Pain With Differing Insufflation Pressures During Laparoscopic Hysterectomy
Purpose
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.
Condition
- Post Operative Pain
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 12 mmHg Insufflation Pressure |
Participants received 12 mmHg of insufflation pressure during their laparoscopic hysterectomy. |
|
|
Active Comparator 15 mmHg Insufflation Pressure |
Participants received 15 mmHg of insufflation pressure during their laparoscopic hysterectomy. |
|
Recruiting Locations
Memphis, Tennessee 38103
More Details
- Status
- Recruiting
- Sponsor
- University of Tennessee
Study Contact
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.