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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06737068
• Lead Sponsor: Riverside University Health System Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-19
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Study Start: 2025-01-01
• Primary Completion: 2026-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Severity of postoperative shoulder pain on POD #0	6 hours (on average)	Severity of postoperative shoulder pain on POD #0 (recorded at nursing shift change \~7PM)
Severity of postoperative shoulder pain on POD #1	18 hours (on average)	Severity of postoperative shoulder pain on POD #1 (when surgical team rounds \~6-8AM)
Severity of postoperative shoulder pain at ~1 week	1 week (on average)	Severity of postoperative shoulder pain at \~1 week post-operative telephone appointment
Severity of postoperative shoulder pain at ~2 weeks post-op	2 weeks (on average)	Severity of postoperative shoulder pain at \~2 week postoperative clinic visit measured by numeric pain rating scale and morphine milligram equivalents
length of hospital stay	through study completion, an average of 2 years	length of hospital stay
readmission rates for shoulder pain	through study completion, an average of 2 years	readmission rates for chief complaint of shoulder pain
number of postoperative clinic visits related to shoulder pain management	through study completion, an average of 2 years	number of postoperative clinic visits related to shoulder pain management
discharge disposition	through study completion, an average of 2 years	discharge disposition (home, SNF, rehab, etc)
standard vs extended narcotic regimen	through study completion, an average of 2 years	standard vs extended (requiring refill) narcotic regimen
quality of life	1 week (on average)	quality of life assessed via EQ-5D-5L and EQ-VAS questionnaires

Trial Locations

Locations (1)

Riverside University Health System; 🇺🇸 Moreno Valley, California, United States