Recruiting

Observational Study

Sponsor:

University of Tennessee

Code:

NCT06508814

Conditions

Post Operative Pain

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Lower Insufflation Pressure

Standard Insufflation Pressure

Study Details

Brief summary:

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.

Conditions

Post Operative Pain

Study ID

NCT06508814

Start date

Jun 10, 2024

Status verified date

Jul, 2024

Completion date

Jun 10, 2025

Anticipated

Primary completion date

Jun 10, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Standard Insufflation Pressure

Participants underwent laparoscopic hysterectomy with a standard insufflation pressure.

Primary outcome measure

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

Central Contacts and Locations

Locations

University of Tennessee Health Science Center

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Amira Wohabrebbi, PhD

901-545-7453awohabre@uthsc.edu

Annette Hickerson, RN

901-448-4784abpayne@uthsc.edu

Principal Investigator:

John O Schorge, MD

More Information

Sponsor

University of Tennessee

Last update posted

Jul 23, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Tennessee on 2024-07-23.