Pain, PostoperativePhase 4NCT06495632
Scheduled or as Needed Pain Regimen?
A Phase 4 study testing Motrin and narcotic in people with Pain, Postoperative, run by Cape Fear Valley Health System at 1 site in United States.
Trial summary
The aim of this study is to determine feasibility of a randomized controlled trial and estimates of efficacy for pain control of a scheduled pain regimen versus an as needed pain regimen for participants undergoing same day surgery procedures. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Motrin and narcotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 31 Jul 2027
- Phase
- Phase 4
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any outpatient surgeries performed at Cape Fear Valley Medical Center by Dr. Van Fossen during the duration of the study, including: laparoscopic cholecystectomy, laparoscopic appendectomy, laparoscopic ventral/umbilical/incisional hernia repair, open ventral/umbilical/incisional hernia repair, laparoscopic inguinal hernia repair, open inguinal hernia repair, lumpectomy, sentinel lymph node biopsy, lymph node biopsy, mass excision skin or subcutaneous, diagnostic laparoscopy, laparoscopic lysis of adhesions, pilonidal cyst excision, hemorrhoidectomy, anal fissure/sphincterotomy, anal fistulectomy, rectal exam under anesthesia, wound debridement, and wound closure
- Outpatients who are medically eligible to receive the standard post surgery medication protocol (the scheduled pain protocol used in this study).
- Age 18-65
Who cannot join
- Participants with the following conditions will be excluded from our study: fibromyalgia, chronic pain, cancer (except for breast cancer). This is because these participants have pain at baseline and it will be difficult to discern if their pain is from surgery or their chronic condition.
- Participants on chronic pain medications will also be excluded from our study because it will be difficult to tell if their pain control is related to their established regimen or the one we are implementing.
- If participants who are not fluent in English, because all study materials are in English.
- Participants with stage 3 Chronic Kidney Disease or higher will also be excluded from the study as they cannot take ibuprofen (according to National Kidney Foundation), which is included in our pain regimen.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cape Fear Valley Medical Center
Fayetteville, North Carolina, 28304
About this study
Official title: Scheduled or as Needed Regimen? A Pilot Feasibility Study on Multimodal Pain Control and Post-Operative Pain
The aim of this study is to determine feasibility of a randomized controlled trial and estimates of efficacy for pain control of a scheduled pain regimen versus an as needed pain regimen for participants undergoing same day surgery procedures.
- Conditions
- Pain, Postoperative
- Being tested
- Motrin and narcotic
- Keywords
- surgery, acute pain, post-operative pain
- Medical subject headings
- Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motrin and narcoticDrug
See described earlier
| Study group | Role | What they receive |
|---|---|---|
| scheduled pain regimen | Active comparator | This group will receive post-operative pain medications including narcotics for 2-3 days (Oxycodone/Acetaminophen 5mg/325mg, Hydrocodone/Acetaminophen 5mg/325mg, Hydromorphone 2mg, or Tramadol 50mg) every 4 hours and 800 mg Motrin for 10 days every 8 hours on a fixed time/day schedule. Receives: Drug: Motrin and narcotic |
| as needed pain regimen | Experimental | This group will receive post-operative pain medications including narcotics for 2-3 days (Oxycodone/Acetaminophen 5mg/325mg, Hydrocodone/Acetaminophen 5mg/325mg, Hydromorphone 2mg, or Tramadol 50mg) every 4 hours and 800 mg Motrin for 10 days every 8 hours as needed for moderate to severe pain (4-10 on numeric rating scale). Receives: Drug: Motrin and narcotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of trial
To measure feasibility of the study, the following data will be collected:
- Number of participants eligible for the study
- Number of participants contacted about the study
- Number of participants consented
- Number of participants being at least 80% adherent to medication protocol
- Number of drop-outs in the study and reason for drop out
- Number of Adverse Events reported to study personnel. For all non-consented participants, only counts will be included (e.g., 5 participants who refused to consent), no identifying or private information will be collected.
Measured: 2 weeks
Secondary outcomes (1)
Estimate of effect size pain control
Daily diary of pain (10 point scale)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Aug 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cape Fear Valley Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelly Van Fossen, DO, Principal investigator, Cape Fear Valley Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495632
- Sponsor's protocol ID
- 1185-24
- Status last verified
- Oct 2026
- First submitted
- 2 Jul 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No