Opioid Substitution TreatmentPhase 4NCT03987022
ICE-T Pain Regimen for Total Laparoscopic Hysterectomy
A Phase 4 study testing Ketorolac, Opioids and Ice Packs in people with Opioid Substitution Treatment, run by MetroHealth Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Opioid Substitution Treatment
- What is being tested?
- Ketorolac, Opioids and Ice Packs
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 25 Apr 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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
Who cannot join
- History of chronic pelvic pain
- Abdominal surgery
- History of psychiatric disease
- Currently taking analgesic medications
- Currently taking sedatives
- Liver disease
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "ICE-T" Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Laparoscopic Gynecologic Surgery: a Randomized Controlled Trial
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.
Read the detailed description
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
- Opioid Substitution Treatment
- Being tested
- Ketorolac, Opioids, Ice Packs, Tylenol, Motrin
- Keywords
- Anti-inflammatory agents non-steroidal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Also called Toradol
Use of non-steroidal anti-inflammatory drug for pain control postoperatively
OpioidsDrug
Also called Oxycodone
Use of narcotic for pain control postoperatively
Ice PacksOther
Placement of Ice packs on surgical sites postoperatively
TylenolDrug
Also called Acetaminophen
Use of pain medication postoperatively
MotrinDrug
Also called Ibuprofen
Use of non-steroidal anti-inflammatory drug for pain control postoperatively
Dilaudid Injectable ProductDrug
Also called Hydromorphone
Use of narcotic for pain control postoperatively
Percocet 5Mg-325Mg TabletDrug
Also called Oxycodone-Acetaminophen
Use of combination tablet of Tylenol and Oxycodone for pain control postoperatively
| Study group | Role | What they receive |
|---|---|---|
| "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
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 Receives: Drug: Ketorolac; Drug: Opioids; Other: Ice Packs; Drug: Tylenol; Drug: Dilaudid Injectable Product |
| Standard of Care (Control) | Active comparator | 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. Receives: Drug: Opioids; Drug: Motrin; Drug: Dilaudid Injectable Product; Drug: Percocet 5Mg-325Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Morning of post operative day 1 (~24 hours after surgery)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Data collected as of postoperative day 4
Time to First Bowel Movement
Time to first bowel movement in days
Measured: 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.
Measured: Data collected as of Postoperative day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start1 Aug 2019
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid Substitution TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Pollard, MD, MetroHealth Medical Center
- Investigators
- Robert Pollard, MD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987022
- Sponsor's protocol ID
- IRB18-00920
- Status last verified
- Jan 2025
- First submitted
- 11 Jun 2019
- Last updated
- 24 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "ICE-T" Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Laparoscopic Gynecologic Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03987022
- Acronym / sponsor ID
- IRB18-00920
- Conditions
- Opioid Substitution Treatment
- Keywords
- Anti-inflammatory agents non-steroidal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Posted 24 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| "ICE-T" | Experimental | Drug: Ketorolac, Drug: Opioids, Other: Ice Packs, Drug: Tylenol, Drug: Dilaudid Injectable ProductRegimen #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 |
| Standard of Care (Control) | Active comparator | Drug: Opioids, Drug: Motrin, Drug: Dilaudid Injectable Product, Drug: Percocet 5Mg-325Mg TabletRegimen #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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (19 listed)
- History of chronic pelvic pain
- Abdominal surgery
- History of psychiatric disease
- Currently taking analgesic medications
- Currently taking sedatives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetorolacAlso: ToradolUse of non-steroidal anti-inflammatory drug for pain control postoperatively | Drug | "ICE-T" |
| OpioidsAlso: OxycodoneUse of narcotic for pain control postoperatively | Drug | "ICE-T", Standard of Care (Control) |
| Ice PacksPlacement of Ice packs on surgical sites postoperatively | Other | "ICE-T" |
| TylenolAlso: AcetaminophenUse of pain medication postoperatively | Drug | "ICE-T" |
| MotrinAlso: IbuprofenUse of non-steroidal anti-inflammatory drug for pain control postoperatively | Drug | Standard of Care (Control) |
| Dilaudid Injectable ProductAlso: HydromorphoneUse of narcotic for pain control postoperatively | Drug | "ICE-T", Standard of Care (Control) |
| Percocet 5Mg-325Mg TabletAlso: Oxycodone-AcetaminophenUse of combination tablet of Tylenol and Oxycodone for pain control postoperatively | Drug | Standard of Care (Control) |
Primary outcome
POD1 Visual Analog Pain (VAS) Score
Time frame: Morning of post operative day 1 (~24 hours after surgery)
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)
8 secondary outcomes
POD1 Quality of Recovery Score
Time frame: Postoperative Day 1
1st 24hr Total Dose of Narcotic
Time frame: Total narcotic use from intra-op to 24 hours post-op
Length of Stay
Time frame: Post-operative Day 1
POD4 VAS Scores
Time frame: VAS Scores at 4 days post-surgery.
POD4 Quality of Recovery
Time frame: Postoperative Day 4
POD4 Satisfaction Score
Time frame: Data collected as of postoperative day 4
Time to First Bowel Movement
Time frame: Up to post op day 4
Oxycodone 5mg Doses Taken Since Discharge
Time frame: Data collected as of Postoperative day 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Pollard, MD principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketorolac, Opioids and Ice Packs in people with Opioid Substitution Treatment, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POD1 Visual Analog Pain (VAS) Score (time frame: Morning of post operative day 1 (~24 hours after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.