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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Gynecologic Surgical Procedures
• Intervention / Treatment: Procedure: abdominal pressure

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.

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Petr Itzhak, DO; Phone Number: 516-296-7394; Email: pitzhak@numc.edu

Study Locations

• United States
  • New York
    • East Meadow, New York, United States, 11554
      • Nassau University Medical Center
      • Contact: Petr Itzhak; Phone Number: 516-296-7394; Email: pitzhak@numc.edu
      • Principal Investigator: Petr Itzhak, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard-pressure group; 15 mmHg pressure	Procedure: abdominal pressure; type of intra-abdominal pressure of either standard or low pressure
Experimental: low-pressure group; 8 mmHg	Procedure: abdominal pressure; type of intra-abdominal pressure of either standard or low pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PAIN OUT questionnaire	Self-report questionnaire to patient participants focusing on shoulder pain with a total composite score from 12 items. Minimum score is 0 and maximum score is 120. Higher scores indicate greater pain levels.	Perioperative/Periprocedural: Three hours after surgery completed

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PAIN OUT questionnaire	Self-report questionnaire to patient participants focusing on shoulder pain with a total composite score from 12 items. Minimum score is 0 and maximum score is 120. Higher scores indicate greater pain levels.	Perioperative/Periprocedural: 24 hours after surgery completed
Numerical rating scale for pain location in the abdomen	One item to patient participants to rate the abdominal pain from 0 (no pain) to 10 (worst pain)	Perioperative/Periprocedural: One hour after surgery
Numerical rating scale for pain location in the shoulder	One item to patient participants to rate the shoulder pain from 0 (no pain) to 10 (worst pain)	Perioperative/Periprocedural: One hour after surgery
Visual analog scale for pain location in the abdomen	One item to patient participants to rate the abdominal pain from 0 (no pain) to 10 (worst pain)	Perioperative/Periprocedural: Three hours after surgery completed
Visual analog scale for pain location in the abdomen	One item to patient participants to rate the abdominal pain from 0 (no pain) to 10 (worst pain)	Perioperative/Periprocedural: 24 hours after surgery completed
Length of hospital stay	Length of hospital stay for the patient participants after surgery completed measured in minutes. Longer stay defined as greater number of minutes	Perioperative/Periprocedural
Complications	Presence of nausea or vomiting after surgery in patient participants. Yes responses indicate the presence of complications	Perioperative/Periprocedural
Hospital Readmission	Hospital readmission to patient participants within 30 days after surgery completed. Yes indicates a hospital readmission	Perioperative/Periprocedural
Use of non-medicine methods to relieve pain	Provided a checklist to patient participants of non-medicine choices such as cold pack, meditation, prayer, massage, distraction like watching television. A yes to any of these choices indicates use of non-medicine methods to relieve pain	Perioperative/Periprocedural
Overall Quality of Surgical Visual Field	Question to the surgeon with choices rating the overall surgical conditions throughout the procedure from extremely poor with a choice of 1 to optimal with a choice of 5. Higher scores indicate a better overall quality of surgical visual field	Perioperative/Periprocedural

Collaborators and Investigators

• Sponsor: Nassau University Medical Center
• Investigators: Principal Investigator: Petr Itzhak, DO, Nassau University Medical Center

Publications and helpful links

General Publications

• Reijnders-Boerboom GTJA, Albers KI, Jacobs LMC, Helden EV, Rosman C, Diaz-Cambronero O, Mazzinari G, Scheffer GJ, Keijzer C, Warle MC. Low intra-abdominal pressure in laparoscopic surgery: a systematic review and meta-analysis. Int J Surg. 2023 May 1;109(5):1400-1411. doi: 10.1097/JS9.0000000000000289.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: October 24, 2025
• First Submitted That Met QC Criteria: October 24, 2025
• First Posted (Estimated): October 28, 2025

Study Record Updates

• Last Update Posted (Estimated): October 29, 2025
• Last Update Submitted That Met QC Criteria: October 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: pain; abdominal pressure
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Therapeutics; Decompression; Lower Body Negative Pressure
• Other Study ID Numbers: 25-300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentfied data based upon a reasonable request
• IPD Sharing Time Frame: After study using data is published
• IPD Sharing Access Criteria: Academic researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No