Low Pressure Pneumoperitoneum Using AirSeal® for Reduction in Postoperative Shoulder Pain Following Robot Assisted Hiatal Hernia Repair: a Prospective Randomized Controlled Trial.

NCT06737068 NA NOT_YET_RECRUITING

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.

Details

Lead sponsor	Riverside University Health System Medical Center
Phase	NA
Status	NOT_YET_RECRUITING
Enrolment	120
Start date	2025-01-01
Completion	2027-01

Conditions

• Hernia, Hiatal
• Pneumoperitoneum
• Postoperative Pain
• Shoulder Pain

Interventions

• Low pressure pneumoperitoneum (8-10mmHg) with AirSeal device
• Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device

Primary outcomes

• Reduction in post-operative shoulder pain — 1 week (on average)
  Percentage reduction in post-operative shoulder pain from POD#0 to \~1 week post-operative telephone appointment

Countries

United States