Scheduled or As Needed Pain Regimen?

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Motrin and narcotic

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kaitlyn Benson, DO; Phone Number: 9104853880; Email: KBenson@capefearvalley.com

Study Locations

• United States
  • North Carolina
    • Fayetteville, North Carolina, United States, 28304
      • Recruiting
      • Cape Fear Valley Medical Center
      • Contact: Kaitlyn Benson, DO; Phone Number: 9104853880; Email: KBenson@capefearvalley.com
      • Contact: Kelly Van Fossen, DO; Phone Number: 9104853880

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: scheduled pain regimen; 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.	Drug: Motrin and narcotic; See described earlier
Experimental: as needed pain regimen; 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).	Drug: Motrin and narcotic; See described earlier

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate of effect size pain control	Daily diary of pain (10 point scale)	2 weeks

Collaborators and Investigators

• Sponsor: Cape Fear Valley Health System
• Investigators: Principal Investigator: Kelly Van Fossen, DO, Cape Fear Valley Health

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: surgery; acute pain; post-operative pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Narcotics
• Other Study ID Numbers: 1185-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No