Status:
RECRUITING
Scheduled or As Needed Pain Regimen?
Lead Sponsor:
Cape Fear Valley Health System
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 participa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06495632
Start Date
August 1 2024
End Date
July 31 2027
Last Update
February 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cape Fear Valley Medical Center
Fayetteville, North Carolina, United States, 28304