Low Pressure Pneumoperitoneum for Postoperative Shoulder Pain

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Riverside University Health System Medical Center

Disqualifiers: Age < 18, BMI > 40, Chronic pain, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

120 Participants Needed

Trial Summary

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Low pressure pneumoperitoneum with AirSeal device for reducing postoperative shoulder pain?

Some studies suggest that using the AirSeal device for low-pressure pneumoperitoneum during laparoscopic surgery may reduce postoperative pain, as two out of three studies showed a significant decrease in pain. However, results are inconsistent, and more research is needed to confirm these findings. ^{1 2 3 4 5}

Is low pressure pneumoperitoneum with the AirSeal device safe for humans?

Research shows that using the AirSeal device for low-pressure pneumoperitoneum in surgeries is generally safe, with similar complication rates compared to standard methods. However, more studies are needed to fully understand its benefits and preferences among patients and doctors. ^{1 2 3 4 5}

How does the low pressure pneumoperitoneum with AirSeal device treatment differ from other treatments for postoperative shoulder pain?

The low pressure pneumoperitoneum with AirSeal device is unique because it uses a special system to maintain low pressure during laparoscopic surgery, which can reduce postoperative shoulder pain by minimizing the amount of gas left in the body. This approach is different from standard methods that use higher pressure, potentially leading to more discomfort after surgery. ^{1 2 4 6 7}

What is the purpose of this 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.

Eligibility Criteria

This trial is for individuals undergoing elective robot-assisted hiatal hernia repair. Participants must be suitable for the surgery and willing to log their postoperative pain. Specific inclusion or exclusion criteria are not provided, but typically these would relate to overall health status and any conditions that might interfere with the study.

Inclusion Criteria

I am scheduled for a robotic-assisted surgery to repair a hiatal hernia.

Exclusion Criteria

I have a history of chronic pain or have been dependent on opioids.

Pregnant patients

My surgery was changed to an open procedure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo standard robot-assisted hiatal hernia repair with either low or standard pressure pneumoperitoneum

1 day

1 visit (in-person)

Postoperative Monitoring

Participants' postoperative shoulder pain is monitored, including severity assessments on POD #0, POD #1, and at 1 and 2 weeks post-op

2 weeks

1 visit (in-person), 1 visit (telephone)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including readmission rates and quality of life assessments

2 years

Treatment Details

Interventions

• Low pressure pneumoperitoneum with AirSeal device

Trial Overview The trial is testing two different pressures used during surgery: a lower pressure (8-10mmHg) versus a standard pressure (13-15mmHg), both using the AirSeal device. The aim is to see if lower pressure reduces post-operative shoulder pain.

Participant Groups

Group I: Standard Pressure Pneumoperitoneum (13-15 mmHg) Experimental Treatment 1 Intervention

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

Group II: Low Pressure Pneumoperitoneum (8-10 mmHg) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Riverside University Health System Medical Center

Lead Sponsor

Trials

10

Recruited

19,300+

Findings from Research

The AIRSEAL® insufflation device is feasible for use in laparoscopic surgery, with a total of 1394 participants across 10 studies showing similar complication rates compared to standard CO2 insufflators.

While some studies indicated a potential reduction in post-operative pain and shorter operative duration with AIRSEAL®, the results were inconsistent, highlighting the need for further research to confirm its clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and Organizational Impact of the AIRSEAL&#174; Insufflation System During Laparoscopic Surgery: A Systematic Review. Balayssac, D., Selvy, M., Martelin, A., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical and Organizational Impact of the AIRSEAL&#174; Insufflation System During Laparoscopic Surgery: A Systematic Review. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Prospective randomized trial of low-pressure pneumoperitoneum for reduction of shoulder-tip pain following laparoscopy. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A Prospective, Observational Trial Assessing the Efficacy of Abdominal Compression in Reducing Laparoscopic-Induced Shoulder Pain. [2018]

4. Ireland pubmed.ncbi.nlm.nih.gov

The impact of a pulmonary recruitment maneuver to reduce post-laparoscopic shoulder pain: A randomized controlled trial. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Low Pressure Robot-assisted Radical Prostatectomy With the AirSeal System at OLV Hospital: Results From a Prospective Study. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Randomized comparison between low-pressure laparoscopic cholecystectomy and gasless laparoscopic cholecystectomy. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Prevention of postlaparoscopic shoulder pain by forced evacuation of residual CO(2). [2021]