Pain Relief After Hiatal Hernia Repair Surgery

Norton Thoracic Institute

Status and phase: Unknown; Phase 4

Conditions: Shoulder Pain; Hiatal Hernia

Treatments: Drug: Marcaine; Device: Resteck Shiatsu Neck and Back Massager

Study type: Interventional

Funder types: Other

Identifiers

NCT04936711

PHX-21-500-157-50-18

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Back Massager Device + Standard Pain Treatment

Experimental group

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: 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

Treatment:

Device: Resteck Shiatsu Neck and Back Massager

Marcaine spray + Standard Pain Treatment

Active Comparator group

Description:

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

Treatment:

Drug: Marcaine

Standard Pain Treatment

No Intervention group

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: 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