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

Riverside University Health System Medical Center

Status: Not yet enrolling

Conditions: Postoperative Pain; Shoulder Pain; Pneumoperitoneum; Hernia, Hiatal

Treatments: Procedure: Low pressure pneumoperitoneum (8-10mmHg) with AirSeal device; Procedure: Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device

Study type: Interventional

Funder types: Other

Identifiers

NCT06737068

2068123-1

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Low Pressure Pneumoperitoneum (8-10 mmHg)

Experimental group

Description:

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

Treatment:

Procedure: Low pressure pneumoperitoneum (8-10mmHg) with AirSeal device

Standard Pressure Pneumoperitoneum (13-15 mmHg)

Other group

Description:

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

Treatment:

Procedure: Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device