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The use of intrathecal opioids for analgesia in the setting of cesarean section has become standard obstetric anesthesia practice. Currently, two opioids are commonly used. These opioids are fentanyl and morphine (Duramorph). Intrathecal opioids are an excellent source of analgesia and act to reduce the stress response to surgery.
Currently, most obstetric anesthesiologists use intrathecal morphine for analgesia after cesarean delivery. Morphine provides excellent analgesia for cesarean section. However, use of this medication is associated with side effects such as pruritus and nausea and vomiting.
Recently, multiple obstetric anesthesia groups began to use intrathecal hydromorphone for cesarean delivery when morphine was unavailable. As groups began to use hydromorphone, retrospective data became available that demonstrated its safety and efficacy for use during cesarean section.
In order to fully elucidate the analgesic and side effect properties of hydromorphone for cesarean delivery, a prospective randomized, double blind study comparing morphine and hydromorphone is necessary. The investigators need to understand whether hydromorphone is as effective as morphine for analgesia after cesarean section, and whether it is associated with fewer or more side effects. The results of the study will allow providers to make educated decisions to better care for their patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrathecal morphine | Active Comparator | 0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections |
|
| Intrathecal hydromorphone | Experimental | 50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrathecal morphine | Drug | 0.25mg intrathecal morphine is the standard opioid medication the investigators use for analgesia for cesarean sections. It is the control arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Fentanyl PCA Consumption | Total dose of fentanyl patient controlled analgesia (pca) used in 24 hours post-op. | at 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Initial PCA Use | When does the patient need to use the PCA for the first time? This will be used to assess when morphine and hydromorphone first begin to provide analgesia. | up to 24 hours |
| Pain Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yaakov Beilin, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
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Recruitment began in April 2014 with enrollment from May 2014 to May 2017
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| ID | Title | Description |
|---|---|---|
| FG000 | Intrathecal Morphine | 0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections Intrathecal morphine: 0.25mg intrathecal morphine is the standard opioid medication the investigators use for analgesia for cesarean sections. It is the control arm. |
| FG001 | Intrathecal Hydromorphone | 50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections. Intrathecal hydromorphone: 50mcg intrathecal hydromorphone will be added to 1.5mg 0.75% bupivicaine for single shot spinal anesthesia. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intrathecal Morphine | 0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections |
| BG001 | Intrathecal Hydromorphone |
| 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 | Post Operative Fentanyl PCA Consumption | Total dose of fentanyl patient controlled analgesia (pca) used in 24 hours post-op. | Posted | Mean | Standard Deviation | µg | at 24 hours |
|
up to 24 hours
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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 | Intrathecal Morphine | 0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yaakov Beilin | Icahn School of Medicine at Mount Sinai | 212-241-7467 | yaakov.beilin@mountsinai.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 | Jul 20, 2012 | Jul 11, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
| Intrathecal hydromorphone | Drug | 50mcg intrathecal hydromorphone will be added to 1.5mg 0.75% bupivicaine for single shot spinal anesthesia. |
|
|
Assess pain scores on a scale of 1-5, with higher score indicating more pain.
| at 24 hours |
| Patient Satisfaction Score | Patient satisfaction score - total scale of 1-5, with higher score indicating more satisfaction | at 24 hours |
| Symptom Scale for Two Specific Side Effects of Nausea and Pruritus | Symptom scale for nausea and pruritus. Full scale from 1-5, with higher score indicating more symptoms. | up to 24 hours |
50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Time to Initial PCA Use | When does the patient need to use the PCA for the first time? This will be used to assess when morphine and hydromorphone first begin to provide analgesia. | data not collected. | Posted | up to 24 hours |
|
|
| Secondary | Pain Score | Assess pain scores on a scale of 1-5, with higher score indicating more pain. | Posted | Mean | Full Range | score on a scale | at 24 hours |
|
|
|
| Secondary | Patient Satisfaction Score | Patient satisfaction score - total scale of 1-5, with higher score indicating more satisfaction | Posted | Mean | Full Range | score on a scale | at 24 hours |
|
|
|
| Secondary | Symptom Scale for Two Specific Side Effects of Nausea and Pruritus | Symptom scale for nausea and pruritus. Full scale from 1-5, with higher score indicating more symptoms. | Posted | Mean | Full Range | score on a scale | up to 24 hours |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 36 |
| 40 |
| EG001 | Intrathecal Hydromorphone | 50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections. | 0 | 40 | 0 | 40 | 35 | 40 |
| Puritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |