Clinical trial NCT03341533: Abdominal Ice Packs for Pain Control and Reduction of Narcotic Use Following Laparoscopic Hysterectomy
Official title: Abdominal Ice Packs for Pain Control and Reduction of Narcotic Use Following Laparoscopic Hysterectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Hysterectomy
Narcotic Use
Cryotherapy Effect
Keywords: Analgesia
Laparoscopy
Pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of using ice packs on the abdomen immediately after laparoscopic hysterectomy surgery on pain control and narcotic pain medication use.

Detailed description: Hysterectomy is one of the most common surgical procedures performed on women in the United States, with approximately 600,000 performed annually. The use of postoperative cooling as an adjuvant for post-operative pain control has previously been shown to be effective and safe in a variety of procedures, but has yet to be described for laparoscopic surgery. In contrast to laparotomy where the wound is a significant pain generator and direct application of ice is intuitive, in laparoscopic surgery much of the pain-generating tissue trauma is intraperitoneal and pelvic in nature, away from the abdominal wall. Ice pack use on the abdominal wall likely inhibits visceral afferent pain fibers via somatic afferent nerve cross-talk. Accordingly, applying ice to the abdominal wall and its somatic afferents may improve laparoscopic pain control, despite the lack of a significant abdominal wound. Our goal is to quantify narcotic use after hospital discharge following hysterectomy, and evaluate the effectiveness of abdominal ice packs as low cost adjuncts for pain control.

Eligibility criteria: Inclusion Criteria:

* Women undergoing robotic or conventional laparoscopic hysterectomy

Exclusion Criteria:

* Any opioid use within 2 weeks of surgery date
* Planned post-operative ICU admission
* Conversion of laparoscopic approach to laparotomy or any incision ≥4 cm
* Regional anesthesia/analgesia, including tap block use

Primary outcomes:
measure: Numeric Pain Intensity Scale
timeFrame: 12 hours post-operatively
measure: Mean Morphine Metabolic Equivalents (MME) Consumption: Inpatient Floor
timeFrame: an average of one day from entering hospital floor to discharge
Secondary outcomes:
measure: Mean Morphine Metabolic Equivalents (MME) Consumption: Outpatient
timeFrame: 2 weeks
measure: Brief Pain Inventory Short Form - Postoperative Pain Severity
timeFrame: one day after surgery
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Obstetrics and Gynecology
name: Tatnai L. Burnett, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cope AG, Wetzstein MM, Mara KC, Laughlin-Tommaso SK, Warner NS, Burnett TL. Abdominal Ice after Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 Feb;28(2):342-350.e2. doi: 10.1016/j.jmig.2020.06.027. Epub 2020 Jul 3.