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The purpose of this randomized controlled trial is to determine whether, "ICE-T," a novel multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and tylenol, has improved pain control intake compared to the standard postoperative pain regimen in patients undergoing vaginal pelvic floor reconstructive surgery.
Pelvic floor disorders involve a myriad of complicated, interwoven clinical conditions that involve pelvic organ prolapse, urinary incontinence, fecal incontinence, and other pathology involving the genital and lower urinary tract. It is estimated that pelvic floor disorders affect up to 25% of all adult women in the United States with increasing prevalence with age. By the age of sixty, 1 in 9 women will undergo surgical intervention for pelvic organ prolapse and/or incontinence, increasing to 1 in 5 by the age of 80. As the population in the United States ages, the demand for healthcare for pelvic floor disorders is estimated to increase up to 40% in the next 30 years.
Despite the prevalence of surgery performed for pelvic floor disorders, there is a paucity of data on postoperative pain control that is dedicated to female pelvic reconstructive surgery. In a recent review, there was only one study that evaluated postoperative pain control after vaginal reconstructive surgery, and the mainstay of therapy was opioid driven. Generally, postoperative pain control in gynecologic surgery has been opioid driven, frequently involving multiple narcotics for analgesia, resulting opioid related complications, including nausea, vomiting, constipation, urinary retention, and central nervous system side effects In an effort to combat opioid use in gynecologic and female pelvic reconstructive surgery, multimodal therapy has been gaining momentum with goals of improved pain control and decreased opioid requirements. Ice packs, toradol, and acetaminophen have been used in various trials to decrease postoperative opioid requirements in various surgeries.
Ice packs have been shown to be effective in the treatment of postoperative pain after abdominal midline incisions. A Cochrane Review of patients subject to post vaginal delivery perineal cooling included 10 randomized controlled trials with1825 patients with some evidence that local cooling in the form of ice packs, cold gel packs, cold/ice backs may be effective in pain relief.
Toradol has been extensively studied in a multitude of surgeries including spinal, obstetric, orthopedic, urologic, and gynecologic. It has been administered preemptively, intraoperatively, and postoperatively for pain control with evidence that toradol decreases postoperative subjective pain scores and decreased narcotic use.
Acetaminophen is mainstay for postoperative pain control as part of multimodal pain regimens to complement other, opioid sparing medications in a multitude of surgeries including abdominal hysterectomy.
Therefore, the purpose of this randomized controlled study is to determine whether, "ICE-T" a novel multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and tylenol, has improved pain control and decrease opioid intake compared to the standard postoperative pain regimen in patients undergoing vaginal pelvic floor reconstructive surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICE T | Experimental |
|
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| Standard | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ice T | Drug | Ice/Tylenol/Toradol with dilaudid for breakthrough |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scores (VAS) | Visual Analog Scores (VAS) Scores in the morning of post op day 1. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm. | Visual Analog Scores (VAS) Score in the morning of post op day 1 at 7am. |
| Measure | Description | Time Frame |
|---|---|---|
| VAS Scores at 4 Hours Post Surgery | VAS Scores at 4 hours post surgery. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm. |
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Inclusion Criteria:
The inclusion criteria are the following:
Consenting, English speaking women between ages 18 and 80 who will undergo same day vaginal female pelvic reconstructive surgery at MetroHealth Medical Center
Ability to read VAS Scores
Specific vaginal procedures include, but are not limited to:
Exclusion Criteria:
Only patients who undergo same day (<24 hour) female pelvic reconstructive surgery
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31201808 | Derived | Petrikovets A, Sheyn D, Sun HH, Chapman GC, Mahajan ST, Pollard RR, El-Nashar SA, Hijaz AK, Mangel J. Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial. Am J Obstet Gynecol. 2019 Nov;221(5):511.e1-511.e10. doi: 10.1016/j.ajog.2019.06.002. Epub 2019 Jun 12. |
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138 Patients assessed for eligibility. 72 patients excluded: 55 not meeting inclusion criteria and 17 declined to participate.
66 were randomized.
Study approved January 30th, 2017. First patient recruited April 2017. Between April 2017 and April 2018, 138 women who were scheduled for surgery were assessed. 72 patients were excluded. Sixty-six patients were randomized to the ICE-T or Standard protocols. Of the 33 patients who were randomized to the ICE-T regimen, three were excluded after randomization. Ultimately, thirty patients in the ICE-T arm and 33 patients in the Standard arm were analyzed.
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| ID | Title | Description |
|---|---|---|
| FG000 | ICE T Postoperative Pain Regimen |
Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough |
| FG001 | Standard Postoperative Pain Regimen |
Motrin/Percocet/Dilaudid for breakthrough: Standard regimen |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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There were 66 total patients that were randomized. 3 patients were excluded from the ICE-T arm whereas non were excluded from the Standard arm. 30 patients analyzed in the ICE-T arm and 33 patients in the Standard arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | ICE T | • At the end of surgery patients receive 30mg of IV ketorolac. Once out of PACU patients receive:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Visual Analog Scores (VAS) | Visual Analog Scores (VAS) Scores in the morning of post op day 1. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm. | Posted | Median | Inter-Quartile Range | mm | Visual Analog Scores (VAS) Score in the morning of post op day 1 at 7am. |
|
Each patient was assessed for adverse events during the course of the entire study extending one month after completion of recruitment to allow for one month after surgery for each patient recruited.
An independent data and safety monitoring physician in the Department of Obstetrics and Gynecology at both institutions oversaw the progress of the study.
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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 T |
Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrey Petrikovets MD | UH Hospitals Cleveland Medical Center/MetroHealth Medical Center at time of study protocol | 323 243 9091 | andrepetrikovets@yahoo.com |
| Type | Description | Creation Date | Issued Date | Release Date | Posted Date |
|---|---|---|---|---|---|
| Correction Confirmed by FDA | The responsible party has corrected the violation. | Jan 5, 2022 | Dec 20, 2021 | Oct 3, 2021 | Jan 6, 2022 |
| Violation Identified by FDA | Failure to Submit. The entry for this clinical trial was not complete at the time of submission, as required by law. This may or may not have any bearing on the accuracy of the information in the entry. | Sep 2, 2021 | Aug 31, 2021 | Dec 15, 2018 | Sep 3, 2021 |
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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 | Sep 9, 2016 | Oct 3, 2021 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Motrin/Percocet/Dilaudid for breakthrough |
| Drug |
Standard regimen |
|
| VAS Scores at 4 hours post surgery |
| VAS Scores 96 Hours After Surgery | VAS Scores 96 hours after surgery. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm. | VAS Scores 96 hours after surgery |
| Quality of Recovery Scores on Post op Day 1 | Quality of Recovery scores on post op day 1. The QoR-40 is a 40-item quality of recovery score measuring 5 dimensions: physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is rated on a 5-point Likert scale. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). It was specifically designed to measure a patient's health status after surgery and anesthesia, and it has been proposed as a measure of outcome in clinical trials. | Quality of Recovery scores on post op day 1 |
| Satisfaction Scores in the Morning After Surgery (7AM) | Satisfaction scores in the morning after surgery (7AM). The satisfaction score is a numerical score from 0-10 with a score of 0 indicating very dissatisfied on the left of the scale and 10 indicating very satisfied on the right of the scale. | Satisfaction scores in the morning after surgery (7AM) |
| Satisfaction Scores 96 Hours After Surgery | Satisfaction scores 96 hours after surgery. The satisfaction score is a numerical score from 0-10 with a score of 0 indicating very dissatisfied on the left of the scale and 10 indicating very satisfied on the right of the scale. | Satisfaction scores 96 hours after surgery |
| Length of Stay | Length of time from the end of surgery to discharge home from the hospital, assessed up to 1 week. | Time from end of surgery to discharge home from hospital, assessed up to 1 week. |
| Total Dose of Opioids Administered During Hospitalization | Total dose of opioids administered during hospitalization in morphine equivalents upon hospital discharge. | Total dose of opioids administered during hospitalization in morphine equivalents from the end of surgery to discharge up to 1 week |
| Postoperative Nausea and Vomiting at 7AM After Surgery | Number of patients with postoperative nausea and vomiting at 7AM after surgery | Postoperative nausea and vomiting from the time to end of surgery until 7AM after surgery |
| Number of Participants With Urinary Retention. | Number of participants with urinary retention (discharge home with foley) | Number of participants with urinary retention (discharge home with foley) measured on day patient is discharged home/study completion up to 1 week. |
| BG001 | STANDARD | • At the end of surgery patients receive 30mg of IV ketorolac. Once out of PACU patients receive:
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Standard |
Motrin/Percocet/Dilaudid for breakthrough: Standard regimen |
|
|
| Secondary | VAS Scores at 4 Hours Post Surgery | VAS Scores at 4 hours post surgery. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm. | Posted | Median | Inter-Quartile Range | mm | VAS Scores at 4 hours post surgery |
|
|
|
| Secondary | VAS Scores 96 Hours After Surgery | VAS Scores 96 hours after surgery. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm. | Posted | Median | Inter-Quartile Range | mm | VAS Scores 96 hours after surgery |
|
|
|
| Secondary | Quality of Recovery Scores on Post op Day 1 | Quality of Recovery scores on post op day 1. The QoR-40 is a 40-item quality of recovery score measuring 5 dimensions: physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is rated on a 5-point Likert scale. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). It was specifically designed to measure a patient's health status after surgery and anesthesia, and it has been proposed as a measure of outcome in clinical trials. | Posted | Median | Inter-Quartile Range | score on a scale | Quality of Recovery scores on post op day 1 |
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|
| Secondary | Satisfaction Scores in the Morning After Surgery (7AM) | Satisfaction scores in the morning after surgery (7AM). The satisfaction score is a numerical score from 0-10 with a score of 0 indicating very dissatisfied on the left of the scale and 10 indicating very satisfied on the right of the scale. | Posted | Median | Inter-Quartile Range | score on a scale | Satisfaction scores in the morning after surgery (7AM) |
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| Secondary | Satisfaction Scores 96 Hours After Surgery | Satisfaction scores 96 hours after surgery. The satisfaction score is a numerical score from 0-10 with a score of 0 indicating very dissatisfied on the left of the scale and 10 indicating very satisfied on the right of the scale. | Posted | Median | Inter-Quartile Range | score on a scale | Satisfaction scores 96 hours after surgery |
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| Secondary | Length of Stay | Length of time from the end of surgery to discharge home from the hospital, assessed up to 1 week. | Posted | Mean | Standard Deviation | hours | Time from end of surgery to discharge home from hospital, assessed up to 1 week. |
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| Secondary | Total Dose of Opioids Administered During Hospitalization | Total dose of opioids administered during hospitalization in morphine equivalents upon hospital discharge. | Posted | Mean | Standard Deviation | milligrams of oral morphine equivalents | Total dose of opioids administered during hospitalization in morphine equivalents from the end of surgery to discharge up to 1 week |
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| Secondary | Postoperative Nausea and Vomiting at 7AM After Surgery | Number of patients with postoperative nausea and vomiting at 7AM after surgery | Posted | Count of Participants | Participants | No | Postoperative nausea and vomiting from the time to end of surgery until 7AM after surgery |
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| Secondary | Number of Participants With Urinary Retention. | Number of participants with urinary retention (discharge home with foley) | Posted | Count of Participants | Participants | Number of participants with urinary retention (discharge home with foley) measured on day patient is discharged home/study completion up to 1 week. |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Standard |
Motrin/Percocet/Dilaudid for breakthrough: Standard regimen | 0 | 33 | 0 | 33 | 0 | 33 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |