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

N/ANot Yet RecruitingNCT06737068

Riverside University Health System Medical Center120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

120

Conditions

Hernia, Hiatal Pneumoperitoneum Postoperative Pain Shoulder Pain

Interventions

Low pressure pneumoperitoneum (8-10mmHg) with AirSeal devicePROCEDURE

Elective robot assisted hiatal hernia repair with low pressure pneumoperitoneum (8-10mmHg) with AirSeal device

Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal devicePROCEDURE

Elective robot assisted hiatal hernia repair with standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Riverside University Health System

Moreno Valley, California, United States

Outcomes

Primary Outcomes

Reduction in post-operative shoulder pain

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

Time frame: 1 week (on average)

Secondary Outcomes

Severity of postoperative shoulder pain on POD #0

Severity of postoperative shoulder pain on POD #0 (recorded at nursing shift change \~7PM)

Time frame: 6 hours (on average)

Severity of postoperative shoulder pain on POD #1

Severity of postoperative shoulder pain on POD #1 (when surgical team rounds \~6-8AM)

Time frame: 18 hours (on average)

Severity of postoperative shoulder pain at ~1 week

Severity of postoperative shoulder pain at \~1 week post-operative telephone appointment

Time frame: 1 week (on average)

Severity of postoperative shoulder pain at ~2 weeks post-op

Severity of postoperative shoulder pain at \~2 week postoperative clinic visit measured by numeric pain rating scale and morphine milligram equivalents

Time frame: 2 weeks (on average)

length of hospital stay