Cesarean Delivery; Neuraxial OpioidsNCT04250233
Respiratory Rate After Cesarean Delivery
An observational study of Cesarean Delivery; Neuraxial Opioids, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Cesarean Delivery; Neuraxial Opioids
- What is being tested?
- Respiratory Monitor
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 11 Aug 2021to 26 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Women undergoing elective cesarean delivery under spinal anesthesia
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the detailed description
Respiratory monitoring device will be used to count respiratory rate continuously, as opposed to the intermittent nursing respiratory rate (RR) counts once per hour. The device counts respiration (RR) 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 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
- Cesarean Delivery; Neuraxial Opioids
- Being tested
- Respiratory Monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory MonitorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard neuraxial opioids | Standard neuraxial anesthesia for cesarean delivery (heavy bupivacaine 10 mg; fentanyl 10-25 mic; and low dose intrathecal morphine Receives: Device: Respiratory Monitor | |
| 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. Receives: Device: Respiratory Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory rate ≤8
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.
Measured: up to 24 hours
Secondary outcomes (11)
respiratory rate per min
To report the minimum/maximum values for: respiratory rate per min among women who receive standard low dose neuraxial opioids for postoperative analgesia and to compare to other groups
Measured: up to 24 hours
oxygen saturation
- To report the minimum/maximum values for: oxygen saturation for women who undergo cesarean delivery and receive standard low-dose neuraxial opioids and to compare to other groups.
Measured: up to 24 hours
heart rate
- To report the minimum/maximum values for: heart rate for women who undergo cesarean delivery and receive standard low-dose neuraxial opioids and to compare to other groups.
Measured: up to 24 hours
apnea
- To report the frequency of apnea for women who undergo cesarean delivery and receive standard low-dose neuraxial opioids and to compare to other groups.
Measured: up to 24 hours
side effects
incidence ie no of women with and without pruritus, nausea, vomiting, other side effects of analgesia and compare between groups
Measured: up to 24 hours
additional analgesia
post operative analgesia used for each patient in 24 hours (paracetamol, ibuprofen, optalgin, other) and compare between groups
Measured: up to 24 hours
antiemetic
antiemetic administration for each patient in 24 hours and compare between groups - women with and without resp depression
Measured: up to 24 hours
duration of monitor period
duration of use of monitor (pulse oximeter, RR, HR) - all and each of the components
Measured: up to 24 hours
nurse outcomes
nurse measured outcomes - the number of the RR recorded, and compare between groups - women with and without resp depression
Measured: up to 24 hours
patient experience
patient will be asked for verbal descriptions after being prompted - how did you find the experience of using the device to assess patient experience of the device (discomfort, nursing interference, mobility interference, family visit interference, itchy, nausea, others)
Measured: up to 24 hours
patient anesthesia selection
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/TAP/ESP).
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start11 Aug 2021
- Primary completion26 Mar 2023
- Study completion26 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean Delivery; Neuraxial OpioidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Stanford University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250233
- Sponsor's protocol ID
- TASMC-2020-CFW-608-19-CTIL
- Status last verified
- Apr 2023
- First submitted
- 29 Jan 2020
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lustig A, Carvalho B, Haim S, Guo N, Greenberger C, Karol D, Aptekman B, Weiniger CF. Prospective Study of Postoperative Respiratory Depression Metrics After Cesarean Delivery Among Women Receiving Intrathecal Morphine. Anesth Analg. 2026 Jul 1;143(1):113-121. doi: 10.1213/ANE.0000000000007908. Epub 2026 Mar 5.
PubMed 41785463
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04250233
- Acronym / sponsor ID
- TASMC-2020-CFW-608-19-CTIL
- Conditions
- Cesarean Delivery; Neuraxial Opioids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Stanford University
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 26 Mar 2023 (actual)
- Study completion
- 26 Mar 2023 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Respiratory monitoring device will be used to count respiratory rate continuously, as opposed to the intermittent nursing respiratory rate (RR) counts once per hour. The device counts respiration (RR) 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard neuraxial opioids | – | Device: Respiratory MonitorStandard neuraxial anesthesia for cesarean delivery (heavy bupivacaine 10 mg; fentanyl 10-25 mic; and low dose intrathecal morphine |
| Non standard neuraxial opioids | – | Device: Respiratory MonitorNon 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women undergoing elective cesarean delivery under spinal anesthesia
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory MonitorAll 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. | Device | Non standard neuraxial opioids, Standard neuraxial opioids |
Primary outcome
Respiratory rate ≤8
Time frame: up to 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.
11 secondary outcomes
respiratory rate per min
Time frame: up to 24 hours
oxygen saturation
Time frame: up to 24 hours
heart rate
Time frame: up to 24 hours
apnea
Time frame: up to 24 hours
side effects
Time frame: up to 24 hours
additional analgesia
Time frame: up to 24 hours
antiemetic
Time frame: up to 24 hours
duration of monitor period
Time frame: up to 24 hours
nurse outcomes
Time frame: up to 24 hours
patient experience
Time frame: up to 24 hours
patient anesthesia selection
Time frame: up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Derived from this study: PubMed 41785463Lustig A, Carvalho B, Haim S, Guo N, Greenberger C, Karol D, Aptekman B, Weiniger CF. Prospective Study of Postoperative Respiratory Depression Metrics After Cesarean Delivery Among Women Receiving Intrathecal Morphine. Anesth Analg. 2026 Jul 1;143(1):113-121. doi: 10.1213/ANE.0000000000007908. Epub 2026 Mar 5.
- Individual participant dataSharing planned: No
Related trials for Cesarean Delivery; Neuraxial Opioids
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Delivery; Neuraxial Opioids, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory rate ≤8 (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04250233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.