NCT07221487

Comparing Intra-Abdominal Pressure During Gynecologic Laparoscopy

Low Versus Standard Intra-Abdominal Pressure During Gynecologic Laparoscopy: A Randomized Controlled Trial of Postoperative Pain and Recovery Outcomes

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Nassau University Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if the level of intra-abdominal pressure during benign gynecologic laparoscopic surgery impacts postoperative pain. The main question it aims to answer is: • Does use of low (8 mmHg) versus standard (15 mmHg) intra-abdominal pressure impact postoperative pain? Researchers will compare the use of low (8 mmHg) versus standard (15 mmHg) intra-abdominal pressure. Participants will: * Undergo their regular scheduled gynecologic laparoscopic surgery * Complete pain measures one hour, 3 hours, and 24 hours after surgery

Detailed description

Participants will be randomized into one of two experimental groups using a computer-generated allocation list: a low-pressure group (8 mmHg) or a standard-pressure group (15 mmHg). As part of standard care, many surgeons more often use 15 mmHg which is why this is named as our standard-pressure group. Some surgeons use low-pressure varying from 8 mmHg through 12 mmHg which is why our 8 mmHg is named the low-pressure group. The 8 mmHg is the most common acceptable low-pressure approach reported in the surgical literature. All surgeries will begin with standard insufflation at 15 mmHg to achieve safe abdominal access. Once the operative field is established, if necessary, the pressure will be adjusted according to the assigned group. For those surgeons who use 8 mmHg, standard care is to start at 15 mmHg and then to adjust to the lower pressure of 8 mmHg. Our proposed approach is consistent with standard clinical protocol. General anesthesia will be administered per institutional protocol, and local anesthetic will be applied to all trocar sites.

Conditions

• Gynecologic Surgical Procedures

Interventions

Type	Name	Description
PROCEDURE	abdominal pressure	type of intra-abdominal pressure of either standard or low pressure

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-10-28
• Last updated: 2025-10-29

Locations

1 site across 1 country: United States