NCT04250233

Respiratory Rate After Cesarean Delivery

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-08-11
• Primary completion: 2023-03-26
• Completion: 2023-03-26
• First posted: 2020-01-31
• Last updated: 2023-04-19

Locations

1 site across 1 country: Israel