Low Versus Standard Intra-Abdominal Pressure During Gynecologic Laparoscopy: A Randomized Controlled Trial of Postoperative Pain and Recovery Outcomes
| Registry | NCT07221487 |
|---|---|
| Status | Terminated - The hospital closed down the Obstetrics and Gynecology department. Patients relevant to the study are no longer available to recruit. |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 37 (Actual) |
| Sponsor | Nassau University Medical Center (Other) |
| Conditions | Gynecologic Surgical Procedures |
| Interventions | abdominal pressure (Procedure) |
| Dates | start 2025-11-23, primary completion 2026-07-21, completion 2026-07-21, first posted 2025-10-28, last updated 2026-07-22 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Gynecologic Surgical Procedures All trials of abdominal pressure
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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| standard-pressure group | Active comparator | Procedure: abdominal pressure | 15 mmHg pressure |
| low-pressure group | Experimental | Procedure: abdominal pressure | 8 mmHg |
Sex: Female, ages: 18 Years to any
Inclusion Criteria: * Undergoing benign gynecologic laparoscopic surgery with eligible procedures, including the following. * Salpingectomy * Cystectomy * Oophorectomy * Myomectomy * Hysterectomy. * Only those who speak English or Spanish will be recruited, as our validated questionnaires are only available in those languages. Exclusion Criteria: * Participants with the following diseases will be excluded due to their diseases having pain that may strongly interfere with their perception of pain in the area of surgery. * Arthritis * Gout * Metastatic cancer * Pelvic floor disease * Headache disorders * Herpes zoster or shingles * Frozen shoulder * Complex regional pain syndrome (CRPS) * Slipped disc * Sickle cell disease * Sciatica * Trigeminal neuralgia * Fibromyalgia.
| Facility | City | Country | Status |
|---|---|---|---|
| Nassau University Medical Center | East Meadow, New York | United States |