Clinical trial NCT06508814: Pain With Differing Insufflation Pressures During Laparoscopic Hysterectomy
Official title: Pain With Differing Insufflation Pressures During Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Pain on postoperative day 1
timeFrame: 24 hours following surgery
Secondary outcomes:
measure: Preoperative pain
timeFrame: Within 2 hours before surgery
measure: Postoperative pain while in PACU
timeFrame: Approximately 2 hours after surgery completion
measure: Postoperative pain at follow-up visit
timeFrame: Approximately 2 weeks after surgery completion
measure: Opioid use after discharge
timeFrame: Within 2 weeks after surgery
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
Study officials:
References:
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citation: Kyle EB, Maheux-Lacroix S, Boutin A, Laberge PY, Lemyre M. Low vs Standard Pressures in Gynecologic Laparoscopy: a Systematic Review. JSLS. 2016 Jan-Mar;20(1):e2015.00113. doi: 10.4293/JSLS.2015.00113.
citation: Grant A, Keltz J, Huang K. Is Decreased Insufflation Pressure During Major Robotic-Assisted Gynecologic Surgery Associated With Decreased Recovery Time and Patient Reported Pain Score. J Minim Invasive Gynecol. 2015 Nov-Dec;22(6S):S26. doi: 10.1016/j.jmig.2015.08.075. Epub 2015 Oct 15. No abstract available.
citation: Topcu HO, Cavkaytar S, Kokanali K, Guzel AI, Islimye M, Doganay M. A prospective randomized trial of postoperative pain following different insufflation pressures during gynecologic laparoscopy. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:81-5. doi: 10.1016/j.ejogrb.2014.09.003. Epub 2014 Sep 16.
citation: Angioli R, Terranova C, Plotti F, Cafa EV, Gennari P, Ricciardi R, Aloisi A, Miranda A, Montera R, De Cicco Nardone C. Influence of pneumoperitoneum pressure on surgical field during robotic and laparoscopic surgery: a comparative study. Arch Gynecol Obstet. 2015 Apr;291(4):865-8. doi: 10.1007/s00404-014-3494-z. Epub 2014 Sep 27.