ICE-T Pain Regimen for Total Laparoscopic Hysterectomy

NCT03987022 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB18-00920
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Substitution Treatment

Keywords

Anti-inflammatory agents non-steroidal

Outcome Measures

Primary Outcomes (1)

• POD1 Visual Analog Pain (VAS) Score

  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)

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

Secondary Outcomes (8)

• POD1 Quality of Recovery Score

  Postoperative Day 1

• 1st 24hr Total Dose of Narcotic

  Total narcotic use from intra-op to 24 hours post-op

• Length of Stay

  Post-operative Day 1

• POD4 VAS Scores

  VAS Scores at 4 days post-surgery.

• POD4 Quality of Recovery

  Postoperative Day 4

Other Outcomes (1)

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

  Up until postoperative day 4

Study Arms (2)

"ICE-T"

EXPERIMENTAL

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; Drug: Opioids; Other: Ice Packs; Drug: Tylenol; Drug: Dilaudid Injectable Product

Standard of Care (Control)

ACTIVE COMPARATOR

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; Drug: Motrin; Drug: Dilaudid Injectable Product; Drug: Percocet 5Mg-325Mg Tablet

Interventions

Ketorolac DRUG

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

Also known as: Toradol

"ICE-T"

Opioids DRUG

Use of narcotic for pain control postoperatively

Also known as: Oxycodone

"ICE-T"; Standard of Care (Control)

Ice Packs OTHER

Placement of Ice packs on surgical sites postoperatively

"ICE-T"

Tylenol DRUG

Use of pain medication postoperatively

Also known as: Acetaminophen

"ICE-T"

Motrin DRUG

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

Also known as: Ibuprofen

Standard of Care (Control)

Dilaudid Injectable Product DRUG

Use of narcotic for pain control postoperatively

Also known as: Hydromorphone

"ICE-T"; Standard of Care (Control)

Percocet 5Mg-325Mg Tablet DRUG

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

Also known as: Oxycodone-Acetaminophen

Standard of Care (Control)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Links

• Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial

MeSH Terms

Interventions

Ketorolac; Ketorolac Tromethamine; Analgesics, Opioid; Oxycodone; Acetaminophen; Ibuprofen; Hydromorphone; oxycodone-acetaminophen

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Results Point of Contact

• Title: Dr. Robert Pollard
• Organization: Metrohealth System

rpollard@metrohealth.org

2167781446

Study Officials

• Robert Pollard, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Reproductive Biology

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 14, 2019
• Study Start: August 1, 2019
• Primary Completion: April 25, 2022
• Study Completion: April 25, 2022
• Last Updated: January 24, 2025
• Results First Posted: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)