Comparing scheduled versus as needed pain management after surgery

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

This study is testing whether giving pain medication on a schedule or only when needed helps people feel better after same-day surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Cape Fear Valley Health System (Academic / other)
• Locations: 1 site (Fayetteville, North Carolina)
• Trial ID: NCT06495632 on ClinicalTrials.gov

What this trial studies

This study aims to assess the feasibility of a randomized controlled trial comparing the effectiveness of a scheduled pain management regimen against an as-needed approach for patients undergoing same-day surgical procedures. Participants will receive either Motrin or narcotics based on the assigned regimen to evaluate pain control outcomes. The study will focus on various outpatient surgeries performed at Cape Fear Valley Medical Center, providing insights into optimal pain management strategies post-surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 undergoing specific outpatient surgeries at Cape Fear Valley Medical Center.

Not a fit: Patients with chronic pain conditions or those undergoing surgeries not included in the study criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management protocols for postoperative patients, enhancing recovery experiences.

How similar studies have performed: While there have been studies on pain management regimens, this specific comparison of scheduled versus as-needed approaches in outpatient settings is relatively novel.

Eligibility criteria

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.

Where this trial is running

Fayetteville, North Carolina

• Cape Fear Valley Medical Center — Fayetteville, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Kelly Van Fossen, DO — Cape Fear Valley Health
• Study coordinator: Kaitlyn Benson, DO

Conditions Pain, Postoperative; surgery; acute pain; post-operative pain