Pain With Differing Insufflation Pressures During Laparoscopic Hysterectomy

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
University of Tennessee
Study ID
NCT06508814
Status
Recruiting
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Conditions

  • Post Operative Pain

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Lower Insufflation Pressure — PROCEDURE
    Participants underwent laparoscopic hysterectomy with an insufflation pressure that is lower than the standard insufflation pressure used in this type of surgery.
  • Standard Insufflation Pressure — PROCEDURE
    Participants underwent laparoscopic hysterectomy with a standard insufflation pressure.

Study Details

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.

Key Dates

Start date
Jun 10, 2024
Status verified
Jul 2024
Primary completion
Jun 10, 2025
Completion
Jun 10, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 12 mmHg Insufflation Pressure
    Participants received 12 mmHg of insufflation pressure during their laparoscopic hysterectomy.
  • Active Comparator: 15 mmHg Insufflation Pressure
    Participants received 15 mmHg of insufflation pressure during their laparoscopic hysterectomy.

Primary Outcome Measure

Pain on postoperative day 1 [ Time Frame: 24 hours following surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Tennessee Health Science CenterMemphisTennessee38103
Amira Wohabrebbi, PhD
[email protected]
901-545-7453
Annette Hickerson, RN
[email protected]
901-448-4784
John O Schorge, MD (PRINCIPAL_INVESTIGATOR)
Emma Ryan, BS (SUB_INVESTIGATOR)
Alex Samborski, MD (SUB_INVESTIGATOR)
Daniel Amran, BS (SUB_INVESTIGATOR)
Jenny Stapel, MD (SUB_INVESTIGATOR)
Riley Short, MD (SUB_INVESTIGATOR)

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By research site
University of Tennessee Health Science Center· Memphis, TN

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