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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-12

Study Completion Date

2020-04-16

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pain, Postoperative Hysterectomy Narcotic Use Cryotherapy Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ice packs plus usual post-op analgesia

Ice 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.

Group Type EXPERIMENTAL

Ice packs plus usual post-op analgesia

Intervention Type 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

Intervention Type OTHER

Standard post-operative analgesia orders will be followed.

Usual post-op analgesia

Standard post-operative analgesia only, no ice use.

Group Type ACTIVE_COMPARATOR

Usual post-op analgesia

Intervention Type OTHER

Standard post-operative analgesia orders will be followed.

Interventions

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Ice packs plus usual post-op analgesia

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.

Intervention Type PROCEDURE

Usual post-op analgesia

Standard post-operative analgesia orders will be followed.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No