Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2021-08-11
2023-03-26
Brief Summary
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Detailed Description
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Prospective, observational study with institutional review board (IRB) approval. Women who undergo elective cesarean delivery under neuraxial block receive neuraxial opioids for postoperative analgesia.
Potential study recruits will be approached prior to the cesarean delivery anesthesia assessment. Suitable women will be informed that neuraxial morphine is the gold-standard analgesia, however many women suffer nausea, vomiting and pruritus (itching) and may prefer an alternative analgesic or a lower dose of morphine. All women will receive intrathecal fentanyl as an adjuvant to the bupivacaine anesthesia. This fentanyl may also cause pruritus however this is limited to the 2-hour duration of the effect of the fentanyl.
Women will be offered standard neuraxial anesthesia for cesarean delivery (heavy bupivacaine 10 mg; fentanyl 10-25mic; and low dose intrathecal morphine mic). Alternatively, women will be offered an alternative anesthesia option: 1) heavy bupivacaine 10 mg; fentanyl 10-15 mic with an ultra-low dose, 50 mic of morphine, or 2) heavy bupivacaine 10 mg; fentanyl 10-25 mic without intrathecal morphine + postoperative bilateral quadratus lumborum block (QLB), transversus abdominis plane (TAP) or erector spinus block (ESP). For patients who select block without intrathecal morphine, the choice of block will depend on anesthesiologist's decision.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Standard neuraxial opioids
Standard neuraxial anesthesia for cesarean delivery (heavy bupivacaine 10 mg; fentanyl 10-25 mic; and low dose intrathecal morphine
Respiratory Monitor
All women receive a respiratory rate monitor after cesarean delivery. We anticipate that at least 30 women will receive standard dose neuraxial block, and aim to have a cohort of 20-30 women who receive non-standard dose (Group 20 in order to compare respiratory rates.
Non standard neuraxial opioids
Non standard low-dose morphine group (with heavy bupivacaine 10 mg; fentanyl 10-25 mic)
Women are offered - if they prefer not to receive low dose morphine, the option of either ultra-low dose morphine or no morphine - instead they can receive postoperative bilateral quadratus lumborum block (QLB), TAP or erector spinus block.
Respiratory Monitor
All women receive a respiratory rate monitor after cesarean delivery. We anticipate that at least 30 women will receive standard dose neuraxial block, and aim to have a cohort of 20-30 women who receive non-standard dose (Group 20 in order to compare respiratory rates.
Interventions
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Respiratory Monitor
All women receive a respiratory rate monitor after cesarean delivery. We anticipate that at least 30 women will receive standard dose neuraxial block, and aim to have a cohort of 20-30 women who receive non-standard dose (Group 20 in order to compare respiratory rates.
Eligibility Criteria
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Inclusion Criteria
* age between 18 and 50
* gestational age greater than 37 completed weeks
* singleton pregnancy. In contrast to previous studies
* we do not plan to exclude obese women and those with suspected sleep apnea.
Exclusion Criteria
* narcotic administration in the previous 2 hours
* inability to adequately understand the consent form
* moderate-severe asthma, inability to receive morphine
* sensitivity to sticker
* skin conditions.
18 Years
55 Years
FEMALE
No
Sponsors
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Stanford University
OTHER
Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Locations
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Tel AViv Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Other Identifiers
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TASMC-2020-CFW-608-19-CTIL
Identifier Type: -
Identifier Source: org_study_id
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