Trial Outcomes & Findings for ICE-T Pain Regimen for Total Laparoscopic Hysterectomy (NCT NCT03987022)

Last Updated: 2025-01-24

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

66 participants

Primary outcome timeframe

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

Results posted on

2025-01-24

Participant Flow

Prior to surgery, patients will be asked to participate in the study in their private patient rooms or in medical clinic.

111 patients were assessed for eligibility, but 45 were excluded (30 did not meet inclusion criteria, and 15 declined to participate). Therefore, 66 patients were randomized.

Participant milestones

Participant milestones
Measure	"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).	STANDARD Postoperative Regimen Once out of the PACU patients will receive "Standard" postoperative regimen, which includes: 1. Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain 2. Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain 3. Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain 4. Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain. 5. Patients will be discharged home with Motrin and Percocet for pain PRN.
Overall Study STARTED	36	30
Overall Study COMPLETED	33	28
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	"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).	STANDARD Postoperative Regimen Once out of the PACU patients will receive "Standard" postoperative regimen, which includes: 1. Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain 2. Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain 3. Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain 4. Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain. 5. Patients will be discharged home with Motrin and Percocet for pain PRN.
Overall Study Lost to Follow-up	2	2
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

66 participants were enrolled (36 ICE-T arm; 30 Standard Care arm). The final analysis for postoperative day 1 outcomes included 60 subjects (n= 32 ICE-T arm POD1 analysis, 1 withdrew, 3 loss to follow up; n=28 Standard care arm POD1 analysis, 2 loss to follow up). The final analysis for postoperative day 4 outcomes included 52 subjects (n=29 ICE-T arm POD4 analysis, 1 withdrew, 6 loss to follow up; n=23 Standard arm POD4 analysis, 7 loss to follow up).

Baseline characteristics by cohort

PRIMARY outcome

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

Population: This population are participants that are approximately 24 hours post Total Laparoscopic Hysterectomy procedure. 66 participants were enrolled (36 ICE-T arm; 30 Standard Care arm). The final analysis for postoperative day 1 outcomes included 60 subjects (n= 32 ICE-T arm POD1 analysis, 1 withdrew, 3 loss to follow up; n=28 Standard care arm POD1 analysis, 2 loss to follow up).

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)

Outcome measures

Outcome measures
Measure	"ICE-T" Opioid Sparing Regimen n=32 Participants 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 patient's requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control	STANDARD Postoperative Regimen n=28 Participants Once out of the PACU patients will receive "Standard" postoperative regimen, which includes: 1. Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain 2. Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain 3. Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain 4. Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain. 5. Patients will be discharged home with Motrin and Percocet for pain PRN.
POD1 Visual Analog Pain (VAS) Score	5.8 Score on a scale Interval 3.0 to 7.0	5 Score on a scale Interval 3.0 to 6.0

SECONDARY outcome

Timeframe: Postoperative Day 1

Population: 66 participants were enrolled (36 ICE-T arm; 30 Standard Care arm). The final analysis for postoperative day 1 outcomes included 60 subjects (n= 32 ICE-T arm POD1 analysis, 1 withdrew, 3 loss to follow up; n=28 Standard care arm POD1 analysis, 2 loss to follow up).

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.

Outcome measures

Outcome measures
Measure	"ICE-T" Opioid Sparing Regimen n=32 Participants 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 patient's requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control	STANDARD Postoperative Regimen n=28 Participants Once out of the PACU patients will receive "Standard" postoperative regimen, which includes: 1. Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain 2. Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain 3. Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain 4. Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain. 5. Patients will be discharged home with Motrin and Percocet for pain PRN.
POD1 Quality of Recovery Score	161.5 Score on a scale Interval 147.5 to 179.0	162.5 Score on a scale Interval 155.0 to 179.5

SECONDARY outcome

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

Population: 66 participants were enrolled (36 ICE-T arm; 30 Standard Care arm). The postoperative day 1 analysis outcomes included n= 32 ICE-T arm POD1 analysis, 1 withdrew, 3 loss to follow up; n=28 Standard care arm POD1 analysis, 2 loss to follow up. The subjects who chose same-day discharge were excluded from the analysis of total narcotic use within 24 hours post-op due to differences in reporting and access to medications. The analysis of this variable included n=27 ICE-T arm and n=23 Standard arm.

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.

Outcome measures

Outcome measures
Measure	"ICE-T" Opioid Sparing Regimen n=27 Participants 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 patient's requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control	STANDARD Postoperative Regimen n=23 Participants Once out of the PACU patients will receive "Standard" postoperative regimen, which includes: 1. Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain 2. Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain 3. Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain 4. Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain. 5. Patients will be discharged home with Motrin and Percocet for pain PRN.
1st 24hr Total Dose of Narcotic	77 oral morphine milligram equivalents Interval 54.3 to 101.0	111.5 oral morphine milligram equivalents Interval 84.8 to 121.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	"ICE-T" Opioid Sparing Regimen n=32 Participants 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 patient's requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control	STANDARD Postoperative Regimen n=28 Participants Once out of the PACU patients will receive "Standard" postoperative regimen, which includes: 1. Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain 2. Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain 3. Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain 4. Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain. 5. Patients will be discharged home with Motrin and Percocet for pain PRN.
Length of Stay	1 nights Interval 1.0 to 1.0	1 nights Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: VAS Scores at 4 days post-surgery.

Population: 66 participants were enrolled (36 ICE-T arm; 30 Standard Care arm). The final analysis for postoperative day 4 outcomes included 52 subjects (n=29 ICE-T arm POD4 analysis, 1 withdrew, 6 loss to follow up; n=23 Standard arm POD4 analysis, 7 loss to follow up).

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)

Outcome measures

Outcome measures
Measure	"ICE-T" Opioid Sparing Regimen n=29 Participants 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 patient's requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control	STANDARD Postoperative Regimen n=23 Participants Once out of the PACU patients will receive "Standard" postoperative regimen, which includes: 1. Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain 2. Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain 3. Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain 4. Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain. 5. Patients will be discharged home with Motrin and Percocet for pain PRN.
POD4 VAS Scores	3 Score on a scale Interval 1.5 to 5.0	4 Score on a scale Interval 2.5 to 5.0

SECONDARY outcome

Timeframe: Postoperative Day 4

Outcome measures

Outcome measures
Measure	"ICE-T" Opioid Sparing Regimen n=29 Participants 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 patient's requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control	STANDARD Postoperative Regimen n=23 Participants Once out of the PACU patients will receive "Standard" postoperative regimen, which includes: 1. Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain 2. Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain 3. Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain 4. Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain. 5. Patients will be discharged home with Motrin and Percocet for pain PRN.
POD4 Quality of Recovery	179.5 Score on a scale Interval 164.5 to 190.5	177.0 Score on a scale Interval 168.0 to 190.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	"ICE-T" Opioid Sparing Regimen n=29 Participants 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 patient's requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control	STANDARD Postoperative Regimen n=23 Participants Once out of the PACU patients will receive "Standard" postoperative regimen, which includes: 1. Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain 2. Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain 3. Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain 4. Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain. 5. Patients will be discharged home with Motrin and Percocet for pain PRN.
POD4 Satisfaction Score	10.0 Score on a scale Interval 5.8 to 10.0	8.0 Score on a scale Interval 6.0 to 10.0

SECONDARY outcome

Timeframe: Up to post op day 4

Population: Patients that have undergone procedure were observed to see when they had their first bowel movement post-operation up to 4 days. 66 participants were enrolled (36 ICE-T arm; 30 Standard Care arm). The final analysis for postoperative day 4 outcomes included 52 subjects (n=29 ICE-T arm POD4 analysis, 1 withdrew, 6 loss to follow up; n=23 Standard arm POD4 analysis, 7 loss to follow up).

Time to first bowel movement in days

Outcome measures

Outcome measures
Measure	"ICE-T" Opioid Sparing Regimen n=29 Participants 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 patient's requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control	STANDARD Postoperative Regimen n=23 Participants Once out of the PACU patients will receive "Standard" postoperative regimen, which includes: 1. Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain 2. Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain 3. Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain 4. Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain. 5. Patients will be discharged home with Motrin and Percocet for pain PRN.
Time to First Bowel Movement	2 days Interval 1.0 to 3.0	3 days Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	"ICE-T" Opioid Sparing Regimen n=29 Participants 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 patient's requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control	STANDARD Postoperative Regimen n=23 Participants Once out of the PACU patients will receive "Standard" postoperative regimen, which includes: 1. Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain 2. Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain 3. Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain 4. Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain. 5. Patients will be discharged home with Motrin and Percocet for pain PRN.
Oxycodone 5mg Doses Taken Since Discharge	0 Doses Interval 0.0 to 1.0	7.0 Doses Interval 3.0 to 12.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	"ICE-T" Opioid Sparing Regimen n=29 Participants 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 patient's requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control	STANDARD Postoperative Regimen Once out of the PACU patients will receive "Standard" postoperative regimen, which includes: 1. Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain 2. Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain 3. Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain 4. Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain. 5. Patients will be discharged home with Motrin and Percocet for pain PRN.
"ICE-T" Arm Patients Who Requested Supplemental Narcotics in Addition to Their ICE-T Regimen	8 Participants	—

Adverse Events

"ICE-T" Opioid Sparing Regimen

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

STANDARD Postoperative Regimen

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	"ICE-T" Opioid Sparing Regimen n=36 participants at risk 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	STANDARD Postoperative Regimen n=30 participants at risk Once out of the PACU patients will receive "Standard" postoperative regimen, which includes: 1. Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain 2. Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain 3. Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain 4. Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain. 5. Patients will be discharged home with Motrin and Percocet for pain PRN.
Injury, poisoning and procedural complications Intraoperative Complication: Cystotomy	8.3% 3/36 • Number of events 3 • Follow up was until postoperative day 4 (POD 4) Adverse event data was collected from the time of operation up to postoperative day 4. This was systematically collected via chart review, as well as a questionnaire administered to patients via phone in order to capture any events treated outside the study institution.	3.3% 1/30 • Number of events 1 • Follow up was until postoperative day 4 (POD 4) Adverse event data was collected from the time of operation up to postoperative day 4. This was systematically collected via chart review, as well as a questionnaire administered to patients via phone in order to capture any events treated outside the study institution.
Gastrointestinal disorders Emergency Room Visit Post-Operatively - Constipation	0.00% 0/36 • Follow up was until postoperative day 4 (POD 4) Adverse event data was collected from the time of operation up to postoperative day 4. This was systematically collected via chart review, as well as a questionnaire administered to patients via phone in order to capture any events treated outside the study institution.	3.3% 1/30 • Number of events 1 • Follow up was until postoperative day 4 (POD 4) Adverse event data was collected from the time of operation up to postoperative day 4. This was systematically collected via chart review, as well as a questionnaire administered to patients via phone in order to capture any events treated outside the study institution.
Injury, poisoning and procedural complications Emergency Room Visit Post-operatively - Pain	2.8% 1/36 • Number of events 1 • Follow up was until postoperative day 4 (POD 4) Adverse event data was collected from the time of operation up to postoperative day 4. This was systematically collected via chart review, as well as a questionnaire administered to patients via phone in order to capture any events treated outside the study institution.	3.3% 1/30 • Number of events 1 • Follow up was until postoperative day 4 (POD 4) Adverse event data was collected from the time of operation up to postoperative day 4. This was systematically collected via chart review, as well as a questionnaire administered to patients via phone in order to capture any events treated outside the study institution.
Injury, poisoning and procedural complications Emergency Room Visit - Intraoperative complication	5.6% 2/36 • Number of events 2 • Follow up was until postoperative day 4 (POD 4) Adverse event data was collected from the time of operation up to postoperative day 4. This was systematically collected via chart review, as well as a questionnaire administered to patients via phone in order to capture any events treated outside the study institution.	0.00% 0/30 • Follow up was until postoperative day 4 (POD 4) Adverse event data was collected from the time of operation up to postoperative day 4. This was systematically collected via chart review, as well as a questionnaire administered to patients via phone in order to capture any events treated outside the study institution.
Injury, poisoning and procedural complications Intraoperative complication: bowel repair	2.8% 1/36 • Number of events 1 • Follow up was until postoperative day 4 (POD 4) Adverse event data was collected from the time of operation up to postoperative day 4. This was systematically collected via chart review, as well as a questionnaire administered to patients via phone in order to capture any events treated outside the study institution.	0.00% 0/30 • Follow up was until postoperative day 4 (POD 4) Adverse event data was collected from the time of operation up to postoperative day 4. This was systematically collected via chart review, as well as a questionnaire administered to patients via phone in order to capture any events treated outside the study institution.

Additional Information

Dr. Robert Pollard

Metrohealth System

Phone: 2167781446

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place