Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508814
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Pain With Differing Insufflation Pressures During Laparoscopic Hysterectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pain With Differing Insufflation Pressures During Laparoscopic Hysterectomy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None