Scheduled or As Needed Pain Regimen?

Cape Fear Valley Health System

Status and phase: Enrolling; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Motrin and narcotic

Study type: Interventional

Funder types: Other

Identifiers

NCT06495632

1185-24

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

scheduled pain regimen

Active Comparator group

Description:

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.

Treatment:

Drug: Motrin and narcotic

as needed pain regimen

Experimental group

Description:

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).

Treatment:

Drug: Motrin and narcotic