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Completed

NCT Number: NCT04250233

Respiratory Rate After Cesarean Delivery

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

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Tel AViv Sourasky Medical Center

Tel Aviv, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Respiratory Monitor

Device

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 outcomes

  1. 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.

Secondary outcomes

  1. respiratory rate per min

    Time frame: up to 24 hours

    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

  2. oxygen saturation

    Time frame: up to 24 hours

    • 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.
  3. heart rate

    Time frame: up to 24 hours

    • 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.
  4. apnea

    Time frame: up to 24 hours

    • 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.
  5. side effects

    Time frame: up to 24 hours

    incidence ie no of women with and without pruritus, nausea, vomiting, other side effects of analgesia and compare between groups

  6. additional analgesia

    Time frame: up to 24 hours

    post operative analgesia used for each patient in 24 hours (paracetamol, ibuprofen, optalgin, other) and compare between groups

  7. antiemetic

    Time frame: up to 24 hours

    antiemetic administration for each patient in 24 hours and compare between groups - women with and without resp depression

  8. duration of monitor period

    Time frame: up to 24 hours

    duration of use of monitor (pulse oximeter, RR, HR) - all and each of the components

  9. nurse outcomes

    Time frame: up to 24 hours

    nurse measured outcomes - the number of the RR recorded, and compare between groups - women with and without resp depression

  10. patient experience

    Time frame: up to 24 hours

    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)

  11. patient anesthesia selection

    Time frame: up to 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/TAP/ESP).

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Collaborators

  • Stanford University

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2020
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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