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NCT Number: NCT06737068

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

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.

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Key information

Conditions

Hernia, Hiatal Arthralgia Digestive System Diseases Hernia Hernia, Diaphragmatic Internal Hernia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peritoneal Diseases Pneumoperitoneum Postoperative Complications Postoperative Pain Shoulder Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riverside University Health System

Moreno Valley, California, 92555, United States

Location contact

Institutional Review Board Manager

CONTACT

[email protected]

951-486-4452

Lan-Anh A Nguyen, MD

CONTACT

Marcos Michelotti, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

Other names: low pressure

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

Procedure

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

Other names: standard pressure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. length of hospital stay

    Time frame: through study completion, an average of 2 years

    length of hospital stay

  6. readmission rates for shoulder pain

    Time frame: through study completion, an average of 2 years

    readmission rates for chief complaint of shoulder pain

  7. 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

  8. discharge disposition

    Time frame: through study completion, an average of 2 years

    discharge disposition (home, SNF, rehab, etc)

  9. standard vs extended narcotic regimen

    Time frame: through study completion, an average of 2 years

    standard vs extended (requiring refill) narcotic regimen

  10. quality of life

    Time frame: 1 week (on average)

    quality of life assessed via EQ-5D-5L and EQ-VAS questionnaires

Sponsors and collaborators

Lead sponsor

Riverside University Health System Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 17, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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