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Abdominal Ice Packs for Pain Control and Reduction of Narcotic Use Following Laparoscopic Hysterectomy

Not Applicable
Completed
Conditions
Cryotherapy Effect
Pain, Postoperative
Hysterectomy
Narcotic Use
Interventions
Procedure: Ice packs plus usual post-op analgesia
Other: Usual post-op analgesia
Registration Number
NCT03341533
Lead Sponsor
Mayo Clinic
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
142
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Ice packs plus usual post-op analgesiaIce packs plus usual post-op analgesiaIce pack applied to the abdomen and maintained continuously for the first 12 hours post-operatively. Standard standard post-operative analgesia orders will be followed in addition to use of ice.
Ice packs plus usual post-op analgesiaUsual post-op analgesiaIce pack applied to the abdomen and maintained continuously for the first 12 hours post-operatively. Standard standard post-operative analgesia orders will be followed in addition to use of ice.
Usual post-op analgesiaUsual post-op analgesiaStandard post-operative analgesia only, no ice use.
Primary Outcome Measures
NameTimeMethod
Numeric Pain Intensity Scale12 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 Flooran 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 Outcome Measures
NameTimeMethod
Mean Morphine Metabolic Equivalents (MME) Consumption: Outpatient2 weeks

Calculation of average patient MME from the time of hospital discharge to end of narcotic use for post-operative pain control. Patients will keep detailed home diary of narcotic analgesia use after discharge. Total narcotic intake recorded on the diary will be converted to MME for analysis.

Brief Pain Inventory Short Form - Postoperative Pain Severityone day after surgery

Brief Pain Inventory Short Form scores (Pain diagram to indicate location of pain and 7 Likert-scale questions assessing pain severity and interference with feeling and function, scores ranging from 0 = No pain to 10 = pain as bad as you can imagine) assessed pre-op and again post-operatively, just before hospital discharge (at last 12 but no more than 24 hours after surgery). Mean differences calculated between ice group and usual care group.

Trial Locations

Locations (1)

Mayo Clinic in Rochester

🇺🇸

Rochester, Minnesota, United States

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