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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
|
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| Marcaine spray + Standard Pain Treatment | Active Comparator | 30cc of 0.25% Marcaine spray on the diaphragm at the end of surgery. Standard pain treatment:
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| 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:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resteck Shiatsu Neck and Back Massager | Device | back massager device sold on the market that can readily be purchased online or in store |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leslie Munson, RN | Contact | 602-406-3825 | Covidresearch@dignityhealth.org | |
| Yadira Gonzales | Contact | 602-406-4000 | Covidresearch@dignityhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Sumeet K Mittal, MD | St. Joseph's Hospital and Medical Center, Norton Thoracic Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital and Medical Center | Recruiting | Phoenix | Arizona | 85013 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40603619 | Derived | 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. |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D006551 | Hernia, Hiatal |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Marcaine | Drug | Marcaine spray at incision site after closure |
|
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D000588 |
| Amines |