Pain Relief After Hiatal Hernia Repair Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Prospective Interventional Study: Pain Relief After Laparoscopic Primary Hiatal Hernia Repair

Conditions
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Shoulder Pain, Hiatal Hernia

Intervention / Treatment
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* Device: Resteck Shiatsu Neck and Back Massager
* Drug: Marcaine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Back Massager Device + Standard Pain Treatment<br>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: Local anesthetic agent at the incision sites include: 0.5% Marcaine (10 cc) + 0.5% lidocaine and epinephrine (10 cc) (total volume: 20 cc) Morphine 2 mg: Intravenous administration every 2 hours or as needed, if unable to take pills by mouth Oxycodone 5 - 10 mg elixir: oral administration every 6 hours or as needed Tylenol 650 mg Tab: oral administration every 6 hours | Device: Resteck Shiatsu Neck and Back Massager<br>* back massager device sold on the market that can readily be purchased online or in store<br>|
| Active Comparator: Marcaine spray + Standard Pain Treatment<br>30cc of 0.25% Marcaine spray on the diaphragm at the end of surgery. Standard pain treatment: Local anesthetic agent at the incision sites include: 0.5% Marcaine (10 cc) + 0.5% lidocaine and epinephrine (10 cc) (total volume: 20 cc) Morphine 2 mg: Intravenous administration every 2 hours or as needed, if unable to take pills by mouth Oxycodone 5 - 10 mg elixir: oral administration every 6 hours or as needed Tylenol 650 mg Tab: oral administration every 6 hours | Drug: Marcaine<br>* Marcaine spray at incision site after closure<br>* Other names: bupivacaine hydrochloride;|
| No Intervention: Standard Pain Treatment<br>will receive standard pain treatment include local anesthetic agent at the incision sites + oral Tylenol and oral or IV opioid as breakthrough pain treatment postoperatively as needed. Standard pain treatment: Local anesthetic agent at the incision sites include: 0.5% Marcaine (10 cc) + 0.5% lidocaine and epinephrine (10 cc) (total volume: 20 cc) Morphine 2 mg: Intravenous administration every 2 hours or as needed, if unable to take pills by mouth Oxycodone 5 - 10 mg elixir: oral administration every 6 hours or as needed Tylenol 650 mg Tab: oral administration every 6 hours | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Score Pain Questionnaire | 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. | 2 years | 
| Opioid and Non-Opioid Usage Postoperative Period | 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 | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder pain, Hernia, Hernia surgery, Hernia repair, Hiatal hernia, Hiatal hernia surgery, Hiatal hernia repair, Post surgery pain