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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
"ICE-T" 		Regimen #1 "ICE-T" Opioid Sparing Regimen At the end of surgery patients will receive 30mg of intravenous (IV) toradol. Once out of the post anesthesia care unit (PACU) patients will receive ICE PACKS applied to the surgical sites every hour for 20 minutes Around the clock (ATC) until discharge. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge. Once out of the PACU will receive 1 gram of Tylenol per os (PO) every 6 hours for a total of 4 grams daily ATC until discharge Patients will receive dilaudid 0.2mg IV every 3 hours as needed (PRN) for breakthrough pain. Patients will be discharged home with (PO) Tylenol and PO toradol as needed (PRN).
  • Drug: Ketorolac
    Use of non-steroidal anti-inflammatory drug for pain control post operatively
    Other names:
    • Toradol
  • Other: Ice Packs
    Placement of Ice packs on surgical sites post operatively
  • Drug: Tylenol
    Use of pain medication post operatively
  • Drug: dilaudid
    Use of narcotic for pain control post operatively
Active Comparator
Standard of care 		Regimen #2 STANDARD Postoperative Regimen Once out of the PACU patients will receive "Standard" postoperative regimen Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain. Patients will be discharged home with Motrin and Percocet for pain PRN.
  • Drug: Opioids
    Use of narcotic for pain control post operatively
    Other names:
    • Oxycodone
  • Drug: Motrin
    Use of non-steroidal anti-inflammatory drug for pain control post operatively
  • Drug: dilaudid
    Use of narcotic for pain control post operatively

Recruiting Locations

MetroHealth Medical Center
Cleveland, Ohio 44109
Contact:
Ryan Darvish, MD
216-778-4444
rdarvish@metrohealth.org

More Details

Status
Recruiting
Sponsor
MetroHealth Medical Center

Study Contact

Ryan Darvish, MD
2167784444
rdarvish@metrohealth.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.