Recruiting

Pain Relief

Sponsor:

Norton Thoracic Institute

Code:

NCT04936711

Conditions

Shoulder Pain

Hiatal Hernia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Resteck Shiatsu Neck and Back Massager

Marcaine

Study Details

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.

Conditions

Shoulder Pain

Hiatal Hernia

Study ID

NCT04936711

Start date

May 12, 2021

Status verified date

Jun, 2021

Completion date

Nov 30, 2022

Anticipated

Primary completion date

Nov 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

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

Interventions

Resteck Shiatsu Neck and Back Massager

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

Marcaine

Marcaine spray at incision site after closure

Primary outcome measure

  • Visual Analogue Score Pain Questionnaire [ Time Frame: 2 years ]
  • Opioid and Non-Opioid Usage Postoperative Period [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Leslie Munson, RN

602-406-3825Covidresearch@dignityhealth.org

Yadira Gonzales

602-406-4000Covidresearch@dignityhealth.org

Locations

St. Joseph's Hospital and Medical Center

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Leslie Munson, RN

602-406-3825Covidresearch@dignityhealth.org

Principal Investigator:

Sumeet K Mittal, MD

More Information

Sponsor

Norton Thoracic Institute

Last update posted

Jun 23, 2021

Last verified

Jun, 2021

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Norton Thoracic Institute on 2021-06-23.