Pain With Differing Insufflation Pressures During Laparoscopic Hysterectomy

Last updated: July 19, 2024
Sponsor: University of Tennessee
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Lower Insufflation Pressure

Standard Insufflation Pressure

Clinical Study ID

NCT06508814
24-09977-FB
  • Ages 18-80
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women aged 18 to 80

  • BMI 55.0 or less

  • Laparoscopic hysterectomy surgery planned

Exclusion

Exclusion Criteria:

  • Women younger than 18 or older than 80 years of age

  • BMI over 55.0

  • Laparoscopic hysterectomy surgery not planned

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Lower Insufflation Pressure
Phase:
Study Start date:
June 10, 2024
Estimated Completion Date:
June 10, 2025

Study 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.

Connect with a study center

  • University of Tennessee Health Science Center

    Memphis, Tennessee 38103
    United States

    Active - Recruiting

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