Opioid Substitution Treatment Clinical Trial
Official title:
"ICE-T" Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Laparoscopic Gynecologic Surgery: a Randomized Controlled Trial
Verified date | April 2022 |
Source | MetroHealth Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this randomized controlled trial is to determine whether, "ICE-T," a multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and tylenol, has improved pain control compared to the standard narcotic based postoperative pain regimen in patients undergoing total laparoscopic gyn surgery.
Status | Completed |
Enrollment | 66 |
Est. completion date | April 25, 2022 |
Est. primary completion date | April 25, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: The inclusion criteria are the following: - Consenting, English speaking women between ages 18 and 80 who will undergo same day laparoscopic gyn surgery at MetroHealth Medical Center - Ability to read VAS Scores - Specific procedures include, but are not limited to: - Laparoscopic hysterectomy, for uterus 250 g or less - Laparoscopic hysterectomy, for uterus 250 g or less; with removal of tube(s), and/or ovary(s) - Laparoscopic hysterectomy, for uterus 250 g or less; with removal of tube(s), and/or ovary(s), with repair of enterocele - Laparoscopic hysterectomy, for uterus 250 g or less; with repair of enterocele - Laparoscopic hysterectomy, for uterus greater than 250 g - Laparoscopic hysterectomy, for uterus greater than 250 g; with removal of tube(s) and/or ovary(s) - Laparoscopic hysterectomy, for uterus greater than 250 g; with removal of tube(s) and/or ovary(s), with repair of enterocele - Laparoscopic hysterectomy, for uterus greater than 250 g; with repair of enterocele Exclusion Criteria: - History of chronic pelvic pain - Abdominal 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 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 |
Country | Name | City | State |
---|---|---|---|
United States | MetroHealth Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
MetroHealth Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual analog pain (VAS) score | Visual Analog Scores (VAS) Scores in the morning of post op day 1 (~24 hours after surgery) The scale is from 0 to 10 (0=no pain and 10=being worst pain ever) | Morning of post operative day 1 (~24 hours after surgery) | |
Secondary | VAS Scores | Visual Analog Scores at 4 and 12 hours post surgery. The scale is from 0 to 10 (0=no pain and 10=being worst pain ever) | VAS Scores at 4 and 12 hours post surgery | |
Secondary | Length of stay | Length of hospital stay in number of days | Total length of hospitalization in days | |
Secondary | Total dose of opioid | Total amount of opioids in morphine equivalents | Total opioid use up to post op day 4 | |
Secondary | Incidence of urinary retention | Incidence of urinary retention | Up to post op day 4 | |
Secondary | Time to first bowel movement | Time to first bowel movement in days | Up to post op day 4 |
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