Clinical trial NCT03987022: ICE-T Pain Regimen for Total Laparoscopic Hysterectomy
Official title: "ICE-T" Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Laparoscopic Gynecologic Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid Substitution Treatment
Keywords: Anti-inflammatory agents non-steroidal
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: POD1 Visual Analog Pain (VAS) Score
timeFrame: Morning of post operative day 1 (~24 hours after surgery)
Secondary outcomes:
measure: POD1 Quality of Recovery Score
timeFrame: Postoperative Day 1
measure: 1st 24hr Total Dose of Narcotic
timeFrame: Total narcotic use from intra-op to 24 hours post-op
measure: Length of Stay
timeFrame: Post-operative Day 1
measure: POD4 VAS Scores
timeFrame: VAS Scores at 4 days post-surgery.
measure: POD4 Quality of Recovery
timeFrame: Postoperative Day 4
measure: POD4 Satisfaction Score
timeFrame: Data collected as of postoperative day 4
measure: Time to First Bowel Movement
timeFrame: Up to post op day 4
measure: Oxycodone 5mg Doses Taken Since Discharge
timeFrame: Data collected as of Postoperative day 4
Other outcomes:
measure: "ICE-T" Arm Patients Who Requested Supplemental Narcotics in Addition to Their ICE-T Regimen
timeFrame: Up until postoperative day 4
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: MetroHealth Medical Center
name: Robert Pollard, MD
role: PRINCIPAL_INVESTIGATOR
References: