Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06495632

Scheduled or As Needed Pain Regimen?

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cape Fear Valley Medical Center

Fayetteville, North Carolina, 28304, United States

Location status: Recruiting

Location contact

Kaitlyn Benson, DO

CONTACT

[email protected]

9104853880

Kelly Van Fossen, DO

CONTACT

9104853880

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Motrin and narcotic

Drug

See described earlier

Primary outcomes

  1. Feasibility of trial

    Time frame: 2 weeks

    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.

Secondary outcomes

  1. Estimate of effect size pain control

    Time frame: 2 weeks

    Daily diary of pain (10 point scale)

Study contacts

Contact information is provided by the study sponsor or research team.

Kaitlyn Benson, DO

CONTACT

[email protected]

9104853880

Sponsors and collaborators

Lead sponsor

Cape Fear Valley Health System

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 11, 2024
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.