Pain With Differing Insufflation Pressures During Laparoscopic Hysterectomy

July 19, 2024 updated by: University of Tennessee
The purpose of this study is to determine the effect of decreased insufflation pressure on postoperative pain, analgesic use, and surgical safety and feasibility for laparoscopic hysterectomy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective, single-blinded, randomized clinical trial in which participants undergoing laparoscopic hysterectomy will be randomized in a 1:1 ratio to undergo surgery with peritoneal insufflation pressure set to 15 mmHg (standard) or 12 mmHg (comparison). Randomization was performed using computer-generated permuted blocks of four participants. All participants on the first postoperative day will be asked to rate their pain with a Visual Analog Scale (VAS). At a postoperative visit 2 weeks after surgery, all participants will be asked to complete the VAS again. The highest preoperative pain (up to 2 hours before surgery) and immediate postoperative pain, using the VAS, in the post anesthesia care unit (PACU) will be recorded. All participants will be planned for discharge from PACU. Age, body mass index, gynecologic diagnosis, medical history, and preoperative analgesia or opioid use will be extracted from the medical records by trained research staff and entered into a secure electronic database. Preoperative analgesia and opioid saw will be verified with active prescription records at the time of surgery. After surgery, analgesic doses, operative time, additional procedures performed, conversion to laparotomy or increased insufflation pressure, estimated blood loss, and length of stay will be recorded.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • University of Tennessee Health Science Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • John O Schorge, MD
        • Sub-Investigator:
          • Emma Ryan, BS
        • Sub-Investigator:
          • Alex Samborski, MD
        • Sub-Investigator:
          • Daniel Amran, BS
        • Sub-Investigator:
          • Jenny Stapel, MD
        • Sub-Investigator:
          • Riley Short, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women aged 18 to 80
  • BMI 55.0 or less
  • Laparoscopic hysterectomy surgery planned

Exclusion Criteria:

  • Women younger than 18 or older than 80 years of age
  • BMI over 55.0
  • Laparoscopic hysterectomy surgery not planned

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 12 mmHg Insufflation Pressure
Participants received 12 mmHg of insufflation pressure during their laparoscopic hysterectomy.
Procedure: Lower Insufflation Pressure
Participants underwent laparoscopic hysterectomy with an insufflation pressure that is lower than the standard insufflation pressure used in this type of surgery.
Active Comparator: 15 mmHg Insufflation Pressure
Participants received 15 mmHg of insufflation pressure during their laparoscopic hysterectomy.
Procedure: Standard Insufflation Pressure
Participants underwent laparoscopic hysterectomy with a standard insufflation pressure.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain on postoperative day 1
Time Frame: 24 hours following surgery
All participants will be asked to rate their pain using the Visual Analog Scale (VAS) approximately 24 hours after surgery completion. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain.
24 hours following surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Opioid use after discharge
Time Frame: Within 2 weeks after surgery
All participants will be asked about the number of prescription opioid pills they took following discharge.
Within 2 weeks after surgery
Preoperative pain
Time Frame: Within 2 hours before surgery
All participants will be asked to rate their pain using the Visual Analog Scale (VAS) upon their arrival before surgery. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain.
Within 2 hours before surgery
Postoperative pain while in PACU
Time Frame: Approximately 2 hours after surgery completion
All participants will be asked to rate their pain using the Visual Analog Scale (VAS) while they are recovering in PACU, approximately 2 hours after surgery completion. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain.
Approximately 2 hours after surgery completion
Postoperative pain at follow-up visit
Time Frame: Approximately 2 weeks after surgery completion
All participants will be asked to rate their pain using the Visual Analog Scale (VAS) at their 2-week postoperative follow-up visit. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain.
Approximately 2 weeks after surgery completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Tennessee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-09977-FB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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