Cryotherapy Effect, Hysterectomy, Narcotic Use, Pain, Postoperative
Conditions
Keywords
Analgesia, Laparoscopy, Pain
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.
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.
Interventions
PROCEDUREIce 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.
OTHERUsual post-op analgesia
Standard post-operative analgesia orders will be followed.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 69 |
| Usual Post-op Analgesia Standard post-operative analgesia only, no ice use.
Usual post-op analgesia: Standard post-operative analgesia orders will be followed. | 68 |
| Total | 137 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Not eligible after randomization | 2 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Ice Packs Plus Usual Post-op Analgesia | Usual Post-op Analgesia | Total |
|---|---|---|---|
| Age, Continuous | 57.3 years STANDARD_DEVIATION 11.1 | 56.9 years STANDARD_DEVIATION 13 | 57.1 years STANDARD_DEVIATION 12 |
| Race/Ethnicity, Customized Caucasian | 68 Participants | 66 Participants | 134 Participants |
| Race/Ethnicity, Customized Choose Not to Disclose | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 69 participants | 68 participants | 137 participants |
| Sex: Female, Male Female | 69 Participants | 68 Participants | 137 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 70 |
| other Total, other adverse events | 5 / 72 | 5 / 70 |
| serious Total, serious adverse events | 3 / 72 | 4 / 70 |
Outcome results
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.
Time frame: an average of one day from entering hospital floor to discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ice Packs Plus Usual Post-op Analgesia | Mean Morphine Metabolic Equivalents (MME) Consumption: Inpatient Floor | 7.5 MME |
| Usual Post-op Analgesia | Mean Morphine Metabolic Equivalents (MME) Consumption: Inpatient Floor | 12 MME |
p-value: 0.88Kruskal-Wallis
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.
Time frame: 12 hours post-operatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ice Packs Plus Usual Post-op Analgesia | Numeric Pain Intensity Scale | 3 score on a scale |
| Usual Post-op Analgesia | Numeric Pain Intensity Scale | 3 score on a scale |
p-value: 0.39Kruskal-Wallis
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.
Time frame: one day after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ice Packs Plus Usual Post-op Analgesia | Brief Pain Inventory Short Form - Postoperative Pain Severity | 3 score on a scale |
| Usual Post-op Analgesia | Brief Pain Inventory Short Form - Postoperative Pain Severity | 3.3 score on a scale |
p-value: 0.8Kruskal-Wallis
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ice Packs Plus Usual Post-op Analgesia | Mean Morphine Metabolic Equivalents (MME) Consumption: Outpatient | 29.5 MME |
| Usual Post-op Analgesia | Mean Morphine Metabolic Equivalents (MME) Consumption: Outpatient | 26.5 MME |
p-value: 0.75Kruskal-Wallis