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Clinical Trials/NCT03341533
NCT03341533
Completed
Not Applicable

Abdominal Ice Packs for Pain Control and Reduction of Narcotic Use Following Laparoscopic Hysterectomy: A Randomized Controlled Trial

Mayo Clinic1 site in 1 country142 target enrollmentJanuary 12, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
Mayo Clinic
Enrollment
142
Locations
1
Primary Endpoint
Numeric Pain Intensity Scale
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 12, 2018
End Date
April 16, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tatnai L. Burnett

Senior Associate Consultant

Mayo Clinic

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

Outcomes

Primary Outcomes

Numeric Pain Intensity Scale

Time Frame: 12 hours post-operatively

Self-reported pain intensity scores (Numerical Pain Intensity Scale, 0-10 visual analog scale with 0 representing no pain and 10 representing the worst pain imaginable) assessed and documented a minimum every four hours post-operatively. Mean differences of pain intensity assessed between ice group and usual care group.

Mean Morphine Metabolic Equivalents (MME) Consumption: Inpatient Floor

Time Frame: an average of one day from entering hospital floor to discharge

Calculation of average patient MME from the time enter hospital floor to hospital discharge. Administered narcotics will be abstracted from the medical record and converted to total MME for analysis.

Secondary Outcomes

  • Mean Morphine Metabolic Equivalents (MME) Consumption: Outpatient(2 weeks)
  • Brief Pain Inventory Short Form - Postoperative Pain Severity(one day after surgery)

Study Sites (1)

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