Pain Relief After Hiatal Hernia Repair Surgery

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04936711

Enrollment

Registered

2021-06-23

Start date

2021-05-12

Completion date

2022-11-30

Last updated

2021-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain, Hiatal Hernia

Keywords

Shoulder pain, Hernia, Hernia surgery, Hernia repair, Hiatal hernia, Hiatal hernia surgery, Hiatal hernia repair, Post surgery pain

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.

Interventions

DEVICEResteck Shiatsu Neck and Back Massager

back massager device sold on the market that can readily be purchased online or in store

DRUGMarcaine

Marcaine spray at incision site after closure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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.
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

Countries

United States

Contacts

Primary ContactLeslie Munson, RN

Covidresearch@dignityhealth.org602-406-3825

Backup ContactYadira Gonzales

Covidresearch@dignityhealth.org602-406-4000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026