Low Pressure Pneumoperitoneum for Postoperative Shoulder Pain

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Riverside University Health System Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for individuals undergoing elective robot-assisted hiatal hernia repair. Participants must be suitable for the surgery and willing to log their postoperative pain. Specific inclusion or exclusion criteria are not provided, but typically these would relate to overall health status and any conditions that might interfere with the study.

Inclusion Criteria

I am scheduled for a robotic-assisted surgery to repair a hiatal hernia.

Exclusion Criteria

I have a history of chronic pain or have been dependent on opioids.

Pregnant patients

My surgery was changed to an open procedure.

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Treatment Details

Interventions

Low pressure pneumoperitoneum with AirSeal device (Procedure)

Trial OverviewThe trial is testing two different pressures used during surgery: a lower pressure (8-10mmHg) versus a standard pressure (13-15mmHg), both using the AirSeal device. The aim is to see if lower pressure reduces post-operative shoulder pain.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Standard Pressure Pneumoperitoneum (13-15 mmHg)Experimental Treatment1 Intervention

Elective robot assisted hiatal hernia repair with pneumoperitoneum pressures of 13-15 mmHg throughout the case

Group II: Low Pressure Pneumoperitoneum (8-10 mmHg)Experimental Treatment1 Intervention

Elective robot assisted hiatal hernia repair with pneumoperitoneum pressures of 8-10 mmHg throughout the case