ICE T for Post GYN Surgery Pain
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
- Opioid Substitution Treatment
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
Arm | Description | Assigned 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). |
|
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. |
|
More Details
- Status
- Completed
- Sponsor
- MetroHealth Medical Center