An observational study in Cesarean Delivery; Neuraxial Opioids, sponsored by Tel-Aviv Sourasky Medical Center. Completed at 1 site in Israel. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-04-19.
Sponsored by Tel-Aviv Sourasky Medical Center · Observational
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
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.
Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.
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Women undergoing elective cesarean delivery under spinal anesthesia
Exclusion Criteria:
Standard neuraxial anesthesia for cesarean delivery (heavy bupivacaine 10 mg; fentanyl 10-25 mic; and low dose intrathecal morphine
Device: Respiratory Monitor
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.
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.
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.
Time frame: up to 24 hours
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: up to 24 hours
additional analgesia
post operative analgesia used for each patient in 24 hours (paracetamol, ibuprofen, optalgin, other) and compare between groups
Time frame: up to 24 hours
antiemetic
antiemetic administration for each patient in 24 hours and compare between groups - women with and without resp depression
Time frame: up to 24 hours
duration of monitor period
duration of use of monitor (pulse oximeter, RR, HR) - all and each of the components
Time frame: 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
Time frame: 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)
Time frame: 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).
Time frame: up to 24 hours
Plan to share: No
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Tel-Aviv Sourasky Medical Center