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Completed

NCT Number: NCT03341533

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

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.

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Key information

Conditions

Pain, Postoperative Agnosia Cryotherapy Effect Hysterectomy Narcotic Use Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ice packs plus usual post-op analgesia

Procedure

A 9 inch by 12 inch zip lock bag filled with ice chips, placed inside a cotton pillow case, placed directly on the abdomen. Ice chips will be replaced as they thaw. Monitoring of surgical sites, skin integrity, and comfort with ice pack in place by nursing per current procedural guidelines.

Usual post-op analgesia

Other

Standard post-operative analgesia orders will be followed.

Primary outcomes

  1. 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.

  2. 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

  1. Mean Morphine Metabolic Equivalents (MME) Consumption: Outpatient

    Time frame: 2 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.

  2. Brief Pain Inventory Short Form - Postoperative Pain Severity

    Time frame: one 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 14, 2017
Registry last updated
May 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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