Pain Relief After Hiatal Hernia Repair Surgery

June 21, 2021 updated by: Leslie Munson, Norton Thoracic Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • St. Joseph's Hospital and Medical Center
        • Contact:
        • Principal Investigator:
          • Sumeet K Mittal, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: Resteck Shiatsu Neck and Back Massager
back massager device sold on the market that can readily be purchased online or in store
Active Comparator: 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
Drug: Marcaine
Marcaine spray at incision site after closure
Other Names:
  • bupivacaine hydrochloride
No Intervention: Standard Pain Treatment

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:

  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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norton Thoracic Institute

Investigators

  • Principal Investigator: Sumeet K Mittal, MD, St. Joseph's Hospital and Medical Center, Norton Thoracic Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2021

Primary Completion (Anticipated)

November 30, 2021

Study Completion (Anticipated)

November 30, 2022

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

June 23, 2021

Last Update Submitted That Met QC Criteria

June 21, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHX-21-500-157-50-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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