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Comparing Intra-Abdominal Pressure During Gynecologic Laparoscopy

ConditionGynecologic Surgical Procedures
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNassau University Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Undergoing benign gynecologic laparoscopic surgery with eligible procedures, including the following.

Salpingectomy

Cystectomy

Oophorectomy

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • abdominal pressure

    Procedure/Surgery

    type of intra-abdominal pressure of either standard or low pressure

Treatment groups

190 Participants
are divided into 2 treatment groups
Group A: standard-pressure groupActive comparator 1 intervention
Group B: low-pressure groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Perioperative/Periprocedural: Three hours after surgery completed

Secondary outcomes

1

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.

Time frame
Perioperative/Periprocedural: 24 hours after surgery completed
2

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)

Time frame
Perioperative/Periprocedural: One hour after surgery
3

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)

Time frame
Perioperative/Periprocedural: One hour after surgery
4

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)

Time frame
Perioperative/Periprocedural: Three hours after surgery completed

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nassau University Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: