Pain Relief After Hiatal Hernia Repair Surgery

NCT04936711 | Unknown Phase 4 FDA Drug

• 1 other identifier: PHX-21-500-157-50-18
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Back Massager Device + Standard Pain Treatment

EXPERIMENTAL

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

Marcaine spray + Standard Pain Treatment

ACTIVE COMPARATOR

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

Standard Pain Treatment

NO INTERVENTION

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 DEVICE

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

Back Massager Device + Standard Pain Treatment

Marcaine DRUG

Marcaine spray at incision site after closure

Also known as: bupivacaine hydrochloride

Marcaine spray + Standard Pain Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for primary hiatal hernia repair
• Adult 18 years of age or older
• Undergoing minimally invasive surgical technique

You may not qualify if:

• 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)

Sponsors & Collaborators

• Norton Thoracic Institute: lead

Study Sites (1)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

RECRUITING

Related Publications (1)

• Mittal SK, Latorre-Rodriguez AR, Bremner RM. Shoulder pain after laparoscopic antireflux surgery: a single-center, randomized, open-label trial. Surg Endosc. 2025 Aug;39(8):5355-5366. doi: 10.1007/s00464-025-11939-3. Epub 2025 Jul 2.

  PMID: 40603619 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Hernia, Hiatal; Hernia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hernia, Diaphragmatic; Internal Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sumeet K Mittal, MD

  St. Joseph's Hospital and Medical Center, Norton Thoracic Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie Munson, RN

CONTACT

602-406-3825; Covidresearch@dignityhealth.org

Yadira Gonzales

CONTACT

602-406-4000; Covidresearch@dignityhealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Program Manager

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: June 23, 2021
• Study Start: May 12, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2022
• Last Updated: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)