Effect of Insufflation Pressure on Pain After Laparoscopic Hysterectomy
Pain With Differing Insufflation Pressures During Laparoscopic Hysterectomy
This study tests if using lower air pressure during laparoscopic hysterectomy can reduce pain and the need for pain relief after surgery for women undergoing the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | University of Tennessee Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT06508814 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how different levels of insufflation pressure during laparoscopic hysterectomy affect postoperative pain, the need for analgesics, and overall surgical safety. Participants will be randomly assigned to receive either standard insufflation pressure of 15 mmHg or a reduced pressure of 12 mmHg. Pain levels will be assessed using a Visual Analog Scale (VAS) on the first postoperative day and again two weeks after surgery. Additional data on operative time, blood loss, and recovery will also be collected to evaluate the feasibility of the procedure under different pressures.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 80 with a BMI of 55.0 or less who are scheduled for laparoscopic hysterectomy.
Not a fit: Patients who are younger than 18, older than 80, or have a BMI over 55.0 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced postoperative pain and lower analgesic use for patients undergoing laparoscopic hysterectomy.
How similar studies have performed: Other studies have explored the impact of insufflation pressures in laparoscopic procedures, suggesting potential benefits, but this specific approach is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Memphis, Tennessee
- University of Tennessee Health Science Center — Memphis, Tennessee, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.