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Pain Relief After Hiatal Hernia Repair Surgery

Primary Purpose

Shoulder Pain, Hiatal Hernia

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Resteck Shiatsu Neck and Back Massager
Marcaine
Sponsored by
Norton Thoracic Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Shoulder pain, Hernia, Hernia surgery, Hernia repair, Hiatal hernia, Hiatal hernia surgery, Hiatal hernia repair, Post surgery pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • St. Joseph's Hospital and Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Back Massager Device + Standard Pain Treatment

Marcaine spray + Standard Pain Treatment

Standard Pain Treatment

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
May 19, 2021
Last Updated
June 21, 2021
Sponsor
Norton Thoracic Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04936711
Brief Title
Pain Relief After Hiatal Hernia Repair Surgery
Official Title
Randomized Prospective Interventional Study: Pain Relief After Laparoscopic Primary Hiatal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Norton Thoracic Institute

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Hiatal Hernia
Keywords
Shoulder pain, Hernia, Hernia surgery, Hernia repair, Hiatal hernia, Hiatal hernia surgery, Hiatal hernia repair, Post surgery pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Back Massager Device + Standard Pain Treatment
Arm Type
Experimental
Arm Description
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
Arm Title
Marcaine spray + Standard Pain Treatment
Arm Type
Active Comparator
Arm Description
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
Arm Title
Standard Pain Treatment
Arm Type
No Intervention
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Resteck Shiatsu Neck and Back Massager
Intervention Description
back massager device sold on the market that can readily be purchased online or in store
Intervention Type
Drug
Intervention Name(s)
Marcaine
Other Intervention Name(s)
bupivacaine hydrochloride
Intervention Description
Marcaine spray at incision site after closure
Primary Outcome Measure Information:
Title
Visual Analogue Score Pain Questionnaire
Description
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.
Time Frame
2 years
Title
Opioid and Non-Opioid Usage Postoperative Period
Description
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
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leslie Munson, RN
Phone
602-406-3825
Email
Covidresearch@dignityhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Yadira Gonzales
Phone
602-406-4000
Email
Covidresearch@dignityhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumeet K Mittal, MD
Organizational Affiliation
St. Joseph's Hospital and Medical Center, Norton Thoracic Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Munson, RN
Phone
602-406-3825
Email
Covidresearch@dignityhealth.org
First Name & Middle Initial & Last Name & Degree
Sumeet K Mittal, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pain Relief After Hiatal Hernia Repair Surgery

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