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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using lower pressure to inflate the abdomen during robot-assisted hiatal hernia surgery can reduce postoperative shoulder pain. Participants will have their abdomen inflated either with lower pressure using the AirSeal device or at standard pressure during the procedure. The trial seeks to decrease pain, reduce related costs, and cut down on clinic and emergency visits. It is open to individuals scheduled for elective robot-assisted hiatal hernia repair who do not have conditions like chronic pain or a BMI over 40. As an unphased trial, it offers participants the opportunity to contribute to innovative surgical techniques that could improve patient outcomes.

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 prior data suggests that low pressure pneumoperitoneum with the AirSeal device is safe?

Research has shown that using the AirSeal device for low-pressure surgery is generally safe. Studies have found that this method carries a risk of complications similar to standard pressure techniques. Patients using the AirSeal device often report less shoulder pain after surgery, with lower pain levels at 4, 8, and 24 hours post-procedure. This suggests that the treatment is well-tolerated. Overall, the available evidence indicates that this technique is safe and may help reduce post-surgery pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using low pressure pneumoperitoneum with the AirSeal device because it aims to reduce postoperative shoulder pain, a common discomfort following laparoscopic surgeries. Unlike traditional methods that use standard pressure pneumoperitoneum (13-15 mmHg), this approach lowers the pressure to 8-10 mmHg. This lower pressure may lessen the strain on the diaphragm and nerves, potentially leading to less shoulder pain after surgery. By using the AirSeal device, this technique also promises to maintain a stable surgical environment, which is crucial for effective and safe operations.

What evidence suggests that low pressure pneumoperitoneum is effective for reducing postoperative shoulder pain?

This trial will compare low-pressure pneumoperitoneum with standard pressure pneumoperitoneum during elective robot-assisted hiatal hernia repair. Studies have suggested that low-pressure techniques with the AirSeal device during keyhole surgeries may reduce postoperative pain. Patients reported less pain, particularly between 5 and 12 hours after surgery, and experienced fewer complications overall. Lower pressure might also enable earlier hospital discharge. This method likely reduces discomfort by decreasing abdominal pressure, which can lessen irritation and shoulder pain after surgery. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06737068

Low Pressure Pneumoperitoneum Using AirSeal® for ... The goal of this clinical trial is to evaluate the incidence and severity of post-operative shoulder pain following elective robot-assisted hiatal hernia ...

2. withpower.com withpower.com/trial/phase-shoulder-pain-2025-4c78c

Low Pressure Pneumoperitoneum for Postoperative ... Some studies suggest that using the AirSeal device for low-pressure pneumoperitoneum during laparoscopic surgery may reduce postoperative pain, as two out of ...

3. trial.medpath.com trial.medpath.com/clinical-trial/3dbc1d4c5ea71a04/nct06737068-low-pressure-pneumoperitoneum-shoulder-pain-reduction

Low Pressure Pneumoperitoneum Using AirSeal® for ... The goal of this clinical trial is to evaluate the incidence and severity of post-operative shoulder pain following elective robot-assisted hiatal hernia ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12287184/

Shoulder pain after laparoscopic antireflux surgery Post-laparoscopic shoulder pain (PLSP) is a significant source of postoperative morbidity after hiatal hernia repair and antireflux surgery.

5. conmed.com conmed.com/en/products/airseal-and-insufflation/airseal-data

AirSeal Clinical Study Appendix Patients had lower max pain scores between 5 and 12 hours; Fewer overall complications; The mean LOS was shorter (0.57 vs 1 day); 43.3% of patients were ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4848341/

What is the evidence for the use of low-pressure ... Quality assessment showed that the overall quality of evidence was moderate to low. Postoperative pain scores were reduced by the use of low-pressure ...