Pain With Differing Insufflation Pressures During Laparoscopic Hysterectomy

University of Tennessee

Status: Enrolling

Conditions: Post Operative Pain

Treatments: Procedure: Standard Insufflation Pressure; Procedure: Lower Insufflation Pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT06508814

24-09977-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

12 mmHg Insufflation Pressure

Experimental group

Description:

Participants received 12 mmHg of insufflation pressure during their laparoscopic hysterectomy.

Treatment:

Procedure: Lower Insufflation Pressure

15 mmHg Insufflation Pressure

Active Comparator group

Description:

Participants received 15 mmHg of insufflation pressure during their laparoscopic hysterectomy.

Treatment:

Procedure: Standard Insufflation Pressure