Clinical trial NCT06737068: Low Pressure Pneumoperitoneum Using AirSeal® for Reduction in Postoperative Shoulder Pain Following Robot Assisted Hiatal Hernia Repair
Official title: Low Pressure Pneumoperitoneum Using AirSeal® for Reduction in Postoperative Shoulder Pain Following Robot Assisted Hiatal Hernia Repair: a Prospective Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hernia, Hiatal
Pneumoperitoneum
Postoperative Pain
Shoulder Pain
Lead sponsor: Riverside University Health System Medical Center
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to evaluate the incidence and severity of post-operative shoulder pain following elective robot-assisted hiatal hernia repair in hopes of reducing pain and associated costs as well as clinic and emergency department visits due to this pain. You will undergo standard robot-assisted hiatal hernia repair with the standard postoperative care. The only difference is that you may be selected for the group where lower pressures used to fill your abdomen with carbon dioxide will be used, and you will be asked to fill out logs regarding your pain postoperatively. You will have postoperative appointments that are standard following this procedure.


Eligibility criteria: Inclusion Criteria:

* patients undergoing elective robot assisted hiatal hernia repair

Exclusion Criteria:

* patients less than 18 years of age
* conversion to open surgery
* BMI \> 40
* history of abdominoplasty
* history of chronic pain and/or opioid dependence
* history of COPD and/or supplemental oxygen use
* pregnant patients
* incarcerated patients
* patient refusal

Primary outcomes:
measure: Reduction in post-operative shoulder pain
timeFrame: 1 week (on average)
Secondary outcomes:
measure: Severity of postoperative shoulder pain on POD #0
timeFrame: 6 hours (on average)
measure: Severity of postoperative shoulder pain on POD #1
timeFrame: 18 hours (on average)
measure: Severity of postoperative shoulder pain at ~1 week
timeFrame: 1 week (on average)
measure: Severity of postoperative shoulder pain at ~2 weeks post-op
timeFrame: 2 weeks (on average)
measure: length of hospital stay
timeFrame: through study completion, an average of 2 years
measure: readmission rates for shoulder pain
timeFrame: through study completion, an average of 2 years
measure: number of postoperative clinic visits related to shoulder pain management
timeFrame: through study completion, an average of 2 years
measure: discharge disposition
timeFrame: through study completion, an average of 2 years
measure: standard vs extended narcotic regimen
timeFrame: through study completion, an average of 2 years
measure: quality of life
timeFrame: 1 week (on average)
Other outcomes:
Locations:
city: Moreno Valley
country: United States
facility: Riverside University Health System
state: California
Study officials:
References:
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