Low vs Standard Pressure for Postoperative Pain

(LOw PRESSuRE Trial)

Overseen By Sara Hojabri, MBBCHBAO

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mount Sinai Hospital, Canada

Disqualifiers: Previous laparotomy, Cancer, Chronic pain, Endometriosis, Fibromyalgia, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

82 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether lower pressure during laparoscopic surgery (low-pressure pneumoperitoneum) can reduce postoperative pain. It focuses on women undergoing certain gynecologic surgeries, such as ovary or cyst removal. Participants will experience either the usual pressure or a lower pressure during their procedure. The study aims to determine if lower pressure results in less pain during recovery. This trial may suit women without chronic pain or advanced gynecological cancer who plan to undergo the specified surgeries. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance surgical recovery for future patients.

Do I have to stop taking my current medications for the 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 this method is safe for postoperative pain management?

Research has shown that using lower pressure during laparoscopic surgeries can be safe and well-tolerated. One study comparing low and standard pressures found no major differences in complications during surgery, blood loss, or postoperative issues between the two groups. This suggests that lower pressure does not increase the risk of problems.

Additionally, a review of 26 studies involving over 2,000 patients found that low-pressure surgeries often resulted in less postoperative pain. No serious safety concerns were associated with the low-pressure method.

This evidence supports the idea that using lower pressure during surgery might be a safe option and could help reduce pain after the procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the low pressure pneumoperitoneum technique because it promises to reduce postoperative pain compared to the standard laparoscopic procedure. Most laparoscopies are performed using standard pressure (15 mm Hg), which can contribute to discomfort after surgery. By lowering the pressure to 10 mm Hg, this technique may lessen the strain on the body, potentially leading to a more comfortable recovery and less need for pain medication. This innovative approach could significantly improve patient outcomes and satisfaction after surgery.

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

This trial will compare the effects of low-pressure pneumoperitoneum with standard pressure during laparoscopy on postoperative pain. Research has shown that using lower air pressure during surgery can reduce pain afterward. One study found that patients experienced less pain while resting with lower pressure. Another study demonstrated that using very low pressure, such as 4 mmHg, reduced shoulder pain after surgery. This method also decreased the need for pain medication. Overall, lower pressure during surgeries may help patients recover more comfortably. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals undergoing certain benign gynecologic surgeries, such as removal of ovaries or ovarian cysts. Participants must understand and sign the consent form, be able to follow study procedures, and have the capacity to provide informed consent.

Inclusion Criteria

Participant must sign and date the informed consent form

I am 18 years old or older.

I understand the details of the clinical trial and can make decisions about my care.

Exclusion Criteria

I experience chronic pain.

My gynecological cancer is stage 2 or beyond.

Language barrier

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants undergo laparoscopic gynecologic surgery with either low or standard pressure pneumoperitoneum

1 day

1 visit (in-person)

Post-operative Monitoring

Post-operative pain, nausea, and medication use are assessed in the PACU. Patients are contacted on POD1 to assess post-operative pain scores and adverse events.

1 day

1 visit (in-person), 1 follow-up call

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of pain and recovery scores

1 day

1 follow-up call

What Are the Treatments Tested in This Trial?

Interventions

• Low Pressure Pneumoperitoneum

Trial Overview The study compares low (10 mm Hg) versus standard pressure (15 mm Hg) pneumoperitoneum during laparoscopic surgery. It's a double-blind trial where patients are randomly assigned to either control (standard pressure) or intervention (low pressure).

How Is the Trial Designed?

Group I: Low Pressure Experimental Treatment 1 Intervention

Patients undergoing experimental intervention of low pressure pneumoperitoneum (10 mm Hg)

Group II: Standard Pressure Active Control 1 Intervention

Patients undergoing laparosocpy at standard pressure (15 mm Hg)

Who Is Running the Clinical Trial?

Mount Sinai Hospital, Canada

Lead Sponsor

Trials

210

Recruited

70,700+

Women's College Hospital

Collaborator

Trials

108

Recruited

43,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12408282/

Low pneumoperitoneum pressure facilitates postoperative ... Our findings suggest that LPP in laparoscopic gastrointestinal surgery significantly reduces postoperative pain at rest (SMD = -0.40, 95% CI: - ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1015958422008181

The effectiveness of extremely low-pressure ... This study demonstrated that reducing the pressure of the pneumoperitoneum to 4 mmHg could lower the incidence of postoperative shoulder pain and this extremely ...

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

What is the evidence for the use of low-pressure ... Postoperative pain scores were reduced by the use of low-pressure pneumoperitoneum. With appropriate perioperative measures, the use of low-pressure ...

4. ls.amegroups.org ls.amegroups.org/article/view/8244/html

Low-pressure pneumoperitoneum—why and how - Rosenberg Recent evidence suggests that low-pressure pneumoperitoneum may offer advantages in terms of reduced postoperative pain, analgesic consumption, and shoulder ...

5. bmcsurg.biomedcentral.com bmcsurg.biomedcentral.com/articles/10.1186/s12893-024-02606-w

a double blinded randomized clinical trial | BMC Surgery Previous studies have reported that low-pressure laparoscopic cholecystectomy (LPLC) might decrease postoperative pain [8,9,10].

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211522005966

Impact of pneumoperitoneum pressure during laparoscopic ... Current data suggests that reduced pneumoperitoneum insufflation pressure during laparoscopic surgery may impact postoperative pain. Given the current ...

7. academic.oup.com academic.oup.com/gastro/article/doi/10.1093/gastro/goae052/7717317

Low-pressure versus standard-pressure pneumoperitoneum ... Secondary outcomes related to safety including intraoperative complications, blood loss, postoperative complications, and major complications.

8. journals.lww.com journals.lww.com/surgical-laparoscopy/fulltext/2025/04000/the_impact_of_intraoperative_co2_pneumoperitoneum.12.aspx

The Impact of Intraoperative CO 2 Pneumoperitoneum ... Out of 26 articles meeting inclusion criteria, encompassing 2077 patients, 15 demonstrated positive associations with low-pressure pneumoperitoneum. No ...