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

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

Study Overview

• Status: Completed
• Conditions: Cesarean Delivery; Neuraxial Opioids
• Intervention / Treatment: Device: Respiratory Monitor

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

• Study Contact: Name: Carolyn Weiniger, MB ChB; Phone Number: 972584681838; Email: carolynw@tlvmc.gov.il

Study Locations

• Israel
  • Tel Aviv, Israel
    • Tel Aviv Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women undergoing elective cesarean delivery under spinal anesthesia

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard neuraxial opioids; Standard neuraxial anesthesia for cesarean delivery (heavy bupivacaine 10 mg; fentanyl 10-25 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	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	up to 24 hours
additional analgesia	post operative analgesia used for each patient in 24 hours (paracetamol, ibuprofen, optalgin, other) and compare between groups	up to 24 hours
antiemetic	antiemetic administration for each patient in 24 hours and compare between groups - women with and without resp depression	up to 24 hours
duration of monitor period	duration of use of monitor (pulse oximeter, RR, HR) - all and each of the components	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	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)	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).	up to 24 hours

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborators: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Actual): March 26, 2023
• Study Completion (Actual): March 26, 2023

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: TASMC-2020-CFW-608-19-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No