Opt-In Narcotics Protocol for Breast Surgery?

The safety data for the Opt-In Narcotics Protocol for Breast Surgery can be inferred from studies on Enhanced Recovery After Surgery (ERAS) protocols, which focus on reducing narcotic use while maintaining effective pain control. These studies have shown that opioid-sparing techniques can be successfully implemented in breast surgery, reducing the need for narcotics at discharge without compromising pain management. Additionally, the use of local anesthetic pumps has been shown to reduce postoperative pain and narcotic use in breast reconstruction surgery. These findings suggest that the protocol is safe and effective in managing postoperative pain with minimal reliance on narcotics. ^{1 2 3 4 6}

Is the POINT Protocol a promising treatment for pain after breast surgery?

Yes, the POINT Protocol is promising because it aims to reduce the use of narcotics after breast surgery, which can help prevent addiction and other side effects. It focuses on managing pain effectively without relying on strong painkillers, which is important for patient safety and recovery. ^{1 2 7 8 9}

Eligibility Criteria

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Reducing Narcotic Prescriptions in Breast Surgery: A Prospective Analysis. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

A pilot study of a breast surgery Enhanced Recovery After Surgery (ERAS) protocol to eliminate narcotic prescription at discharge. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Decreasing Opioids in Outpatient Breast Surgery with an Enhanced Recovery after Surgery Program and Preoperative Education. [2023]

4. United States 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

How to teach ERAS protocols: surgical residents' perspectives and perioperative practices for breast surgery patients. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

A prospective time-series quality improvement trial of a standardized analgesia protocol to reduce postoperative pain among neurosurgery patients. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Post-operative Nausea and Analgesia Following Total Mastectomy is Improved After Implementation of an Enhanced Recovery Protocol. [2021]

8. England 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Mastectomy is no longer an indication for postoperative opioid prescription at discharge. [2020]