ICE T for Post GYN Surgery Pain

Opioid Substitution Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03987022
• Other study ID #: IRB18-00920
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2019
• Est. completion date: April 25, 2022

Study information

• Verified date: April 2022
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 25, 2022
• Est. primary completion date: April 25, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Substitution Treatment

Intervention

Drug:
• Ketorolac
Use of non-steroidal anti-inflammatory drug for pain control post operatively
• Opioids
Use of narcotic for pain control post operatively

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

Drug:
• Tylenol
Use of pain medication post operatively
• Motrin
Use of non-steroidal anti-inflammatory drug for pain control post operatively
• dilaudid
Use of narcotic for pain control post operatively

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	VAS Scores	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)	VAS Scores at 4 and 12 hours post surgery
Secondary	Length of stay	Length of hospital stay in number of days	Total length of hospitalization in days
Secondary	Total dose of opioid	Total amount of opioids in morphine equivalents	Total opioid use up to post op day 4
Secondary	Incidence of urinary retention	Incidence of urinary retention	Up to post op day 4
Secondary	Time to first bowel movement	Time to first bowel movement in days	Up to post op day 4

External Links

•   ICE-T postoperative multimodal pain regimen compared to the standard regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial