Skip to main content
OpenTrials
Completed

NCT Number: NCT03987022

ICE-T Pain Regimen for Total Laparoscopic Hysterectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Opioid Substitution Treatment

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac

Drug

Use of non-steroidal anti-inflammatory drug for pain control postoperatively

Other names: Toradol

Opioids

Drug

Use of narcotic for pain control postoperatively

Other names: Oxycodone

Ice Packs

Other

Placement of Ice packs on surgical sites postoperatively

Tylenol

Drug

Use of pain medication postoperatively

Other names: Acetaminophen

Motrin

Drug

Use of non-steroidal anti-inflammatory drug for pain control postoperatively

Other names: Ibuprofen

Dilaudid Injectable Product

Drug

Use of narcotic for pain control postoperatively

Other names: Hydromorphone

Percocet 5Mg-325Mg Tablet

Drug

Use of combination tablet of Tylenol and Oxycodone for pain control postoperatively

Other names: Oxycodone-Acetaminophen

Primary outcomes

  1. POD1 Visual Analog Pain (VAS) Score

    Time frame: Morning of post operative day 1 (~24 hours after surgery)

    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)

Secondary outcomes

  1. POD1 Quality of Recovery Score

    Time frame: Postoperative Day 1

    QoR-40 is a quality of recovery 40-item questionnaire based on how the patient has felt in the past 24 hours. It provides a global score and sub scores across five dimensions: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). It is a measure of postoperative quality of recovery in a range of clinical and research situations.

  2. 1st 24hr Total Dose of Narcotic

    Time frame: Total narcotic use from intra-op to 24 hours post-op

    Total amount of narcotic in morphine equivalents administered to patients who were admitted for overnight extended recovery and/or observation. This includes narcotics given intra-operatively, in the post-anesthesia care unit and during their inpatient stay up until 24 hours postop.

  3. Length of Stay

    Time frame: Post-operative Day 1

    Length of hospital stay measured in the number of nights spent at the hospital. Subjects were given the option for same-day discharge home from the PACU or overnight inpatient observation.

  4. POD4 VAS Scores

    Time frame: VAS Scores at 4 days post-surgery.

    Visual Analog Scores 4 days post-surgery. VAS pain score of 0 to a score of worst pain indicating a score of 10 (0=no pain and 10=being worst pain ever)

  5. POD4 Quality of Recovery

    Time frame: Postoperative Day 4

    QoR-40 is a quality of recovery 40-item questionnaire based on how the patient has felt in the past 24 hours. It provides a global score and sub scores across five dimensions: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). It is a measure of postoperative quality of recovery in a range of clinical and research situations.

  6. POD4 Satisfaction Score

    Time frame: Data collected as of postoperative day 4

    Patient's satisfaction with their pain management as of postoperative day 4, rated on a scale of 1 - 10, where 1 is very dissatisfied and 10 is very satisfied.

  7. Time to First Bowel Movement

    Time frame: Up to post op day 4

    Time to first bowel movement in days

  8. Oxycodone 5mg Doses Taken Since Discharge

    Time frame: Data collected as of Postoperative day 4

    The number of oxycodone 5mg doses (whether as oxycodone 5mg or as percocet 5/325) taken since discharge up until postoperative 4.

Other outcomes

  1. "ICE-T" Arm Patients Who Requested Supplemental Narcotics in Addition to Their ICE-T Regimen

    Time frame: Up until postoperative day 4

    Enrolled patients were randomized at the end of surgery 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.

Sponsors and collaborators

Lead sponsor

MetroHealth Medical Center

Other

Registry information

Official study title

"ICE-T" Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Laparoscopic Gynecologic Surgery: a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 14, 2019
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.