RECRUITING

Scheduled or As Needed Pain Regimen?

Conditions

Pain, Postoperative surgery acute pain post-operative pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-08-01

Study Completion:2027-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06495632

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Kaitlyn Benson, DO

CONTACT

9104853880

KBenson@capefearvalley.com

Principal Investigator

Kelly Van Fossen, DO

PRINCIPAL_INVESTIGATOR

Cape Fear Valley Health

Study Locations (Sites)

Cape Fear Valley Medical Center

Fayetteville, North Carolina, 28304

United States

Collaborators and Investigators

Sponsor: Cape Fear Valley Health System

Kelly Van Fossen, DO, PRINCIPAL_INVESTIGATOR, Cape Fear Valley Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01

Study Completion Date2027-07-31

Study Record Updates

Study Start Date2024-08-01

Study Completion Date2027-07-31

Terms related to this study

Keywords Provided by Researchers

surgery
acute pain
post-operative pain

Additional Relevant MeSH Terms

Pain, Postoperative