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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 Sex
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
Intervention Model Description
Enrolled patients were randomized at the end of surgery using sequentially numbered opaque sealed envelopes. A statistician developed the 1:1 mixed block randomization sequence using a random number generator; only the statistician was aware of the sequence. They were randomized to 1 of 2 postoperative pain regimens: ICE-T opioid-sparing regimen or the Standard opioid-centric regimen. The pain regimen protocols began upon PACU discharge. Subjects received their regimens as assigned, except that patients assigned to the ICE-T opioid-sparing group who requested additional narcotic medications prior to postoperative day 4 were prescribed supplemental opioids in addition to their ICE-T regimen medications.
Primary Purpose
Other
Masking
None (Open Label)
Masking Description
The randomized sequence was masked to all except the statistician who developed the sequence. Upon randomization, the participants, care providers, investigators and outcome assessors were aware of the participant study arm allocations.

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 1. ICE PACKS applied to the surgical sites every hour for 20 minutes Around the clock (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 per os (PO) every 6 hours for a total of 4 grams daily ATC until discharge 4. Patients will receive dilaudid 0.2mg IV every 3 hours as needed (PRN) for breakthrough pain. 5. Patients will be discharged home with (PO) Tylenol and PO toradol as needed (PRN). 6. If patients requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control
  • Drug: Ketorolac
    Use of non-steroidal anti-inflammatory drug for pain control postoperatively
    Other names:
    • Toradol
  • Drug: Opioids
    Use of narcotic for pain control postoperatively
    Other names:
    • Oxycodone
  • Other: Ice Packs
    Placement of Ice packs on surgical sites postoperatively
  • Drug: Tylenol
    Use of pain medication postoperatively
    Other names:
    • Acetaminophen
  • Drug: Dilaudid Injectable Product
    Use of narcotic for pain control postoperatively
    Other names:
    • Hydromorphone
Active Comparator
Standard of Care (Control) 		Regimen #2 STANDARD Postoperative Regimen 1. Once out of the PACU patients will receive "Standard" postoperative regimen 2. Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain 3. Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain 4. Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain 5. Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain. 6. Patients will be discharged home with Motrin and Percocet for pain PRN.
  • Drug: Opioids
    Use of narcotic for pain control postoperatively
    Other names:
    • Oxycodone
  • Drug: Motrin
    Use of non-steroidal anti-inflammatory drug for pain control postoperatively
    Other names:
    • Ibuprofen
  • Drug: Dilaudid Injectable Product
    Use of narcotic for pain control postoperatively
    Other names:
    • Hydromorphone
  • Drug: Percocet 5Mg-325Mg Tablet
    Use of combination tablet of Tylenol and Oxycodone for pain control postoperatively
    Other names:
    • Oxycodone-Acetaminophen

More Details

Status
Completed
Sponsor
MetroHealth Medical Center

Study Contact

Detailed Description

Laparoscopy is a frequently used route for hysterectomy. Yet few studies have investigated opioid-sparing postoperative regimens for this common surgery. The study objective was to determine whether ice packs, Tylenol, and Toradol (ICE-T), an opioid-sparing multimodal postoperative pain regimen, has improved pain control compared with a standard opioid-centric postoperative pain regimen in total laparoscopic hysterectomy patients. The study was a randomized controlled trial. It included total laparoscopic hysterectomy postoperative patients that were randomized to the ICE-T or standard regimen. The ICE-T regimen prescribed scheduled around-the-clock ice-packs, acetaminophen and ketorolac. The standard protocol prescribed as needed ibuprofen and acetaminophen/oxycodone based on pain score. Both regimens included intravenous hydromorphone for breakthrough pain. However, subjects in the ICE-T group who requested additional narcotic medications prior to postoperative day 4, were prescribed supplemental narcotics in addition to the ICE-T regimen. The subjects pain control and quality of recovery were assessed on postoperative day 1 and 4.

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.