Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06495632

Scheduled or As Needed Regimen? Pilot Study on Multimodal Pain Control and Post-Operative Pain

Led by Cape Fear Valley Health System · Updated on 2025-02-13

90

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the feasibility and effectiveness of two different post-operative pain control methods for adults undergoing same-day outpatient surgeries. The study aims to compare a scheduled pain medication regimen with an as-needed pain regimen to understand their impact on pain control. This pilot feasibility study focuses on common outpatient surgeries performed by a specific surgeon and is sponsored by Cape Fear Valley Health System. Participants will be randomly assigned to one of two groups. One group will follow a fixed schedule of pain medications, including narcotics such as Oxycodone/Acetaminophen, Hydrocodone/Acetaminophen, Hydromorphone, or Tramadol every 4 hours for 2-3 days, plus Motrin 800 mg every 8 hours for 10 days. The other group will take the same medications but only as needed for moderate to severe pain, defined by a numeric pain scale. This study is unblinded and aims to assess the practicality of conducting a larger trial. During the 2-week study period, participants will be monitored for the feasibility of the trial and the effect of the pain control regimens on their pain levels. Researchers will collect data on pain management outcomes and overall participant adherence. Safety and medication use will be tracked to estimate how well each regimen controls post-operative pain. Participants will be followed throughout the two weeks to gather all necessary information on pain control and medication use.

CONDITIONS

Brief Title

Scheduled or As Needed Pain Regimen?

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing any outpatient surgery performed by Dr. Van Fossen at Cape Fear Valley Medical Center during the study
  • Medically eligible to receive the standard post-surgery pain medication protocol
  • Age between 18 and 65 years
Not Eligible

You will not qualify if you...

  • Diagnosis of fibromyalgia, chronic pain, or cancer (except breast cancer)
  • Use of chronic pain medications
  • Not fluent in English
  • Stage 3 Chronic Kidney Disease or higher

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 2 weeks

Participants receive post-operative pain medications including narcotics for 2-3 days every 4 hours and 800 mg Motrin for 10 days every 8 hours either on a fixed schedule or as needed for moderate to severe pain.

1 baseline visit and multiple follow-up visits during treatment

Trial Site Locations

Total: 1 location

1

Cape Fear Valley Medical Center

Fayetteville, North Carolina, United States, 28304

Actively Recruiting

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Research Team

K

Kaitlyn Benson, DO

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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