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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "ICE-T" | Experimental | 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
|
|
| Standard of Care (Control) | Active Comparator | Regimen #2 STANDARD Postoperative Regimen
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | Use of non-steroidal anti-inflammatory drug for pain control postoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| POD1 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) |
| Measure | Description | Time Frame |
|---|---|---|
| POD1 Quality of Recovery Score | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| "ICE-T" Arm Patients Who Requested Supplemental Narcotics in Addition to Their ICE-T Regimen | 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. |
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Pollard, MD | MetroHealth Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
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| Label | URL |
|---|---|
| Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial | View source |
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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.
Prior to surgery, patients will be asked to participate in the study in their private patient rooms or in medical clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | "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
|
| FG001 | STANDARD Postoperative Regimen | Once out of the PACU patients will receive "Standard" postoperative regimen, which includes:
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
66 participants were enrolled at baseline (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).
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| ID | Title | Description |
|---|---|---|
| BG000 | ICE-T | Toradol and Tylenol were given as pain management post-operative of total laparoscopic hysterectomy |
| BG001 | Standard of Care (Control) | Received routine pain management postoperative of laparoscopic hysterectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | POD1 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) | 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). | Posted | Median | Inter-Quartile Range | Score on a scale | Morning of post operative day 1 (~24 hours after surgery) |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | "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
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraoperative Complication: Cystotomy | Injury, poisoning and procedural complications | Systematic Assessment | An injury to the bladder during the surgery. The occurrences of these injuries happened prior to the patients randomization in the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Pollard | Metrohealth System | 2167781446 | rpollard@metrohealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 4, 2021 | Oct 25, 2023 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 18, 2019 | Jun 15, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| D000701 | Analgesics, Opioid |
| D010098 | Oxycodone |
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| D004091 | Hydromorphone |
| C514822 | oxycodone-acetaminophen |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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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.
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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.
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| Opioids | Drug | Use of narcotic for pain control postoperatively |
|
|
| Ice Packs | Other | Placement of Ice packs on surgical sites postoperatively |
|
| Tylenol | Drug | Use of pain medication postoperatively |
|
|
| Motrin | Drug | Use of non-steroidal anti-inflammatory drug for pain control postoperatively |
|
|
| Dilaudid Injectable Product | Drug | Use of narcotic for pain control postoperatively |
|
|
| Percocet 5Mg-325Mg Tablet | Drug | Use of combination tablet of Tylenol and Oxycodone for pain control postoperatively |
|
|
| Postoperative Day 1 |
| 1st 24hr Total Dose of Narcotic | 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. | Total narcotic use from intra-op to 24 hours post-op |
| Length of Stay | 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. | Post-operative Day 1 |
| POD4 VAS Scores | 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) | VAS Scores at 4 days post-surgery. |
| POD4 Quality of Recovery | 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. | Postoperative Day 4 |
| POD4 Satisfaction Score | 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. | Data collected as of postoperative day 4 |
| Time to First Bowel Movement | Time to first bowel movement in days | Up to post op day 4 |
| Oxycodone 5mg Doses Taken Since Discharge | The number of oxycodone 5mg doses (whether as oxycodone 5mg or as percocet 5/325) taken since discharge up until postoperative 4. | Data collected as of Postoperative day 4 |
| Up until postoperative day 4 |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | 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). | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 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). | Count of Participants | Participants |
|
| Race (NIH/OMB) | 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). | Count of Participants | Participants |
|
| Body Mass Index | 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). | Median | Inter-Quartile Range | kg/m^2 |
|
| Depression/Anxiety | 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). | Count of Participants | Participants |
|
| Current Smoker | 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). | Count of Participants | Participants |
|
| Charlson Comorbidity Index | The Charleston Comorbidity Index calculates the 10-year survival of a patient. It considers age, history of: myocardial infarction, congestive heart failure, peripheral vascular disease, stroke, dementia, chronic obstructive pulmonary disease, connective tissue disease, peptic ulcer disease, liver disease, diabetes mellitus, hemiplegia, chronic kidney disease, solid cancers, leukemia, lymphoma, and AIDS. As this value ranges from 0-37, with highest value of 37 representing 0% survival in 10 years, and lowest value of 0 at 98% survival in 10 years, it is possible for median/mean to be zero. | 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). | Median | Inter-Quartile Range | Index |
|
| STOP-BANG Score | The STOP-BANG Score is questionnaire that screens for obstructive sleep apnea. It is an acronym for Snoring, Tiredness, Observed apnea, Pressure (high blood pressure), Body Mass Index, Age greater than 50 years, Neck circumference greater than 40 cm, Gender male (male gender gives an additional score). The score ranges from 0 - 8, with 8 being the highest risk for moderate to severe apnea. Patients are considered to be considered high risk for sleep apnea when their summed score is greater than or equal to 3. | 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). | Median | Inter-Quartile Range | scores on a scale |
|
| OG001 | STANDARD Postoperative Regimen | Once out of the PACU patients will receive "Standard" postoperative regimen, which includes:
|
|
|
|
| Secondary | POD1 Quality of Recovery Score | 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. | 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). | Posted | Median | Inter-Quartile Range | Score on a scale | Postoperative Day 1 |
|
|
|
|
| Secondary | 1st 24hr Total Dose of Narcotic | 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. | 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. | Posted | Median | Inter-Quartile Range | oral morphine milligram equivalents | Total narcotic use from intra-op to 24 hours post-op |
|
|
|
|
| Secondary | Length of Stay | 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. | 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). | Posted | Median | Inter-Quartile Range | nights | Post-operative Day 1 |
|
|
|
|
| Secondary | POD4 VAS Scores | 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) | 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). | Posted | Median | Inter-Quartile Range | Score on a scale | VAS Scores at 4 days post-surgery. |
|
|
|
|
| Secondary | POD4 Quality of Recovery | 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. | 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). | Posted | Median | Inter-Quartile Range | Score on a scale | Postoperative Day 4 |
|
|
|
|
| Secondary | POD4 Satisfaction Score | 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. | 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). | Posted | Median | Inter-Quartile Range | Score on a scale | Data collected as of postoperative day 4 |
|
|
|
|
| Secondary | Time to First Bowel Movement | Time to first bowel movement in days | 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). | Posted | Median | Inter-Quartile Range | days | Up to post op day 4 |
|
|
|
|
| Secondary | Oxycodone 5mg Doses Taken Since Discharge | The number of oxycodone 5mg doses (whether as oxycodone 5mg or as percocet 5/325) taken since discharge up until postoperative 4. | 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). | Posted | Median | Inter-Quartile Range | Doses | Data collected as of Postoperative day 4 |
|
|
|
|
| Other Pre-specified | "ICE-T" Arm Patients Who Requested Supplemental Narcotics in Addition to Their ICE-T Regimen | 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. | 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). | Posted | Count of Participants | Participants | Up until postoperative day 4 |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 7 |
| 36 |
| EG001 | STANDARD Postoperative Regimen | Once out of the PACU patients will receive "Standard" postoperative regimen, which includes:
| 0 | 30 | 0 | 30 | 3 | 30 |
|
| Emergency Room Visit Post-Operatively - Constipation | Gastrointestinal disorders | Systematic Assessment | Postoperative constipation requiring an emergency room visit |
|
| Emergency Room Visit Post-operatively - Pain | Injury, poisoning and procedural complications | Systematic Assessment | Uncontrolled postoperative pain requiring an emergency room visit |
|
| Emergency Room Visit - Intraoperative complication | Injury, poisoning and procedural complications | Systematic Assessment | Emergency room visit for urgent follow up on an intraoperative complication |
|
| Intraoperative complication: bowel repair | Injury, poisoning and procedural complications | Systematic Assessment | An injury to the bowel during the surgery that required repair. The occurrence of this injury happened prior to the patients randomization in the study. |
|
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| D006571 | Heterocyclic Compounds |
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |