Randomized Prospective Interventional Study: Pain Relief After Laparoscopic Primary Hiatal Hernia Repair
Overview
- Phase
- Phase 4
- Intervention
- Resteck Shiatsu Neck and Back Massager
- Conditions
- Shoulder Pain
- Sponsor
- Norton Thoracic Institute
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Opioid and Non-Opioid Usage Postoperative Period
- Last Updated
- 4 years ago
Overview
Brief Summary
Referred shoulder pain (pain felt when the problem is actually in a different location) is very common after laparoscopic (small, narrow cut) hernia surgery. The purpose of this study is to look at the effect of a simple back massager, which can be readily purchased online or in a store, in addition to the use of standard pain medications.
Investigators
Leslie Munson
Research Program Manager
Norton Thoracic Institute
Eligibility Criteria
Inclusion Criteria
- •Scheduled for primary hiatal hernia repair
- •Adult 18 years of age or older
- •Undergoing minimally invasive surgical technique
Exclusion Criteria
- •Recurrent hiatal hernia
- •Children under the age of 18 years
- •Undergoing open or hybrid surgical technique
- •History of psychiatric disorder or chronic pain
- •Has a post-operative complication (Grade \> I on Calvien Dindo classification)
- •Allergy to standard pain medication regimen (local anesthetics Marcaine, lidocaine, and epinephrine; morphine; oxycodone; Tylenol)
Arms & Interventions
Back Massager Device + Standard Pain Treatment
Resteck Shiatsu Neck and Back Massager (brand name), with recommended use for at least every 2 hours for at least 15 minutes on the first post-operative day and then every 4 hours for 2 days and then as needed. Standard pain treatment: 1. Local anesthetic agent at the incision sites include: 0.5% Marcaine (10 cc) + 0.5% lidocaine and epinephrine (10 cc) (total volume: 20 cc) 2. Morphine 2 mg: Intravenous administration every 2 hours or as needed, if unable to take pills by mouth 3. Oxycodone 5 - 10 mg elixir: oral administration every 6 hours or as needed 4. Tylenol 650 mg Tab: oral administration every 6 hours
Intervention: Resteck Shiatsu Neck and Back Massager
Marcaine spray + Standard Pain Treatment
30cc of 0.25% Marcaine spray on the diaphragm at the end of surgery. Standard pain treatment: 1. Local anesthetic agent at the incision sites include: 0.5% Marcaine (10 cc) + 0.5% lidocaine and epinephrine (10 cc) (total volume: 20 cc) 2. Morphine 2 mg: Intravenous administration every 2 hours or as needed, if unable to take pills by mouth 3. Oxycodone 5 - 10 mg elixir: oral administration every 6 hours or as needed 4. Tylenol 650 mg Tab: oral administration every 6 hours
Intervention: Marcaine
Outcomes
Primary Outcomes
Opioid and Non-Opioid Usage Postoperative Period
Time Frame: 2 years
Subject diary to list any medications taken for pain relief after surgery, and will list the following: name of medication, dose of medication, date and time medication taken
Visual Analogue Score Pain Questionnaire
Time Frame: 2 years
Pain score questionnaire to rate pain on a scale of 0 - 10, with 0 being no pain and 10 being the worst possible pain imaginable. The higher the score, the worse the outcome.