Low vs Standard Pressure for Postoperative Pain
(LOw PRESSuRE Trial)
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.12345Why 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.13678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo laparoscopic gynecologic surgery with either low or standard pressure pneumoperitoneum
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of pain and recovery scores
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?
2
Treatment groups
Experimental Treatment
Active Control
Patients undergoing experimental intervention of low pressure pneumoperitoneum (10 mm Hg)
Patients undergoing laparosocpy at standard pressure (15 mm Hg)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mount Sinai Hospital, Canada
Lead Sponsor
Women's College Hospital
Collaborator
Citations
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: - ...
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 ...
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 ...
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 ...
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].
Impact of pneumoperitoneum pressure during laparoscopic ...
Current data suggests that reduced pneumoperitoneum insufflation pressure during laparoscopic surgery may impact postoperative pain. Given the current ...
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.aspxThe 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 ...
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