Pain Relief After Hiatal Hernia Repair Surgery

Phase 4

• Conditions: Hiatal Hernia; Shoulder Pain
• Interventions: Device: Resteck Shiatsu Neck and Back Massager; Drug: Marcaine

• Registration Number: NCT04936711
• Lead Sponsor: Norton Thoracic Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-12
• Study First Submitted: 2021-05-19
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-21
• Last Update Submitted: 2021-06-21
• Study First Posted: 2021-06-23
• Last Update Posted: 2021-06-23
• Primary Completion: 2021-11-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Back Massager Device + Standard Pain Treatment	Resteck Shiatsu Neck and Back Massager	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
Marcaine spray + Standard Pain Treatment	Marcaine	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

Primary Outcome Measures

Name	Time	Method
Opioid and Non-Opioid Usage Postoperative Period	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	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.

Trial Locations

Locations (1)

St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States