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Clinical Trials/NCT06508814
NCT06508814RecruitingNot Applicable

Pain With Differing Insufflation Pressures During Laparoscopic Hysterectomy

University of Tennessee2 sites in 1 country100 target enrollmentStarted: June 10, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
100
Locations
2
Primary Endpoint
Pain on postoperative day 1

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Preoperative pain(Within 2 hours before surgery)
  • Postoperative pain while in PACU(Approximately 2 hours after surgery completion)
  • Opioid use after discharge(Within 2 weeks after surgery)
  • Postoperative pain at follow-up visit(Approximately 2 weeks after surgery completion)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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