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This is a pilot randomized controlled trial examining post-operative pain scores and outcomes after laparoscopic hysterectomy in patients prescribed cold therapy as an adjunct to routine post-operative multi-modal analgesia, compared to those patients prescribed routine multi-modal analgesia without cold therapy. All patients scheduled for total laparoscopic hysterectomy (without robotic-assistance) will be screened for eligibility in the study. If eligible, patients will be invited to participate in the study and standardized informed consent process will ensue. After surgery is completed participants will be randomized to either the control group or the study group. The study group will be prescribed the use of cold therapy to their abdominal incisions through reusable cold gel packs. The cold therapy is to be applied to participants' incisions for the first three postoperative days, in addition to routine post-operative analgesia regimen. Investigators will then collect information on pain scores, narcotic use, quality of life and surgical recovery scores.
This study aims to examine if there is a difference in post-operative pain scores with the application of cold therapy to laparoscopic abdominal incisions following laparoscopic hysterectomy, when compared to no cold therapy. Secondarily, investigators will examine post-operative quality of life scores, postoperative surgical recovery scores, as well as narcotic use among the two groups. Investigators also aim to ascertain additional information regarding total quantity of narcotics used post-operatively to aid in prescribing patterns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold Therapy | Experimental | Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. Intervention will include the patient being asked to use a reusable cold gel pack to deliver cold therapy to their abdominal incisions every 6 hours for the first 72 hours. |
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| Control | No Intervention | Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. They will not receive any additional intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold therapy via reusable cold gel pack | Device | Patients in the experimental group will be asked to apply cold therapy to their abdominal incisions every 6 hours for the first 72 hours following their surgery (total laparoscopic hysterectomy). Cold therapy will be applied via a reusable cold gel pack. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain Score | Post-operative pain score on an 11 point numeric rating scale, minimum value of 0 and maximum value of 10, zero meaning no pain and 10 meaning the worst pain imaginable. | 24 hours post-operatively following total laparoscopic hysterectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain Score | Post-operative pain score on an 11 point numeric rating scale, minimum value of 0 and maximum value of 10, zero meaning no pain and 10 meaning the worst pain imaginable. | 72 hours post-operatively following total laparoscopic hysterectomy |
| Patient Reported Quantity of Narcotics Used Post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Total Amount of Narcotics Used Post-operatively | Total amount of narcotics used post-operatively within the first two weeks after surgery measured in MME, intravenous morphine milligram equivalents. | 10-14 days postoperatively following total laparoscopic hysterectomy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael L Sprague, MD | Cleveland Clinic Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cold Therapy | Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. Intervention will include the patient being asked to use a reusable cold gel pack to deliver cold therapy to their abdominal incisions every 6 hours for the first 72 hours. Cold therapy via reusable cold gel pack: Patients in the experimental group will be asked to apply cold therapy to their abdominal incisions every 6 hours for the first 72 hours following their surgery (total laparoscopic hysterectomy). Cold therapy will be applied via a reusable cold gel pack. |
| FG001 | Control | Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. They will not receive any additional intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cold Therapy | Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. Intervention will include the patient being asked to use a reusable cold gel pack to deliver cold therapy to their abdominal incisions every 6 hours for the first 72 hours. Cold therapy via reusable cold gel pack: Patients in the experimental group will be asked to apply cold therapy to their abdominal incisions every 6 hours for the first 72 hours following their surgery (total laparoscopic hysterectomy). Cold therapy will be applied via a reusable cold gel pack. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Post-operative Pain Score | Post-operative pain score on an 11 point numeric rating scale, minimum value of 0 and maximum value of 10, zero meaning no pain and 10 meaning the worst pain imaginable. | Posted | Median | Inter-Quartile Range | units on a scale | 24 hours post-operatively following total laparoscopic hysterectomy |
|
90 days
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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 | Cold Therapy | Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. Intervention will include the patient being asked to use a reusable cold gel pack to deliver cold therapy to their abdominal incisions every 6 hours for the first 72 hours. Cold therapy via reusable cold gel pack: Patients in the experimental group will be asked to apply cold therapy to their abdominal incisions every 6 hours for the first 72 hours following their surgery (total laparoscopic hysterectomy). Cold therapy will be applied via a reusable cold gel pack. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Frazzini Padilla | Cleveland Clinic Florida | 9546595559f | frazzip@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 27, 2016 | Nov 30, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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|
Patient reported quantity of narcotics used post-operatively measured in number of reported 5 mg oxycodone tabs consumed |
| 72 hours post-operatively following total laparoscopic hysterectomy |
| Quality of Life Score as Measured by the Validated Abdominal Surgery Impact Scale | Quality of life score as measured by the validated Abdominal Surgery Impact Scale, minimum value is 18, maximum value is 126, with lower values indicating a worse quality of life and higher scores indicating a better quality of life. | 72 hours post-operatively following total laparoscopic hysterectomy |
| Surgical Recovery Score as Measured by the Validated Surgical Recovery Scale | Functional surgical recovery following major surgery as measured by the validated Surgical Recovery Scale, possible scores range from 0 to 60, with higher scores indicating a better recovery | 10-14 days post-operatively following total laparoscopic hysterectomy |
| BG001 | Control | Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. They will not receive any additional intervention. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Control | Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. They will not receive any additional intervention. |
|
|
| Secondary | Post-operative Pain Score | Post-operative pain score on an 11 point numeric rating scale, minimum value of 0 and maximum value of 10, zero meaning no pain and 10 meaning the worst pain imaginable. | Posted | Median | Inter-Quartile Range | score on a scale | 72 hours post-operatively following total laparoscopic hysterectomy |
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|
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| Secondary | Patient Reported Quantity of Narcotics Used Post-operatively | Patient reported quantity of narcotics used post-operatively measured in number of reported 5 mg oxycodone tabs consumed | Posted | Mean | Standard Deviation | oxycodone tabs | 72 hours post-operatively following total laparoscopic hysterectomy |
|
|
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| Secondary | Quality of Life Score as Measured by the Validated Abdominal Surgery Impact Scale | Quality of life score as measured by the validated Abdominal Surgery Impact Scale, minimum value is 18, maximum value is 126, with lower values indicating a worse quality of life and higher scores indicating a better quality of life. | Posted | Mean | Standard Deviation | score on a scale | 72 hours post-operatively following total laparoscopic hysterectomy |
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|
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| Secondary | Surgical Recovery Score as Measured by the Validated Surgical Recovery Scale | Functional surgical recovery following major surgery as measured by the validated Surgical Recovery Scale, possible scores range from 0 to 60, with higher scores indicating a better recovery | Posted | Mean | Standard Deviation | score on a scale | 10-14 days post-operatively following total laparoscopic hysterectomy |
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| Other Pre-specified | Total Amount of Narcotics Used Post-operatively | Total amount of narcotics used post-operatively within the first two weeks after surgery measured in MME, intravenous morphine milligram equivalents. | Posted | Mean | Standard Deviation | MME, intravenous morphine milligram equi | 10-14 days postoperatively following total laparoscopic hysterectomy |
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| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Control | Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. They will not receive any additional intervention. | 0 | 28 | 0 | 28 | 0 | 28 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |