ICE-T Pain Regimen for Total Laparoscopic Hysterectomy

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)

Time frame: 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).

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.

Time frame: 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.

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.

Time frame: Post-operative 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).

The number of oxycodone 5mg doses (whether as oxycodone 5mg or as percocet 5/325) taken since discharge up until postoperative 4.

Time frame: Data collected as of Postoperative day 4

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).

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.

Time frame: 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.

Time frame: Postoperative Day 4

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).

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.

Time frame: Data collected as of postoperative day 4

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)

Time frame: 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).

Time to first bowel movement in days

Time frame: 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).

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.

Time frame: Up until postoperative day 4

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).