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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03341533
• Other study ID #: 17-007182
• Status: Completed
• Phase: N/A
• Start date: January 12, 2018
• Est. completion date: April 16, 2020

Study information

• Verified date: May 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: April 16, 2020
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cryotherapy Effect
• Hysterectomy
• Narcotic Use
• Pain, Postoperative

Intervention

Procedure:
• 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.

Other:
• Usual post-op analgesia
Standard post-operative analgesia orders will be followed.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Intensity Scale	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.	12 hours post-operatively
Primary	Mean Morphine Metabolic Equivalents (MME) Consumption: Inpatient Floor	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.	an average of one day from entering hospital floor to discharge
Secondary	Mean Morphine Metabolic Equivalents (MME) Consumption: Outpatient	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 weeks
Secondary	Brief Pain Inventory Short Form - Postoperative Pain Severity	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.	one day after surgery

External Links

•   Mayo Clinic Clinical Trials