90 Participants Needed

Scheduled vs As-Needed Pain Medication for Postoperative Pain

KB
Overseen ByKaitlyn Benson, DO
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Cape Fear Valley Health System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to manage pain after same-day surgeries by comparing two approaches: taking pain medication on a fixed schedule or only when needed. The trial aims to determine which method more effectively controls pain using medications like Motrin (a nonsteroidal anti-inflammatory drug) and narcotics (a class of pain-relieving drugs). Individuals undergoing specific outpatient surgeries and not experiencing chronic pain conditions might be suitable candidates. As a Phase 4 trial, this research involves FDA-approved treatments and helps determine how they benefit more patients.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but if you are on chronic pain medications, you cannot participate in the study.

What is the safety track record for these treatments?

Research has shown that both regular and as-needed pain medications are generally safe for managing post-surgery pain. Studies have found that narcotics, such as Oxycodone and Hydrocodone, and Motrin, a type of ibuprofen, effectively reduce pain after surgery.

Taking medication on a regular schedule can provide consistent pain relief, which might help some patients feel more comfortable. Conversely, taking medication only when needed allows patients to use it solely when they experience pain, reducing the risk of unnecessary drug use.

Narcotics can sometimes cause side effects like nausea or dizziness, while Motrin may upset the stomach. Most patients tolerate these medications well, but discussing any concerns with a healthcare provider before starting treatment is advisable.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it compares two approaches to managing postoperative pain: a scheduled regimen versus an as-needed regimen. Unlike the standard practice of administering pain medications in a fixed schedule, the as-needed approach tailors medication intake to the patient's actual pain levels, potentially minimizing unnecessary drug use and reducing side effects. This approach could lead to a more personalized pain management strategy, ensuring patients receive relief when they need it while avoiding overmedication. By evaluating these methods, the trial aims to optimize pain management, improve patient comfort, and enhance recovery experiences after surgery.

What evidence suggests that this trial's treatments could be effective for postoperative pain?

This trial will compare two approaches to managing postoperative pain: a scheduled pain regimen and an as-needed pain regimen. Studies have shown that following a set schedule for taking pain medication can manage pain after surgery more consistently. This method involves taking regular doses of medications like narcotics and Motrin, which can keep pain levels steady and might reduce the need for higher doses later. Alternatively, taking medication only when pain occurs allows for a more personalized approach. Research indicates that using nonsteroidal anti-inflammatory drugs (NSAIDs) like Motrin before and after surgery may lower pain levels and reduce the need for opioids. Both methods aim to control pain effectively, offering different benefits depending on how pain is managed over time.14678

Who Is on the Research Team?

KV

Kelly Van Fossen, DO

Principal Investigator

Cape Fear Valley Health

Are You a Good Fit for This Trial?

This trial is for individuals who are experiencing pain after same-day surgery procedures. The study will include those willing to follow a scheduled or as-needed pain medication regimen.

Inclusion Criteria

I am an outpatient and can take standard post-surgery medications.
I will have outpatient surgery by Dr. Van Fossen at Cape Fear Valley Medical Center.

Exclusion Criteria

I am not fluent in English.
My kidney function is moderately to severely reduced.
I am on long-term pain medication.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive post-operative pain medications including narcotics for 2-3 days and Motrin for 10 days

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Motrin and Narcotic
Trial Overview The study is testing the effectiveness of two pain management strategies: one where patients take Motrin and narcotics on a fixed schedule, and another where they take these medications only when they feel it's necessary.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: as needed pain regimenExperimental Treatment1 Intervention
Group II: scheduled pain regimenActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cape Fear Valley Health System

Lead Sponsor

Trials
2
Recruited
220+

Citations

Postoperative Pain Control - StatPearls - NCBI BookshelfPostoperative pain control aims to reduce the negative consequences of acute postsurgical pain and help the patient transition smoothly back to normal function.
Clinical practice guidelines for postoperative pain ...The use of NSAIDs as a preemptive analgesic before surgery can reduce postoperative pain intensity and opioid consumption, as well as the incidence of adverse ...
Evaluation of Factors Relevant to Pain Control Among ...This decision analytical model study uses survey responses to investigate the importance patients gave to attributes of postoperative pain ...
Comparing Analgesic Regimen Effectiveness and Safety after ...The primary effectiveness outcome is patient-reported worst daily pain intensity over the first 7 days after surgery. The primary safety outcome ...
Postoperative pain management in non-traumatic emergency ...A case–control cohort study of 1231 patients undergoing gynecologic and abdominal surgery showed that ibuprofen and acetaminophen (600 mg every ...
CDC Clinical Practice Guideline for Prescribing Opioids ...This guideline provides recommendations for clinicians providing pain care, including those prescribing opioids, for outpatients aged ≥18 years.
Efficacy and Safety of Scheduled Dosing of Opioid ...Scheduled dosing of opioids is believed to provide more effective analgesia when compared to as needed (PRN) administration of the drug.
Pharmacologic Therapy for Acute PainThis article provides a tiered pharmacologic approach for safe and effective management of acute pain in ambulatory and inpatient settings (Table 1). Most data ...
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