Trial Outcomes & Findings for Abdominal Ice Packs for Pain Control and Reduction of Narcotic Use Following Laparoscopic Hysterectomy (NCT NCT03341533)

NCT ID: NCT03341533

Last Updated: 2020-05-14

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 142 participants
• Primary outcome timeframe: 12 hours post-operatively
• Results posted on: 2020-05-14

Participant Flow

Participant milestones

Measure	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. 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.	Usual Post-op Analgesia Standard post-operative analgesia only, no ice use. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.
Overall Study STARTED	72	70
Overall Study COMPLETED	69	68
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	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. 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.	Usual Post-op Analgesia Standard post-operative analgesia only, no ice use. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.
Overall Study Withdrawal by Subject	1	1
Overall Study Not eligible after randomization	2	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Ice Packs Plus Usual Post-op Analgesia n=69 Participants 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.	Usual Post-op Analgesia n=68 Participants Standard post-operative analgesia only, no ice use. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.	Total n=137 Participants Total of all reporting groups
Age, Continuous	57.3 years STANDARD_DEVIATION 11.1 • n=5 Participants	56.9 years STANDARD_DEVIATION 13 • n=7 Participants	57.1 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	68 Participants n=7 Participants	137 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	68 Participants n=5 Participants	66 Participants n=7 Participants	134 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Choose Not to Disclose	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants	68 participants n=7 Participants	137 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Ice Packs Plus Usual Post-op Analgesia n=69 Participants 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.	Usual Post-op Analgesia n=68 Participants Standard post-operative analgesia only, no ice use. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.
Numeric Pain Intensity Scale	3 score on a scale Interval 1.0 to 4.0	3 score on a scale Interval 2.0 to 4.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Ice Packs Plus Usual Post-op Analgesia n=69 Participants 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.	Usual Post-op Analgesia n=68 Participants Standard post-operative analgesia only, no ice use. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.
Mean Morphine Metabolic Equivalents (MME) Consumption: Inpatient Floor	7.5 MME Interval 0.0 to 67.5	12 MME Interval 0.0 to 67.5

SECONDARY outcome

Timeframe: 2 weeks

Population: 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.

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.

Outcome measures

Measure	Ice Packs Plus Usual Post-op Analgesia n=63 Participants 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.	Usual Post-op Analgesia n=62 Participants Standard post-operative analgesia only, no ice use. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.
Mean Morphine Metabolic Equivalents (MME) Consumption: Outpatient	29.5 MME Interval 0.0 to 224.9	26.5 MME Interval 0.0 to 175.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ice Packs Plus Usual Post-op Analgesia n=67 Participants 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.	Usual Post-op Analgesia n=68 Participants Standard post-operative analgesia only, no ice use. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.
Brief Pain Inventory Short Form - Postoperative Pain Severity	3 score on a scale Interval 2.0 to 4.0	3.3 score on a scale Interval 2.1 to 4.3

Adverse Events

Ice Packs Plus Usual Post-op Analgesia

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Usual Post-op Analgesia

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ice Packs Plus Usual Post-op Analgesia n=72 participants at risk 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.	Usual Post-op Analgesia n=70 participants at risk Standard post-operative analgesia only, no ice use. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.
Surgical and medical procedures Vaginal cuff dehiscence	1.4% 1/72 • Number of events 1 • 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.	1.4% 1/70 • Number of events 1 • 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.
Surgical and medical procedures Vaginal cuff bleeding	0.00% 0/72 • 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.	2.9% 2/70 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Postoperative Pulmonary Edema	0.00% 0/72 • 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.	1.4% 1/70 • Number of events 1 • 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.
Surgical and medical procedures Bowel injury and subsequent sepsis	1.4% 1/72 • Number of events 1 • 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.	0.00% 0/70 • 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.
Surgical and medical procedures Wound infection	1.4% 1/72 • Number of events 1 • 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.	0.00% 0/70 • 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.

Other adverse events

Measure	Ice Packs Plus Usual Post-op Analgesia n=72 participants at risk 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.	Usual Post-op Analgesia n=70 participants at risk Standard post-operative analgesia only, no ice use. Usual post-op analgesia: Standard post-operative analgesia orders will be followed.
Renal and urinary disorders Urinary Tract Infection	1.4% 1/72 • Number of events 1 • 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.	1.4% 1/70 • Number of events 1 • 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.
Renal and urinary disorders Urinary Incontinence	1.4% 1/72 • Number of events 1 • 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.	1.4% 1/70 • Number of events 1 • 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.
Gastrointestinal disorders Nause	0.00% 0/72 • 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.	1.4% 1/70 • Number of events 1 • 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.
Reproductive system and breast disorders New onset pelvic pain	0.00% 0/72 • 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.	1.4% 1/70 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Skin erythema	0.00% 0/72 • 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.	1.4% 1/70 • Number of events 1 • 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.
Renal and urinary disorders Urinary retention	1.4% 1/72 • Number of events 1 • 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.	0.00% 0/70 • 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.
Surgical and medical procedures Postoperative fever and pain	1.4% 1/72 • Number of events 1 • 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.	0.00% 0/70 • 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.
Immune system disorders Allergic reaction to medication	1.4% 1/72 • Number of events 1 • 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.	0.00% 0/70 • 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.

Additional Information

Dr. Tatnai Burnett

Mayo Clinic

Phone: 507-538-5783

Email: burnett.tatnai@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place