Insufflation Pressure for Postoperative Pain

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Tennessee

Disqualifiers: Age, Bmi, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using lower insufflation pressure (the pressure used to inflate the abdomen during surgery) can reduce pain and the need for pain medication after a laparoscopic hysterectomy. It compares two pressure levels: 12 mmHg and 15 mmHg. Women planning to undergo this surgery with a BMI of 55 or less might be suitable candidates. The study also assesses the safety and feasibility of performing the surgery with lower pressure. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance surgical outcomes and patient comfort.

Do I need to stop 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 lower insufflation pressure is safe for laparoscopic hysterectomy?

Research has shown that using lower air pressure during laparoscopic hysterectomy might be safe and beneficial for patients. Studies have found that surgeries performed with lower pressure (usually 10 mmHg or less) often result in less postoperative pain and shorter hospital stays. Patients tend to recover more comfortably and quickly.

However, lower pressure can sometimes make it harder for surgeons to see clearly during the operation. Despite this, the reduced pain after surgery remains a consistent benefit.

Patients generally handle lower air pressure well, with fewer reports of negative effects compared to standard pressure. This makes it a promising option for those seeking to reduce postoperative pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether using lower insufflation pressure during laparoscopic hysterectomy can reduce postoperative pain. Typically, insufflation pressure during such surgeries is set at 15 mmHg. This trial is investigating the effects of reducing that pressure to 12 mmHg. The potential benefit of this approach is enhanced patient comfort and reduced recovery time without compromising the surgical outcome, which could be a game-changer for patient care in laparoscopic procedures.

What evidence suggests that lower insufflation pressure is effective for reducing postoperative pain?

This trial will compare the effects of different insufflation pressures on postoperative pain. Research has shown that using lower air pressure during surgery might help reduce pain afterward. Some studies found that surgeries performed with lower pressure, around 10 mmHg, are linked to less pain and a shorter hospital stay. One study noted a small but noticeable drop in pain on a standard 10-point scale. Additionally, using lower pressure might reduce the need for pain medication after surgery. Overall, these findings suggest that lower air pressure could make recovery more comfortable. Participants in this trial will receive either 12 mmHg or 15 mmHg of insufflation pressure during their laparoscopic hysterectomy to evaluate these effects. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals undergoing laparoscopic hysterectomy, a minimally invasive surgery to remove the uterus. Participants must meet certain health criteria set by the researchers but these specific requirements are not provided in the given information.

Inclusion Criteria

BMI 55.0 or less

I am scheduled for a laparoscopic hysterectomy.

I am a woman aged between 18 and 80.

Exclusion Criteria

I am not planning to have a laparoscopic hysterectomy.

I am a woman aged between 18 and 80.

My BMI is over 55.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Participants' preoperative pain is assessed using the Visual Analog Scale (VAS) within 2 hours before surgery

1 day

1 visit (in-person)

Treatment

Participants undergo laparoscopic hysterectomy with either 12 mmHg or 15 mmHg insufflation pressure

1 day

1 visit (in-person)

Immediate Postoperative

Participants' pain is assessed using the VAS in the post anesthesia care unit (PACU) approximately 2 hours after surgery

2 hours

Postoperative Day 1

Participants' pain is assessed using the VAS approximately 24 hours after surgery

1 day

Follow-up

Participants are monitored for postoperative pain and opioid use at a follow-up visit 2 weeks after surgery

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Lower Insufflation Pressure

Trial Overview The study is testing two different levels of gas pressure used during surgery: standard insufflation pressure versus lower insufflation pressure. The goal is to see which one results in less pain after surgery and how they affect safety and use of painkillers.

How Is the Trial Designed?

Group I: 12 mmHg Insufflation Pressure Experimental Treatment 1 Intervention

Participants received 12 mmHg of insufflation pressure during their laparoscopic hysterectomy.

Group II: 15 mmHg Insufflation Pressure Active Control 1 Intervention

Participants received 15 mmHg of insufflation pressure during their laparoscopic hysterectomy.

Lower Insufflation Pressure is already approved in United States, European Union for the following indications:

Approved in United States as Low-pressure pneumoperitoneum for:

• Laparoscopic hysterectomy
• Laparoscopic cholecystectomy
• Laparoscopic colorectal surgery

Approved in European Union as Low-pressure pneumoperitoneum for:

• Laparoscopic hysterectomy
• Laparoscopic cholecystectomy
• Laparoscopic colorectal surgery

Who Is Running the Clinical Trial?

University of Tennessee

Lead Sponsor

Trials

202

Recruited

146,000+

Published Research Related to This Trial

In a study of 598 patients undergoing robotic gynecologic surgery, decreasing insufflation pressure significantly reduced postoperative pain scores and hospital length of stay, with lower pressures correlating to less pain (3.8 at 8 mmHg vs 5.9 at 15 mmHg).

Lower insufflation pressures (≤ 10 mmHg) did not increase surgical duration or blood loss, making this a safe and effective strategy to enhance patient recovery and comfort during robotic surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Less is more: clinical impact of decreasing pneumoperitoneum pressures during robotic surgery. Foley, CE., Ryan, E., Huang, JQ.[2021]

In a study of 40 patients undergoing laparoscopic cholecystectomy, using a lower insufflation pressure of 8 mm Hg did not show any benefits in reducing tissue trauma, postoperative pain, or recovery compared to the standard pressure of 15 mm Hg.

Both groups experienced similar levels of postoperative pain, analgesic use, and complications, indicating that lowering the pressure during laparoscopic surgery may not improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized comparison between different insufflation pressures for laparoscopic cholecystectomy. Perrakis, E., Vezakis, A., Velimezis, G., et al.[2019]

In a study of 100 patients undergoing laparoscopic cholecystectomy, those operated on with low-pressure pneumoperitoneum (8-10 mmHg) reported significantly lower post-operative pain scores compared to those at standard pressure (12-14 mmHg).

The low-pressure technique also showed improved outcomes in eight out of ten inflammatory markers, suggesting a potential reduction in inflammation, although these results were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of low-pressure pneumoperitoneum on pain and inflammation in laparoscopic cholecystectomy: a randomized controlled clinical trial. Rashdan, M., Daradkeh, S., Al-Ghazawi, M., et al.[2023]

In a study of 80 patients undergoing laparoscopic cholecystectomy, low-pressure pneumoperitoneum (10 mm Hg) did not improve the overall quality of recovery compared to standard-pressure pneumoperitoneum (14 mm Hg), as assessed by the QoR-40 questionnaire.

Patients in the low-pressure group reported more pain during forced coughing in the hours following surgery, indicating that lower pressure may not be beneficial for post-operative comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of recovery in patients under low- or standard-pressure pneumoperitoneum. A randomised controlled trial. Moro, ET., Pinto, PCC., Neto, AJMM., et al.[2021]

In a study of 76 patients undergoing transperitoneal laparoscopic urologic surgeries, lower intraperitoneal insufflation pressures (10 mmHg) resulted in significantly reduced postoperative pain scores at 6 and 12 hours compared to higher pressures (12 mmHg and 14 mmHg).

The findings suggest that using lower insufflation pressures can lead to better pain management in the early postoperative period, although there was no significant difference in pain scores at 24 hours post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which intraperitoneal insufflation pressure should be used for less postoperative pain in transperitoneal laparoscopic urologic surgeries? Akkoc, A., Topaktas, R., Aydin, C., et al.[2018]

This study aims to determine if using a lower pneumoperitoneum pressure of 8 mm Hg with deep neuromuscular blockade results in less postoperative pain compared to a pressure of 12 mm Hg with moderate blockade, involving 300 patients undergoing pelvic surgery.

The trial will assess not only pain levels but also factors like surgeon satisfaction, respiratory stability, and costs, providing comprehensive data on the effectiveness and practicality of this anesthesia approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Deep Versus Moderate Neuromuscular Blockade in Laparoscopic Gynecologic Surgery on Postoperative Pain and Surgical Conditions: Protocol for a Randomized Controlled Trial. De Robertis, E., Caprino Miceli, A., Colombo, GL., et al.[2020]

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® Insufflation System During Laparoscopic Surgery: A Systematic Review. Balayssac, D., Selvy, M., Martelin, A., et al.[2021]

Citations

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

Impact of pneumoperitoneum pressure during laparoscopic ... Current studies investigating lower pneumoperitoneum pressure in gynecologic surgery suggest a minimal decrease in postoperative pain without a significant ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36434823/

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

3. aagl.confex.com aagl.confex.com/aagl/2020/mediafile/Handout/Session1597/KHuang_CFoley_JRS.pdf

clinical impact of decreasing pneumoperitoneum pressures ... Surgery performed at lower-pressure pneumoperitoneum (≤ 10 mmHg) is associated with lower postoperative pain scores, shorter length of stay, and improved ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4769697/

Low vs Standard Pressures in Gynecologic Laparoscopy We found a statistically significant but modest diminution in postoperative pain of 0.38 standardized unit based on an original 10-point scale (95% confidence ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02853591

Comparison of Pneumoinsufflation Modes and Pressure ... This is a randomized-controlled double-blinded trial examining outcomes from total laparoscopic hysterectomies performed under low and high pressure ...