Shoulder PainPhase 4NCT04936711
Pain Relief After Hiatal Hernia Repair Surgery
A Phase 4 study testing Resteck Shiatsu Neck and Back Massager and Marcaine in people with Shoulder Pain and Hiatal Hernia, run by Norton Thoracic Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain, Hiatal Hernia
- What is being tested?
- Resteck Shiatsu Neck and Back Massager and Marcaine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2021to 30 Nov 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for primary hiatal hernia repair
- Adult 18 years of age or older
- Undergoing minimally invasive surgical technique
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Leslie Munson, RN, 602-406-3825, Covidresearch@dignityhealth.org
Sumeet K Mittal, MD
About this study
Official title: 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.
- Conditions
- Shoulder Pain, Hiatal Hernia
- Being tested
- Resteck Shiatsu Neck and Back Massager, Marcaine
- Keywords
- Shoulder pain, Hernia, Hernia surgery, Hernia repair, Hiatal hernia, Hiatal hernia surgery, Hiatal hernia repair, Post surgery pain
- Medical subject headings
- Shoulder Pain, Hernia, Hiatal, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resteck Shiatsu Neck and Back MassagerDevice
back massager device sold on the market that can readily be purchased online or in store
MarcaineDrug
Also called bupivacaine hydrochloride
Marcaine spray at incision site after closure
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start12 May 2021
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norton Thoracic Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie Munson, Norton Thoracic Institute
- Investigators
- Sumeet K Mittal, MD, Principal investigator, St. Joseph's Hospital and Medical Center, Norton Thoracic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936711
- Sponsor's protocol ID
- PHX-21-500-157-50-18
- Status last verified
- Jun 2021
- First submitted
- 19 May 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40603619
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Interventional Study: Pain Relief After Laparoscopic Primary Hiatal Hernia Repair
- ClinicalTrials.gov ID
- NCT04936711
- Acronym / sponsor ID
- PHX-21-500-157-50-18
- Conditions
- Shoulder Pain, Hiatal Hernia
- Keywords
- Shoulder pain, Hernia, Hernia surgery, Hernia repair, Hiatal hernia, Hiatal hernia surgery, Hiatal hernia repair, Post surgery pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Norton Thoracic InstituteUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Back Massager Device + Standard Pain Treatment | Experimental | Device: Resteck Shiatsu Neck and Back MassagerResteck 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 |
| Marcaine spray + Standard Pain Treatment | Active comparator | Drug: Marcaine30cc 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 |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled for primary hiatal hernia repair
- Adult 18 years of age or older
- Undergoing minimally invasive surgical technique
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resteck Shiatsu Neck and Back Massagerback massager device sold on the market that can readily be purchased online or in store | Device | Back Massager Device + Standard Pain Treatment |
| MarcaineAlso: bupivacaine hydrochlorideMarcaine spray at incision site after closure | Drug | Marcaine spray + Standard Pain Treatment |
Primary outcome
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Derived from this study: PubMed 40603619Mittal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sumeet K Mittal, MD principal investigator
St. Joseph's Hospital and Medical Center, Norton Thoracic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Resteck Shiatsu Neck and Back Massager and Marcaine in people with Shoulder Pain and Hiatal Hernia, run by Norton Thoracic Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leslie Munson, RN (602-406-3825, Covidresearch@dignityhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Score Pain Questionnaire (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04936711, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.