Pain, Postoperative, Pelvic Organ Prolapse
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGIce T
Ice/Tylenol/Toradol with dilaudid for breakthrough
DRUGMotrin/Percocet/Dilaudid for breakthrough
Standard regimen
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
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: * Periurethral bulking * Perineoplasty * Complete vaginectomy * Le Forte colpocleisis * Anterior repair * Posterior repair * Enterocele repair * Anterior and posterior repair * Anterior, posterior and enterocele repair * Transvaginal mesh use * Sacrospinous ligament fixation * Uterosacral ligament suspension * Vaginal paravaginal defect repair * Midurethral Sling * Sphincteroplasty * Vaginal hysterectomy, for uterus 250 g or less * Vaginal hysterectomy, for uterus 250 g or less; with removal of tube(s), and/or ovary(s) * Vaginal hysterectomy, for uterus 250 g or less; with removal of tube(s), and/or ovary(s), with repair of enterocele * Vaginal hysterectomy, for uterus 250 g or less; with repair of enterocele * Vaginal hysterectomy, for uterus greater than 250 g * Vaginal hysterectomy, for uterus greater than 250 g; with removal of tube(s) and/or ovary(s) * Vaginal hysterectomy, for uterus greater than 250 g; with removal of tube(s) and/or ovary(s), with repair of enterocele * Vaginal hysterectomy, for uterus greater than 250 g; with repair of enterocele
Exclusion criteria
* The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scores (VAS) | Visual Analog Scores (VAS) Score in the morning of post op day 1 at 7am. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS Scores 96 Hours After 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. |
| Quality of Recovery Scores on Post op Day 1 | 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. |
| Satisfaction Scores in the Morning After Surgery (7AM) | 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 96 Hours After Surgery | 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. |
| VAS Scores at 4 Hours Post Surgery | 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. |
| Total Dose of Opioids Administered During Hospitalization | Total dose of opioids administered during hospitalization in morphine equivalents from the end of surgery to discharge up to 1 week | Total dose of opioids administered during hospitalization in morphine equivalents upon hospital discharge. |
| 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 patients with postoperative nausea and vomiting at 7AM after surgery |
| Number of Participants With Urinary Retention. | Number of participants with urinary retention (discharge home with foley) measured on day patient is discharged home/study completion up to 1 week. | Number of participants with urinary retention (discharge home with foley) |
| Length of Stay | Time from end of surgery to discharge home from hospital, assessed up to 1 week. | Length of time from the end of surgery to discharge home from the hospital, assessed up to 1 week. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
138 Patients assessed for eligibility. 72 patients excluded: 55 not meeting inclusion criteria and 17 declined to participate. 66 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| ICE T • At the end of surgery patients receive 30mg of IV ketorolac.
Once out of PACU patients receive:
* ICE PACKS applied to the perineum Q2h for 20 minutes ATC until discharge
* Ketorolac 30mg IV Q6h ATC until discharge
* Acetaminophen 1g PO Q6h ATC until discharge
* Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain
* Patients are discharged home with:
1. Acetaminophen 1 gram PO every 6 hours PRN pain 1-5 #60
2. Ketorolac 10mg PO every 6 hours PRN pain #6-10 #16 | 30 |
| STANDARD • At the end of surgery patients receive 30mg of IV ketorolac.
Once out of PACU patients receive:
* Ibuprofen 600mg PO Q4h PRN pain 1-3
* Acetaminophen/oxycodone 5mg/325mg 1 tablet PO Q4-6h PRN pain 4-6
* Acetaminophen/oxycodone 5mg/325mg 2 tablets PO Q4-6h PRN pain 7-10
* Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain
* Patients are discharged home with:
1. Ibuprofen 600mg PO Q8h PRN pain 1-5 #60
2. Acetaminophen/oxycodone 5mg/325mg 1-2 tablets Q4-6h PRN pain 6-10 #16 | 33 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Desired opioids | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | ICE T | STANDARD |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 10 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 20 Participants | 21 Participants |
| Age, Continuous | 60.7 years STANDARD_DEVIATION 11.4 | 61.8 years STANDARD_DEVIATION 10.1 | 59.8 years STANDARD_DEVIATION 12.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 48 Participants | 20 Participants | 28 Participants |
| Region of Enrollment United States | 63 participants | 30 participants | 33 participants |
| Sex: Female, Male Female | 63 Participants | 30 Participants | 33 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 / 30 | 0 / 33 |
| other Total, other adverse events | 0 / 30 | 0 / 33 |
| serious Total, serious adverse events | 0 / 30 | 0 / 33 |
Outcome results
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.
Time frame: Visual Analog Scores (VAS) Score in the morning of post op day 1 at 7am.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ICE T | Visual Analog Scores (VAS) | 20 mm |
| Standard | Visual Analog Scores (VAS) | 40 mm |
Secondary
Length of Stay
Length of time from the end of surgery to discharge home from the hospital, assessed up to 1 week.
Time frame: Time from end of surgery to discharge home from hospital, assessed up to 1 week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ICE T | Length of Stay | 24.1 hours | Standard Deviation 3.1 |
| Standard | Length of Stay | 24.1 hours | Standard Deviation 5.4 |
Secondary
Number of Participants With Urinary Retention.
Number of participants with urinary retention (discharge home with foley)
Time frame: Number of participants with urinary retention (discharge home with foley) measured on day patient is discharged home/study completion up to 1 week.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ICE T | Number of Participants With Urinary Retention. | 5 Participants |
| Standard | Number of Participants With Urinary Retention. | 7 Participants |
Secondary
Postoperative Nausea and Vomiting at 7AM After Surgery
Number of patients with postoperative nausea and vomiting at 7AM after surgery
Time frame: Postoperative nausea and vomiting from the time to end of surgery until 7AM after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ICE T | Postoperative Nausea and Vomiting at 7AM After Surgery | 14 Participants |
| Standard | Postoperative Nausea and Vomiting at 7AM After Surgery | 18 Participants |
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.
Time frame: Quality of Recovery scores on post op day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ICE T | Quality of Recovery Scores on Post op Day 1 | 182 score on a scale |
| Standard | Quality of Recovery Scores on Post op Day 1 | 173 score on a scale |
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.
Time frame: Satisfaction scores 96 hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ICE T | Satisfaction Scores 96 Hours After Surgery | 10 score on a scale |
| Standard | Satisfaction Scores 96 Hours After Surgery | 9 score on a scale |
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.
Time frame: Satisfaction scores in the morning after surgery (7AM)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ICE T | Satisfaction Scores in the Morning After Surgery (7AM) | 10 score on a scale |
| Standard | Satisfaction Scores in the Morning After Surgery (7AM) | 10 score on a scale |
Secondary
Total Dose of Opioids Administered During Hospitalization
Total dose of opioids administered during hospitalization in morphine equivalents upon hospital discharge.
Time frame: Total dose of opioids administered during hospitalization in morphine equivalents from the end of surgery to discharge up to 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ICE T | Total Dose of Opioids Administered During Hospitalization | 55.7 milligrams of oral morphine equivalents | Standard Deviation 31.2 |
| Standard | Total Dose of Opioids Administered During Hospitalization | 91.2 milligrams of oral morphine equivalents | Standard Deviation 38.9 |
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.
Time frame: VAS Scores 96 hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ICE T | VAS Scores 96 Hours After Surgery | 20 mm |
| Standard | VAS Scores 96 Hours After Surgery | 30 mm |
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.
Time frame: VAS Scores at 4 hours post surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ICE T | VAS Scores at 4 Hours Post Surgery | 35 mm |
| Standard | VAS Scores at 4 Hours Post Surgery | 50 mm |