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Trial record 1 of 1 for:    NCT03052816
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Ice T Postoperative Multimodal Pain Regimen in FPMRS Surgery (ICET)

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ClinicalTrials.gov Identifier: NCT03052816
Recruitment Status : Completed
First Posted : February 14, 2017
Results First Posted : October 6, 2021
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
Andrey Petrikovets, Case Western Reserve University

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Pelvic Organ Prolapse Drug: Ice T Drug: Motrin/Percocet/Dilaudid for breakthrough Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ICE-T Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Same Day Vaginal Pelvic Reconstructive Surgery: a Randomized Controlled Trial
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ICE T
  1. ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge.
  2. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
  3. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge
  4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
  5. Patients will be discharged home with PO Tylenol and PO toradol PRN.
Drug: Ice T
Ice/Tylenol/Toradol with dilaudid for breakthrough

Active Comparator: Standard
  1. Motrin 600mg PO Q4h PRN pain 1-3
  2. Percocet 1 tab PO Q4-6 hours PRN 4-6 pain
  3. Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain
  4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
  5. Patients will be discharged home with Motrin and Percocet for pain PRN.
Drug: Motrin/Percocet/Dilaudid for breakthrough
Standard regimen




Primary Outcome Measures :
  1. Visual Analog Scores (VAS) [ Time Frame: 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 Outcome Measures :
  1. VAS Scores at 4 Hours Post Surgery [ 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.

  2. VAS Scores 96 Hours After Surgery [ Time Frame: 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.

  3. Quality of Recovery Scores on Post op Day 1 [ Time Frame: 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.

  4. Satisfaction Scores in the Morning After Surgery (7AM) [ Time Frame: 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.

  5. Satisfaction Scores 96 Hours After Surgery [ Time Frame: 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.

  6. Length of Stay [ Time Frame: 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.

  7. Total Dose of Opioids Administered During Hospitalization [ Time Frame: 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.

  8. 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 ]
    Number of patients with postoperative nausea and vomiting at 7AM after surgery

  9. Number of Participants With Urinary Retention. [ 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. ]
    Number of participants with urinary retention (discharge home with foley)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only patients who undergo same day (<24 hour) female pelvic reconstructive surgery
Accepts Healthy Volunteers:   Yes
Criteria

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 exclusion criteria are the following:
  • History of chronic pelvic pain
  • Abdominal surgery
  • Laparoscopic surgery
  • History of psychiatric disease
  • Currently taking analgesic medications
  • Currently taking sedatives
  • Liver disease
  • Renal disease with CrCl < 60cc/min.
  • History of burns from application of ice.
  • Women who did not consent for the study.
  • Intraoperative concern for increased blood loss
  • Unable to speak English
  • Unable to understand VAS Scores
  • Undergoing concomitant abdominal or laparoscopic procedures.
  • Allergy to motrin, toradol, Percocet, Tylenol
  • Active or history of peptic ulcer disease
  • History of GI bleeding or perforation
  • Hemorrhagic diathesis
  • Severe uncontrolled heart failure
  • Inflammatory bowel disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052816


Locations
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United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
  Study Documents (Full-Text)

Documents provided by Andrey Petrikovets, Case Western Reserve University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andrey Petrikovets, Physician, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT03052816    
Other Study ID Numbers: 16-00498
First Posted: February 14, 2017    Key Record Dates
Results First Posted: October 6, 2021
Last Update Posted: October 6, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prolapse
Pain, Postoperative
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents