Comparing Intra-Abdominal Pressure During Gynecologic Laparoscopy

Nassau University Medical Center

Status: Not yet enrolling

Conditions: Gynecologic Surgical Procedures

Treatments: Procedure: abdominal pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT07221487

25-300

Details and patient eligibility

About

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

Full 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.

Enrollment: 190 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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190 participants in 2 patient groups

standard-pressure group

Active Comparator group

Description:

15 mmHg pressure

Treatment:

Procedure: abdominal pressure

low-pressure group

Experimental group

Description:

8 mmHg

Treatment:

Procedure: abdominal pressure