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

December 11, 2024 updated by: Riverside University Health System Medical Center

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Moreno Valley, California, United States, 92555
        • Riverside University Health System
        • Contact:
        • Contact:
          • Marcos Michelotti, MD
        • Contact:
          • Lan-Anh A Nguyen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Pressure Pneumoperitoneum (8-10 mmHg)
Elective robot assisted hiatal hernia repair with pneumoperitoneum pressures of 8-10 mmHg throughout the case
Procedure: Low pressure pneumoperitoneum (8-10mmHg) with AirSeal device
Elective robot assisted hiatal hernia repair with low pressure pneumoperitoneum (8-10mmHg) with AirSeal device
Other Names:
  • low pressure
Other: Standard Pressure Pneumoperitoneum (13-15 mmHg)
Elective robot assisted hiatal hernia repair with pneumoperitoneum pressures of 13-15 mmHg throughout the case
Procedure: Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device
Elective robot assisted hiatal hernia repair with standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device
Other Names:
  • standard pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in post-operative shoulder pain
Time Frame: 1 week (on average)
Percentage reduction in post-operative shoulder pain from POD#0 to ~1 week post-operative telephone appointment
1 week (on average)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riverside University Health System Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2068123-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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