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NCT04936711 Clinical Trial

Pain Relief After Hiatal Hernia Repair Surgery

Shoulder Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04936711
Other study ID # PHX-21-500-157-50-18
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date May 12, 2021
Est. completion date November 30, 2022

Study information
Verified date June 2021
Source Norton Thoracic Institute
Contact Leslie Munson, RN
Phone 602-406-3825
Email Covidresearch@dignityhealth.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date November 30, 2022
Est. primary completion date November 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Resteck Shiatsu Neck and Back Massager
back massager device sold on the market that can readily be purchased online or in store
Drug:
• Marcaine
Marcaine spray at incision site after closure

Locations
Country Name City State
United States St. Joseph's Hospital and Medical Center Phoenix Arizona

Sponsors (1)
Lead Sponsor Collaborator
Norton Thoracic Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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