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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ice packs plus usual post-op analgesia | Experimental | 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. |
|
| Usual post-op analgesia | Active Comparator | Standard post-operative analgesia only, no ice use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tatnai L. Burnett, M.D. | Obstetrics and Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32622918 | Derived | Cope AG, Wetzstein MM, Mara KC, Laughlin-Tommaso SK, Warner NS, Burnett TL. Abdominal Ice after Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 Feb;28(2):342-350.e2. doi: 10.1016/j.jmig.2020.06.027. Epub 2020 Jul 3. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Post-op Analgesia | Standard post-operative analgesia only, no ice use. Usual post-op analgesia: Standard post-operative analgesia orders will be followed. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | 12 hours post-operatively |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal cuff dehiscence | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tatnai Burnett | Mayo Clinic | 507-538-5783 | burnett.tatnai@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 25, 2018 | Apr 21, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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|
| Usual post-op analgesia | Other | Standard post-operative analgesia orders will be followed. |
|
| 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 |
| BG001 | Usual Post-op Analgesia | Standard post-operative analgesia only, no ice use. Usual post-op analgesia: Standard post-operative analgesia orders will be followed. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Usual Post-op Analgesia | Standard post-operative analgesia only, no ice use. Usual post-op analgesia: Standard post-operative analgesia orders will be followed. |
|
|
|
| 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. | Posted | Median | Full Range | MME | 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. | 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. | Posted | Median | Full Range | MME | 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. | Posted | Median | Inter-Quartile Range | score on a scale | one day after surgery |
|
|
|
|
| 0 |
| 72 |
| 3 |
| 72 |
| 5 |
| 72 |
| EG001 | Usual Post-op Analgesia | Standard post-operative analgesia only, no ice use. Usual post-op analgesia: Standard post-operative analgesia orders will be followed. | 0 | 70 | 4 | 70 | 5 | 70 |
| Vaginal cuff bleeding | Surgical and medical procedures | Systematic Assessment |
|
| Postoperative Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bowel injury and subsequent sepsis | Surgical and medical procedures | Systematic Assessment |
|
| Wound infection | Surgical and medical procedures | Systematic Assessment |
|
| Urinary Incontinence | Renal and urinary disorders | Systematic Assessment |
|
| Nause | Gastrointestinal disorders | Systematic Assessment |
|
| New onset pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
|
| Skin erythema | Skin and subcutaneous tissue disorders | Systematic Assessment | Related to ice |
|
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
| Postoperative fever and pain | Surgical and medical procedures | Systematic Assessment |
|
| Allergic reaction to medication | Immune system disorders | Systematic Assessment |
|
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| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |