Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

ICE T for Post GYN Surgery Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03987022
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Robert Pollard, MD, MetroHealth Medical Center

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.

Condition or disease Intervention/treatment Phase
Opioid Substitution Treatment Drug: Ketorolac Drug: Opioids Other: Ice Packs Drug: Tylenol Drug: Motrin Drug: dilaudid Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: "ICE-T" Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Laparoscopic Gynecologic Surgery: a Randomized Controlled Trial
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
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).
Drug: Ketorolac
Use of non-steroidal anti-inflammatory drug for pain control post operatively
Other Name: Toradol

Other: Ice Packs
Placement of Ice packs on surgical sites post operatively

Drug: Tylenol
Use of pain medication post operatively

Drug: dilaudid
Use of narcotic for pain control post operatively

Active Comparator: Standard of care

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 post operatively
Other Name: Oxycodone

Drug: Motrin
Use of non-steroidal anti-inflammatory drug for pain control post operatively

Drug: dilaudid
Use of narcotic for pain control post operatively




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. VAS Scores [ Time Frame: VAS Scores at 4 and 12 hours post surgery ]
    Visual Analog Scores at 4 and 12 hours post surgery. The scale is from 0 to 10 (0=no pain and 10=being worst pain ever)

  2. Length of stay [ Time Frame: Total length of hospitalization in days ]
    Length of hospital stay in number of days

  3. Total dose of opioid [ Time Frame: Total opioid use up to post op day 4 ]
    Total amount of opioids in morphine equivalents

  4. Incidence of urinary retention [ Time Frame: Up to post op day 4 ]
    Incidence of urinary retention

  5. Time to first bowel movement [ Time Frame: Up to post op day 4 ]
    Time to first bowel movement in days



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987022


Contacts
Layout table for location contacts
Contact: Ryan Darvish, MD 2167784444 rdarvish@metrohealth.org
Contact: Robert Pollard, MD 2167784444 rpollard@metrohealth.org

Locations
Layout table for location information
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Ryan Darvish, MD    216-778-4444    rdarvish@metrohealth.org   
Sponsors and Collaborators
MetroHealth Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Robert Pollard, MD MetroHealth Medical Center

Additional Information:
Layout table for additonal information
Responsible Party: Robert Pollard, MD, Assistant Professor of Reproductive Biology, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT03987022     History of Changes
Other Study ID Numbers: IRB18-00920
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Robert Pollard, MD, MetroHealth Medical Center:
Anti-inflammatory agents non-steroidal
Additional relevant MeSH terms:
Layout table for MeSH terms
Acetaminophen
Ketorolac
Ketorolac Tromethamine
Ibuprofen
Analgesics, Opioid
Hydromorphone
Anti-Inflammatory Agents
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipyretics