ICE-T Pain Regimen for Total Laparoscopic Hysterectomy

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2022-04-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Opioid Substitution Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

NONE

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.

Study Groups

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"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).
6. If patients requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control

Group Type EXPERIMENTAL

Ketorolac

Intervention Type DRUG

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

Opioids

Intervention Type DRUG

Use of narcotic for pain control postoperatively

Ice Packs

Intervention Type OTHER

Placement of Ice packs on surgical sites postoperatively

Tylenol

Intervention Type DRUG

Use of pain medication postoperatively

Dilaudid Injectable Product

Intervention Type DRUG

Use of narcotic for pain control postoperatively

Standard of Care (Control)

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.

Group Type ACTIVE_COMPARATOR

Opioids

Intervention Type DRUG

Use of narcotic for pain control postoperatively

Motrin

Intervention Type DRUG

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

Dilaudid Injectable Product

Intervention Type DRUG

Use of narcotic for pain control postoperatively

Percocet 5Mg-325Mg Tablet

Intervention Type DRUG

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

Interventions

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Ketorolac

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

Intervention Type DRUG

Opioids

Use of narcotic for pain control postoperatively

Intervention Type DRUG

Ice Packs

Placement of Ice packs on surgical sites postoperatively

Intervention Type OTHER

Tylenol

Use of pain medication postoperatively

Intervention Type DRUG

Motrin

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

Intervention Type DRUG

Dilaudid Injectable Product

Use of narcotic for pain control postoperatively

Intervention Type DRUG

Percocet 5Mg-325Mg Tablet

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

Intervention Type DRUG

Other Intervention Names

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Toradol Oxycodone Acetaminophen Ibuprofen Hydromorphone Oxycodone-Acetaminophen

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No