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

Trial Summary

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 data supports the effectiveness of the treatment Lower Insufflation Pressure for reducing postoperative pain?

Research shows that using lower insufflation pressure during surgeries, like robotic gynecologic surgery, is linked to less postoperative pain and shorter hospital stays. This suggests that lower pressure can be a simple and effective way to improve recovery after surgery. ^{1 2 3 4 5}

Is low insufflation pressure safe for humans during surgery?

Research shows that using lower insufflation pressure during surgery is generally safe for humans. Studies found no increase in complications, and it may even reduce pain and improve breathing during surgery. ^{3 4 5 6 7}

How does the treatment of lower insufflation pressure differ from other treatments for postoperative pain?

Lower insufflation pressure, used during surgeries like laparoscopic procedures, is unique because it reduces the pressure of the gas used to inflate the abdomen, which can lead to less postoperative pain and shorter hospital stays without increasing surgery time or blood loss. This approach is a simple, low-cost intervention that improves patient comfort and recovery. ^{1 3 4 5 6}

What is the purpose of this trial?

The purpose of this study is to determine the effect of decreased insufflation pressure on postoperative pain, analgesic use, and surgical safety and feasibility for laparoscopic hysterectomy.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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]

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]

References

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

Randomized comparison between different insufflation pressures for laparoscopic cholecystectomy. [2019]

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

Quality of recovery in patients under low- or standard-pressure pneumoperitoneum. A randomised controlled trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Effect of low-pressure pneumoperitoneum on pain and inflammation in laparoscopic cholecystectomy: a randomized controlled clinical trial. [2023]

4. Brazil pubmed.ncbi.nlm.nih.gov

Which intraperitoneal insufflation pressure should be used for less postoperative pain in transperitoneal laparoscopic urologic surgeries? [2018]

5. England pubmed.ncbi.nlm.nih.gov

Less is more: clinical impact of decreasing pneumoperitoneum pressures during robotic surgery. [2021]

6. Canada 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. [2020]

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

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