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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT03341533
• Collaborator: (none)
• Enrollment: 142
• Location: 1
• Arms: 2
• Actual Duration (Months): 27.1
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative; Hysterectomy; Narcotic Use; Cryotherapy Effect	Procedure: Ice packs plus usual post-op analgesia; Other: Usual post-op analgesia	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 142 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Abdominal Ice Packs for Pain Control and Reduction of Narcotic Use Following Laparoscopic Hysterectomy: A Randomized Controlled Trial
• Actual Study Start Date: Jan 12, 2018
• Actual Primary Completion Date: Apr 5, 2019
• Actual Study Completion Date: Apr 16, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Active Comparator: Usual post-op analgesia Standard post-operative analgesia only, no ice use.	Other: Usual post-op analgesia; Standard post-operative analgesia orders will be followed.

Outcome Measures

Primary Outcome Measures

1. Numeric Pain Intensity Scale [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 [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 Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Tatnai L. Burnett, M.D., Obstetrics and Gynecology

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Oct 25, 2018

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Tatnai L. Burnett, Senior Associate Consultant, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03341533
• Other Study ID Numbers: 17-007182
• First Posted: Nov 14, 2017
• Last Update Posted: May 14, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tatnai L. Burnett, Senior Associate Consultant, Mayo Clinic: Analgesia; Laparoscopy; Pain
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

Participant Flow

Arm/Group Title	Ice Packs Plus Usual Post-op Analgesia	Usual Post-op Analgesia
Arm/Group Description	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. 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. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.	Standard post-operative analgesia only, no ice use. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.
Period Title: Overall Study
STARTED	72	70
COMPLETED	69	68
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Ice Packs Plus Usual Post-op Analgesia	Usual Post-op Analgesia	Total
Arm/Group Description	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. 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. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.	Standard post-operative analgesia only, no ice use. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.	Total of all reporting groups
Overall Participants	69	68	137
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.3 (11.1)	56.9 (13)	57.1 (12)
Sex: Female, Male (Count of Participants)
Female	69 100%	68 100%	137 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	68 98.6%	66 97.1%	134 97.8%
Other	1 1.4%	0 0%	1 0.7%
Choose Not to Disclose	0 0%	1 1.5%	1 0.7%
Unknown	0 0%	1 1.5%	1 0.7%
Region of Enrollment (participants) [Number]
United States	69 100%	68 100%	137 100%

Outcome Measures

1. Primary Outcome

Title	Numeric Pain Intensity Scale
Description	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.
Time Frame	12 hours post-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ice Packs Plus Usual Post-op Analgesia	Usual Post-op Analgesia
Arm/Group Description	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. 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. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.	Standard post-operative analgesia only, no ice use. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.
Measure Participants	69	68
Median (Inter-Quartile Range) [score on a scale]	3	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ice Packs Plus Usual Post-op Analgesia, Usual Post-op Analgesia
	Comments
	Type of Statistical Test	Equivalence
	Comments	The null hypothesis is that there is no difference in NPIS between the two groups.
Statistical Test of Hypothesis	p-Value	0.39
	Comments
	Method	Kruskal-Wallis
	Comments
Method of Estimation	Estimation Parameter	difference in medians
	Estimated Value	0.0
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Mean Morphine Metabolic Equivalents (MME) Consumption: Inpatient Floor
Description	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.
Time Frame	an average of one day from entering hospital floor to discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ice Packs Plus Usual Post-op Analgesia	Usual Post-op Analgesia
Arm/Group Description	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. 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. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.	Standard post-operative analgesia only, no ice use. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.
Measure Participants	69	68
Median (Full Range) [MME]	7.5	12

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ice Packs Plus Usual Post-op Analgesia, Usual Post-op Analgesia
	Comments
	Type of Statistical Test	Equivalence
	Comments	The null hypothesis is that there is no difference in MME use on the hospital floor between groups.
Statistical Test of Hypothesis	p-Value	0.88
	Comments
	Method	Kruskal-Wallis
	Comments
Method of Estimation	Estimation Parameter	Difference of medians
	Estimated Value	-4.5
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Ice packs - Usual care

3. Secondary Outcome

Title	Mean Morphine Metabolic Equivalents (MME) Consumption: Outpatient
Description	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.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Some patients (N=6 ice pack patients and N=6 usual care patients) kept a diary of at home narcotic use after discharge as directed, which is why the numbers for this analysis are lower than the total number of patients.

Arm/Group Title	Ice Packs Plus Usual Post-op Analgesia	Usual Post-op Analgesia
Arm/Group Description	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. 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. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.	Standard post-operative analgesia only, no ice use. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.
Measure Participants	63	62
Median (Full Range) [MME]	29.5	26.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ice Packs Plus Usual Post-op Analgesia, Usual Post-op Analgesia
	Comments
	Type of Statistical Test	Equivalence
	Comments	The null hypothesis is that the outpatient MME consumption will be the same across the two groups.
Statistical Test of Hypothesis	p-Value	0.75
	Comments
	Method	Kruskal-Wallis
	Comments
Method of Estimation	Estimation Parameter	difference in medians
	Estimated Value	-7.5
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Ice packs - Usual Care

4. Secondary Outcome

Title	Brief Pain Inventory Short Form - Postoperative Pain Severity
Description	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.
Time Frame	one day after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ice Packs Plus Usual Post-op Analgesia	Usual Post-op Analgesia
Arm/Group Description	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. 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. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.	Standard post-operative analgesia only, no ice use. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.
Measure Participants	67	68
Median (Inter-Quartile Range) [score on a scale]	3	3.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ice Packs Plus Usual Post-op Analgesia, Usual Post-op Analgesia
	Comments
	Type of Statistical Test	Equivalence
	Comments	The null hypothesis is that the postoperative BPI pain severity score will be the same between groups
Statistical Test of Hypothesis	p-Value	0.80
	Comments
	Method	Kruskal-Wallis
	Comments
Method of Estimation	Estimation Parameter	difference in medians
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Ice Packs - Usual Care

Adverse Events

Time Frame	Adverse event data were collected from immediately after the operation until the scheduled 6 - 8 week postoperative visit. Systematic assessment for occurrence of adverse events was performed by study personnel at all points of contact during the postoperative course and by record review.
Arm/Group Title	Ice Packs Plus Usual Post-op Analgesia		Usual Post-op Analgesia
Arm/Group Description	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. 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. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.		Standard post-operative analgesia only, no ice use. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.
All Cause Mortality
	Ice Packs Plus Usual Post-op Analgesia		Usual Post-op Analgesia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/72 (0%)		0/70 (0%)
Serious Adverse Events
	Ice Packs Plus Usual Post-op Analgesia		Usual Post-op Analgesia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/72 (4.2%)		4/70 (5.7%)
Respiratory, thoracic and mediastinal disorders
Postoperative Pulmonary Edema	0/72 (0%)	0	1/70 (1.4%)	1
Surgical and medical procedures
Vaginal cuff dehiscence	1/72 (1.4%)	1	1/70 (1.4%)	1
Vaginal cuff bleeding	0/72 (0%)	0	2/70 (2.9%)	2
Bowel injury and subsequent sepsis	1/72 (1.4%)	1	0/70 (0%)	0
Wound infection	1/72 (1.4%)	1	0/70 (0%)	0
Other (Not Including Serious) Adverse Events
	Ice Packs Plus Usual Post-op Analgesia		Usual Post-op Analgesia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/72 (6.9%)		5/70 (7.1%)
Gastrointestinal disorders
Nause	0/72 (0%)	0	1/70 (1.4%)	1
Immune system disorders
Allergic reaction to medication	1/72 (1.4%)	1	0/70 (0%)	0
Renal and urinary disorders
Urinary Tract Infection	1/72 (1.4%)	1	1/70 (1.4%)	1
Urinary Incontinence	1/72 (1.4%)	1	1/70 (1.4%)	1
Urinary retention	1/72 (1.4%)	1	0/70 (0%)	0
Reproductive system and breast disorders
New onset pelvic pain	0/72 (0%)	0	1/70 (1.4%)	1
Skin and subcutaneous tissue disorders
Skin erythema	0/72 (0%)	0	1/70 (1.4%)	1
Surgical and medical procedures
Postoperative fever and pain	1/72 (1.4%)	1	0/70 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.