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Epidurals are an effective means for providing neuraxial anesthesia and analgesia. Prior studies in labor epidurals have demonstrated that a programmed intermittent bolus application of local anesthesia can improve pain control by reducing the amount of local anesthetic required as well as improve patient satisfaction when compared to continuous epidural infusions. The effects of programmed intermittent bolus of epidural local anesthetics compared to continuous epidural infusions in a surgical setting have yet to be elucidated. Our goal is to evaluate the use of programmed intermittent bolus compared to continuous epidural infusion in a surgical patient population. We plan to enroll patients already undergoing abdominal surgeries including colorectal, gynecologic, surgical oncology, urological where epidural anesthesia can be employed. The primary endpoints of the study will be the total local anesthetic consumption and total opioid consumption as surrogate markers for the quality of epidural anesthesia. Secondary endpoints are pain scores and functional measurements, patient satisfaction, and incidence of hypotension.
See brief summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous epidural infusion | Active Comparator | At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows: Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump. Additional oral and intravenous analgesia medications are available as scheduled and pro re nata. |
|
| Programmed intermittent epidural bolus | Experimental | For the programmed intermittent epidural bolus group: Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump. Additional oral and intravenous analgesia medications are available as scheduled and pro re nata. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Local Anesthetic Utilized in First 24 Hours | Total local anesthetic consumed while epidural in place, recorded on infusion pump | In first 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumed | Total opioid consumed (intravenous or po) while epidural in place | While epidural in place (up to 72 hours post operatively) |
| Patient Satisfaction Score | Ranked patient satisfaction scores while epidural in place. Measured by modified pain inventory. Minimum is 0, maximum of 10. 10 indicates highest patient satisfaction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Behrends, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94158 | United States |
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Patients were not randomized to study groups if epidurals were not able to be successfully placed.
2 subjects in the CEI group were no included in the analysis due to missing data
1 subject in the PIEB group was not included in the analysis due to missing data
Patients were enrolled between December 2016 to December 2018
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Epidural Infusion | At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows: Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump. Additional oral and intravenous analgesia medications are available as scheduled and pro re nata. Bupivacaine Fentanyl |
| FG001 | Programmed Intermittent Epidural Bolus | For the programmed intermittent epidural bolus group: Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump. Additional oral and intravenous analgesia medications are available as scheduled and pro re nata. Bupivacaine Fentanyl |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Epidural Infusion | At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows: Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump. Additional oral and intravenous analgesia medications are available as scheduled and pro re nata. Bupivacaine Fentanyl |
| 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 | Total Local Anesthetic Utilized in First 24 Hours | Total local anesthetic consumed while epidural in place, recorded on infusion pump | Note that 2 patients in the CEI group and 1 patient in the PIEB group was not included in the analysis due to missing data. | Posted | Median | Inter-Quartile Range | mg | In first 24 hours |
|
Data collected from day of surgery until removal of epidural, on average epidurals were removed between day 1 and 3. Rare clinical scenarios, epidurals can remain as long as 7 days
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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 | Continuous Epidural Infusion | At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows: Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump. Additional oral and intravenous analgesia medications are available as scheduled and pro re nata. Bupivacaine Fentanyl |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Non-systematic Assessment | mean arterial blood pressure less than 60 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Su | University of California San Francisco | 415-885-7246 | paul.su@Ucsf.edu |
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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 | Jul 30, 2018 | Apr 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Fentanyl | Drug |
|
|
| While epidural in place (up to 72 hours postoperatively) |
| Average Pain Severity | Measured by modified pain inventory on a daily basis while epidural in place. Minimum is 0, maximum is 10. 10 indicates highest pain severity. | While epidural in place (up to 72 hours postoperatively) |
| Incidence of Hypotension | Most common side effect post-operatively with epidural anesthesia. Documented by recorded vitals signs, fluid resuscitation, and temporary cessation of epidural medication. | While epidural in place (24 hours postoperatively) |
| Worst Reported 24 Hour Pain | Minimum is 0, maximum is 10. 10 indicates highest pain severity. | While epidural in place (up to 72 hours postoperatively) |
| Average Pain Interference | Minimum is 0, maximum is 10. 10 indicates highest pain interference. | While epidural in place (up to 72 hours postoperatively) |
| Hypotension |
|
| Nonfunctional epidural |
|
| Planned epidural removal |
|
| Intrathecal catheter placement |
|
| BG001 | Programmed Intermittent Epidural Bolus | For the programmed intermittent epidural bolus group: Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump. Additional oral and intravenous analgesia medications are available as scheduled and pro re nata. Bupivacaine Fentanyl |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Home Medication Use | Count of Participants | Participants |
|
| Daily opioid consumption | Median | Inter-Quartile Range | MME |
|
| Pain Severity | Minimum of 0, maximum of 10. 10 indicates higher severity of pain. | Median | Inter-Quartile Range | units on a scale |
|
| Average Pain Interference | Minimum of 0, maximum of 10. 10 indicates more severe interference of activities due to pain. | Median | Inter-Quartile Range | units on a scale |
|
| World Health Organization Disability Assessment Schedule 2.0 | Minimum of 0, maximum of 100. Score of 100 indicates fully disabled | Mean | Inter-Quartile Range | units on a scale |
|
| HADS Anxiety Score | Count of Participants | Participants |
|
| Depression HADS Score | Count of Participants | Participants |
|
| Length of Epidural Therapy | Median | Inter-Quartile Range | Days |
|
| Type of Surgery | Count of Participants | Participants |
|
| Intraoperative Opioids | Median | Inter-Quartile Range | MME |
|
| OG001 | Programmed Intermittent Epidural Bolus | For the programmed intermittent epidural bolus group: Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump. Additional oral and intravenous analgesia medications are available as scheduled and pro re nata. Bupivacaine Fentanyl |
|
|
|
| Secondary | Total Opioid Consumed | Total opioid consumed (intravenous or po) while epidural in place | Posted | Median | Inter-Quartile Range | MME | While epidural in place (up to 72 hours post operatively) |
|
|
|
| Secondary | Patient Satisfaction Score | Ranked patient satisfaction scores while epidural in place. Measured by modified pain inventory. Minimum is 0, maximum of 10. 10 indicates highest patient satisfaction. | Posted | Median | Inter-Quartile Range | score on a scale | While epidural in place (up to 72 hours postoperatively) |
|
|
|
| Secondary | Average Pain Severity | Measured by modified pain inventory on a daily basis while epidural in place. Minimum is 0, maximum is 10. 10 indicates highest pain severity. | Posted | Median | Inter-Quartile Range | units on a scale | While epidural in place (up to 72 hours postoperatively) |
|
|
|
| Secondary | Incidence of Hypotension | Most common side effect post-operatively with epidural anesthesia. Documented by recorded vitals signs, fluid resuscitation, and temporary cessation of epidural medication. | Posted | Count of Participants | Participants | While epidural in place (24 hours postoperatively) |
|
|
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| Secondary | Worst Reported 24 Hour Pain | Minimum is 0, maximum is 10. 10 indicates highest pain severity. | Posted | Median | Inter-Quartile Range | score on a scale | While epidural in place (up to 72 hours postoperatively) |
|
|
|
| Secondary | Average Pain Interference | Minimum is 0, maximum is 10. 10 indicates highest pain interference. | Posted | Median | Inter-Quartile Range | score on a scale | While epidural in place (up to 72 hours postoperatively) |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 9 |
| 44 |
| EG001 | Programmed Intermittent Epidural Bolus | For the programmed intermittent epidural bolus group: Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump. Additional oral and intravenous analgesia medications are available as scheduled and pro re nata. Bupivacaine Fentanyl | 0 | 52 | 0 | 52 | 18 | 52 |
|
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| D000588 |
| Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 48 - 72 hrs postoperatively |
|
| 48 - 72 hours postoperatively |
|
| 48 - 72 hours postoperatively |
|
| 48 - 72 hours postoperativley |
|
| 48 - 72 hours postoperatively |
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