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Observational Study of Postoperative Respiratory Rate After Cesarean Delivery Among a Convenience Sample of Women Undergoing Spinal Anesthesia With and Without Neuraxial Opioids

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ClinicalTrials.gov Identifier: NCT04250233
Recruitment Status : Not yet recruiting
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief Summary:
The study proposal summarizes aspects related to respiratory rate in women who undergo spinal anesthesia for cesarean delivery who receive or do not receive neuraxial opioids

Condition or disease Intervention/treatment
Cesarean Delivery; Neuraxial Opioids Device: Respiratory Monitor

Detailed Description:

In the current proposal we wish to utilize a respiratory monitoring device to count respiratory rate continuously, as opposed to the intermittent nursing RR counts once per hour. Using this device, we may capture changes in respiratory rate that are not noticed by the nurse during the once per hour count. The device counts respiration (respiratory rate) using a sticker placed by on the neck to detect vibrations made by respiration. This overcomes the specific limitation of capnography that requires wearing the nasal cannula.

Prospective, observational study with 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 20 mic; and low dose intrathecal morphine mic). Alternatively, women will be offered an alternative anesthesia option: 1) heavy bupivacaine 10 mg; fentanyl 20 mic with an ultra-low dose, 50 mic of morphine, or 2) heavy bupivacaine 10 mg; fentanyl 20 mic without intrathecal morphine + postoperative bilateral quadratus lumborum block (QLB) or erector spinus block (ESP). The choice of block will depend on the patient and anesthesiologist's decision.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study of Postoperative Respiratory Rate After Cesarean Delivery Among a Convenience Sample of Women Undergoing Spinal Anesthesia With and Without Neuraxial Opioids
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Group/Cohort Intervention/treatment
Standard neuraxial opioids
Standard neuraxial anesthesia for cesarean delivery (heavy bupivacaine 10 mg; fentanyl 20 mic; and low dose intrathecal morphine
Device: 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 20 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) or erector spinus block.

Device: 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.




Primary Outcome Measures :
  1. Respiratory rate ≤8 [ Time Frame: 24 hours ]
    Our primary study aim is to report the number of women with RR≤8 at any time point after the cesarean delivery using the continuous respiratory monitoring device.


Secondary Outcome Measures :
  1. min/max values [ Time Frame: 24 hours ]
    To report the minimum/maximum values for: respiratory rate per hour among women who receive neuraxial opioids for postoperative analgesia

  2. Min/max values [ Time Frame: 24 hours ]
    - To report the minimum/maximum values for: respiratory rate per hour for women who undergo cesarean delivery and do not receive standard low-dose neuraxial opioids.

  3. patient anesthesia selection [ Time Frame: 24 hours ]
    To report the number of women who select each of the anesthesia modalities offered (standard low dose; ultra-low dose morphine; or truncal nerve block (QLB or ESP).



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female pregnant
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women undergoing elective cesarean delivery under spinal anesthesia
Criteria

Inclusion Criteria:American Society of Anesthesiologists physical status class II or III, 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:

Contraindication for epidural analgesia (bleeding diathesis, neuropathy, severe scoliosis, previous spine surgery, local anesthetic allergy) 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250233


Contacts
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Contact: Carolyn Weiniger, MB ChB 972584681838 carolynw@tlvmc.gov.il
Contact: Miri Davidovich 97236974758 mirid@tlvmc.gov.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Stanford University
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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT04250233    
Other Study ID Numbers: TASMC-2020-CFW-608-19-CTIL
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No