Low Pressure Pneumoperitoneum for Shoulder Pain After Hiatal Hernia Repair

This study is looking at ways to reduce shoulder pain after robot-assisted hiatal hernia repair surgery. Researchers want to see if using a lower pressure of carbon dioxide to inflate your abdomen during surgery, called low pressure pneumoperitoneum (8-10mmHg) with an AirSeal device, can decrease pain compared to the standard pressure (13-15mmHg) with an AirSeal device. You would undergo standard robot-assisted hiatal hernia repair and may be assigned to either the low or standard pressure group. The main goal is to see if lower pressure reduces shoulder pain about one week after surgery. This study is for adults (18 and older) having elective robot-assisted hiatal hernia repair. The current status of this study is unclear.

Study design
This is an interventional study comparing two different pressure settings during surgery. It plans to enroll 120 participants.
What's involved
You would undergo elective robot-assisted hiatal hernia repair and fill out logs about your pain after surgery. You will also have standard postoperative appointments.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring pain reduction is at 1 week (on average) after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06737068

Low Pressure Pneumoperitoneum Using AirSeal® for Reduction in Postoperative Shoulder Pain Following Robot Assisted Hiatal Hernia Repair

Not Yet Recruiting
NAAges 18+InterventionalPrevention
Riverside University Health System Medical Center
~120 participants
Updated 2024-12-17 on ClinicalTrials.gov
What's tested:Low pressure pneumoperitoneum (8-10mmHg) with AirSeal deviceStandard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Reduction in post-operative shoulder pain
Measured over 1 week (on average)
Hernia, Hiatal
Pneumoperitoneum
Postoperative Pain
Shoulder Pain
1 sites across 1 states
California1
Institutional Review Board Manager
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

patients undergoing elective robot assisted hiatal hernia repair

Exclusion

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
  • Reduction in post-operative shoulder pain1 week (on average)

    Percentage reduction in post-operative shoulder pain from POD#0 to \~1 week post-operative telephone appointment