NCT06508814

Pain With Differing Insufflation Pressures During Laparoscopic Hysterectomy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Tennessee · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Post Operative Pain

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	Standard Insufflation Pressure	Participants underwent laparoscopic hysterectomy with a standard insufflation pressure.

Timeline

• Start date: 2024-06-10
• Primary completion: 2025-06-10
• Completion: 2025-06-10
• First posted: 2024-07-18
• Last updated: 2024-07-23

Locations

1 site across 1 country: United States