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The purpose of this study is to find out whether oral Naloxegol can reduce the side effects of opioid painkillers following surgery. This study aims to explore whether Naloxegol can similarly reduce opioid-induced side effects in post-surgical patients. About 130 surgery patients will participate in this study which is being conducted at Cleveland Clinic Main Campus.
Opioids are the gold standard for postoperative pain management, but they have been shown to produce uncomfortable side effects such as urinary retention (an inability to completely empty the bladder), constipation and nausea/vomiting. Clinical evidence demonstrates that Naloxegol can safely and effectively block these undesirable side effects while maintaining the painkilling effects of opioids in outpatients suffering from opioid-induced constipation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Naloxegol 25 mg given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first |
|
| Placebo Arm | Placebo Comparator | Matching placebo given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naloxegol 25 MG | Drug | Oral Naloxegol 25 MG |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Residual Urine Volume | Residual urine volume in the bladder as assessed by bladder scan | from Postoperative days 1 to POD 2 or until day of discharge whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| Side Effects of Naloxegol on Other Opioid Related Side Effects | Opioid-related Symptom Distress Scale (ORSDS) is a 4 point-scale that evaluates three symptom distress dimensions (frequency, severity, bothersomeness) for opioid-related side effects. The 12 elements of the ORSDS are nausea, vomiting, constipation, difficulty passing urine, difficulty concentrating, drowsiness, lightheaded, fatigue, feeling confused, itchiness, dry mouth, and headache. The ORSDS questionnaire was administered by a trained investigator on first and second postoperative days while patients remained hospitalized. We reported the average ORSDS score from all 12 elements, which ranged from 0 to 4 and higher scores represent worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehmet A Turan, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
Data to be provided in aggregate without patient identifiers
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of 508 patients screened, 136 patients meet all inclusion and exclusion criteria and gave consent to the study. 136 patients were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment-Naloxegol | Naloxegol 25 mg given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first Naloxegol 25 MG: Oral Naloxegol 25 MG |
| FG001 | Placebo Arm | Matching placebo given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first Placebo: matching oral placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment-Naloxegol | Naloxegol 25 mg given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first Naloxegol 25 MG: Oral Naloxegol 25 MG |
| BG001 | Placebo Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Residual Urine Volume | Residual urine volume in the bladder as assessed by bladder scan | 17 patients were completely missing on urine residual. Multiple imputation was used solely for estimating the treatment effect on urinal residual. The summary statistics of urine residual for each day was reported based on original data. | Posted | Median | Inter-Quartile Range | ml | from Postoperative days 1 to POD 2 or until day of discharge whichever occurs first |
|
until discharge from hospital, an average of 2 day, up to 3 days
Adverse events of particular interest are:
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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 | Treatment-Naloxegol | Naloxegol 25 mg given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first Naloxegol 25 MG: Oral Naloxegol 25 MG |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Troponin elevation and ST elevation | Cardiac disorders | Systematic Assessment | Patient was transferred to coronary ICU for further care. A heparin infusion was initiated. A left heart cath is planned for 5/31/2018. Reported to PI. Not related to study medication. Continue to follow patient status. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alparslan Turan, MD | Cleveland Clinic | 216-4459857 | turana@ccf.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 | Nov 26, 2019 | Jul 27, 2023 | Prot_SAP_006.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 23, 2017 | Jul 18, 2017 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C000589308 | naloxegol |
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Effect of Naloxegol on reversing opioid-related side effects in patients recovering from elective primary hip surgery under spinal anesthesia who will be randomly assigned to oral Naloxegol or placebo for two postoperative days or until the date of discharge, whichever occurs earlier. The design will be a randomized, double-blind, placebo-controlled trial of oral Naloxegol in adults having elective primary hip or knee surgery under spinal anesthesia. The study will be performed at the Cleveland Clinic hospitals.
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| Placebo | Drug | matching oral placebo |
|
| Postoperative days 1-2 or until day of discharge whichever occurs first |
| Need for Indwelling Urinary Catheterization | Number of patients receiving Naloxegol requiring indwelling urinary catheters | Postoperative days 1-2 or until day of discharge whichever occurs first |
| Quality of Recovery | Quality of recovery is a validated scoring system that quantifies patients' early postoperative health status with range of 0-150 where higher score means better quality of recovery. We used the 15-question version, the QoR-15 | Postoperative Days 2 or discharge day whichever was earlier |
Matching placebo given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first
Placebo: matching oral placebo
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| ASA status | ASA Physical Status Classification System, where lower number means better condition. I means a normal healthy patient and VI means a declared brain-dead patient whose organs are being removed for donor purposes | Count of Participants | Participants |
|
| Apfel PONV score | Apfel Score for Postoperative Nausea and Vomiting. The EMR- based risk scoring tool was integrated into all preanesthetic assessments and allowed for the assignment of low, moderate, or high risk of PONV. Low risk was defined as an Apfel score of 0 to1, medium risk was defined as an Apfel score of 2, and high risk was defined as an Apfel score of 3 or greater. The minimum of the score is 0 and maximum score is 4. | Median | Inter-Quartile Range | units on a scale |
|
| Chronic opioid use | Chronic opioid use will be defined as opioid use for more than 30 consecutive days, at a daily dose of 15 mg or more of morphine or equivalent, within the 3 months before surgery. | Count of Participants | Participants |
|
| Surgery type | Count of Participants | Participants |
|
| Surgery duration | Median | Inter-Quartile Range | hours |
|
| Medical history | Count of Participants | Participants |
|
| Anesthesia type | one patient was missing on anesthesia type information | Count of Participants | Participants |
|
| Intraoperative colloids, ml | one patient was missing on colloids information | Median | Inter-Quartile Range | ml |
|
| Intraoperative crystalloids | one patient was missing on crystalloids | Median | Inter-Quartile Range | ml |
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| Intraoperative RBC | one patient was missing | Median | Inter-Quartile Range | cc |
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| Intraoperative platelets | one patient was missing | Median | Inter-Quartile Range | cc |
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| intraoperative Urine | one patient was missing | Median | Inter-Quartile Range | cc |
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| Intraoperative opioid use | one patient was missing | Median | Inter-Quartile Range | mg |
|
Matching placebo given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first
Placebo: matching oral placebo
|
|
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| Secondary | Side Effects of Naloxegol on Other Opioid Related Side Effects | Opioid-related Symptom Distress Scale (ORSDS) is a 4 point-scale that evaluates three symptom distress dimensions (frequency, severity, bothersomeness) for opioid-related side effects. The 12 elements of the ORSDS are nausea, vomiting, constipation, difficulty passing urine, difficulty concentrating, drowsiness, lightheaded, fatigue, feeling confused, itchiness, dry mouth, and headache. The ORSDS questionnaire was administered by a trained investigator on first and second postoperative days while patients remained hospitalized. We reported the average ORSDS score from all 12 elements, which ranged from 0 to 4 and higher scores represent worse outcome. | some patients were missing on this outcome at repeated measurements. A mixed effects model assuming auto-regressive correlation structure and the outcome was log-transformed | Posted | Median | Inter-Quartile Range | log(score on a scale) | Postoperative days 1-2 or until day of discharge whichever occurs first |
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| Secondary | Need for Indwelling Urinary Catheterization | Number of patients receiving Naloxegol requiring indwelling urinary catheters | Our final analyzed study population had 131 patients since 5 patients did not complete (due to withdrawal or not receiving any treatment) the study thus were removed from the final analysis. Among 131 patients, 4 patients were missing from this analysis. | Posted | Count of Participants | Participants | Postoperative days 1-2 or until day of discharge whichever occurs first |
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| Secondary | Quality of Recovery | Quality of recovery is a validated scoring system that quantifies patients' early postoperative health status with range of 0-150 where higher score means better quality of recovery. We used the 15-question version, the QoR-15 | We only had a total of 131 patients in our final analysis since 5 patients were removed from the final analysis due to not completing the study (withdrawal or not receiving any treatment). Among 131 patients, 9 patients were missing from this analysis | Posted | Median | Inter-Quartile Range | units on a scale | Postoperative Days 2 or discharge day whichever was earlier |
|
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| 0 |
| 67 |
| 1 |
| 67 |
| 0 |
| 67 |
| EG001 | Placebo Arm | Matching placebo given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first Placebo: matching oral placebo | 0 | 64 | 0 | 64 | 0 | 64 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| 3 |
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| 4 |
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| Day 2 |
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