Recruiting

Pain Regimen

Sponsor:

Cape Fear Valley Health System

Code:

NCT06495632

Conditions

Pain, Postoperative

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Motrin and narcotic

Study Details

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 participants undergoing same day surgery procedures.

Conditions

Pain, Postoperative

Study ID

NCT06495632

Start date

Aug 1, 2024

Status verified date

Feb, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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).

Interventions

Motrin and narcotic

See described earlier

Primary outcome measure

  • Feasibility of trial [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Kaitlyn Benson, DO

9104853880KBenson@capefearvalley.com

Locations

Cape Fear Valley Medical Center

Recruiting

Fayetteville, North Carolina, United States, 28304

Contacts

Kaitlyn Benson, DO

9104853880KBenson@capefearvalley.com

Kelly Van Fossen, DO

9104853880

More Information

Sponsor

Cape Fear Valley Health System

Last update posted

Feb 13, 2025

Last verified

Feb, 2025

Keywords

  • surgery
  • acute pain
  • post-operative pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cape Fear Valley Health System on 2025-02-13.