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Insufflation Pressure for Postoperative Pain
N/A
Recruiting
Research Sponsored by University of Tennessee
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Laparoscopic hysterectomy surgery planned
Be older than 18 years old
Must not have
Laparoscopic hysterectomy surgery not planned
Women younger than 18 or older than 80 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours following surgery
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see how lowering the pressure during surgery for laparoscopic hysterectomy affects pain after surgery, the need for pain medication, and the safety and practicality of the procedure."
Who is the study for?
This trial is for individuals undergoing laparoscopic hysterectomy, a minimally invasive surgery to remove the uterus. Participants must meet certain health criteria set by the researchers but these specific requirements are not provided in the given information.
What is being tested?
The study is testing two different levels of gas pressure used during surgery: standard insufflation pressure versus lower insufflation pressure. The goal is to see which one results in less pain after surgery and how they affect safety and use of painkillers.
What are the potential side effects?
While specific side effects are not listed, potential risks may include discomfort from differing gas pressures during surgery, variations in postoperative pain levels, and possible impacts on surgical safety.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a laparoscopic hysterectomy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not planning to have a laparoscopic hysterectomy.
Select...
I am a woman aged between 18 and 80.
Select...
My BMI is over 55.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours following surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours following surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain on postoperative day 1
Secondary study objectives
Opioid use after discharge
Postoperative pain at follow-up visit
Postoperative pain while in PACU
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 12 mmHg Insufflation PressureExperimental Treatment1 Intervention
Participants received 12 mmHg of insufflation pressure during their laparoscopic hysterectomy.
Group II: 15 mmHg Insufflation PressureActive Control1 Intervention
Participants received 15 mmHg of insufflation pressure during their laparoscopic hysterectomy.
Find a Location
Who is running the clinical trial?
University of TennesseeLead Sponsor
198 Previous Clinical Trials
144,610 Total Patients Enrolled
2 Trials studying Postoperative Pain
81 Patients Enrolled for Postoperative Pain